Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00560417

First received: November 15, 2007

Last updated: January 12, 2011

Last verified: January 2011

History of Changes

Results First Received: November 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Insulin Lispro Protamine Suspension Drug: Insulin Glargine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Intention to Treat (ITT) Population consisted of all randomized participants who received at least one dose of study drug and had at least one post-baseline measurement.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Participant Flow: Overall Study

	ILPS	Glargine
STARTED	171	168
Intention to Treat (ITT) Population	170	167
COMPLETED	154	151
NOT COMPLETED	17	17
Adverse Event	3	2
Entry Criteria Not Met	1	0
Lost to Follow-up	0	1
Physician Decision	2	6
Protocol Violation	6	5
Sponsor Decision	2	0
Withdrawal by Subject	3	3

Baseline Characteristics

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Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
Total	Total of all reporting groups

Baseline Measures

	ILPS	Glargine	Total
Number of Participants [units: participants]	171	168	339
Age [units: years] Mean ± Standard Deviation	56.51 ± 9.73	56.24 ± 9.33	56.38 ± 9.52
Gender [units: participants]
Female	95	75	170
Male	76	93	169
Race/Ethnicity, Customized [units: participants]
Black or African American	13	14	27
East Asian	5	6	11
Hispanic	21	17	38
Native American	0	1	1
West Asian (Indian sub-continent)	2	0	2
White	130	130	260
Region of Enrollment [units: participants]
United States	165	165	330
Puerto Rico	6	3	9
Body Mass Index ^[1] [units: kilograms/square meters (kg/m^2)] Mean ± Standard Deviation	34.92 ± 5.21	34.78 ± 5.17	34.85 ± 5.18
Body Weight [units: Kilograms] Mean ± Standard Deviation	101.57 ± 18.67	102.33 ± 19.73	101.95 ± 19.18
Hemoglobin A1C [units: percent of glycosylated hemoglobin] Mean ± Standard Deviation	8.21 ± 0.79	8.22 ± 0.80	8.22 ± 0.79
Sulfonylurea Group ^[2] [units: participants]
Yes	108	110	218
No	63	58	121
Duration of Diabetes [units: years] Mean ± Standard Deviation	9.51 ± 5.98	10.31 ± 6.63	9.91 ± 6.31

[1]	Body mass index is an estimate of body fat based on body weight divided by height squared.
[2]	Participants taking a sulfonylurea at baseline.

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Primary
Measure Title	Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Measure Description	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
Time Frame	Baseline, Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) [units: percent of glycosylated hemoglobin] Least Squares Mean ± Standard Error
Baseline	8.48 ± 0.04	8.47 ± 0.04
Endpoint (LOCF) Change	-1.21 ± 0.07	-1.43 ± 0.07

Statistical Analysis 1 for Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Mean Difference (Final Values) ^[3]	0.22
95% Confidence Interval	( 0.06 to 0.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Noninferiority margin was prespecified at 0.4%
[3]	Other relevant estimation information:
	No text entered.

2. Secondary:

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) [ Time Frame: 24 weeks, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Measure Description	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Time Frame	24 weeks, Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) [units: percent of glycosylated hemoglobin] Least Squares Mean ± Standard Error
24 weeks	6.94 ± 0.07	6.70 ± 0.06
Endpoint (LOCF)	7.00 ± 0.07	6.78 ± 0.07

Statistical Analysis 1 for Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.003
Mean Difference (Final Values) ^[4]	0.24
95% Confidence Interval	( 0.08 to 0.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for 24 weeks.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.008
Mean Difference (Final Values) ^[4]	0.22
95% Confidence Interval	( 0.06 to 0.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint (LOCF)
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) [ Time Frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Measure Description	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Time Frame	Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) [units: percent of glycosylated hemoglobin] Least Squares Mean ± Standard Error
Baseline	8.48 ± 0.04	8.47 ± 0.04
24 Weeks Change	-1.25 ± 0.07	-1.49 ± 0.06
Endpoint (LOCF) Change	-1.21 ± 0.07	-1.43 ± 0.07

Statistical Analysis 1 for Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.003
Mean Difference (Final Values) ^[4]	0.24
95% Confidence Interval	( 0.08 to 0.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for 24 Weeks change.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.008
Mean Difference (Final Values) ^[4]	0.22
95% Confidence Interval	( 0.06 to 0.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint (LOCF) Change.
[4]	Other relevant estimation information:
	No text entered.

4. Secondary:

Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5% [ Time Frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Measure Description	No text entered.
Time Frame	Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5% [units: percent of participants]
Week 12: HbA1c <7.0%	46.9	50.7
Week 12: HbA1c <=6.5%	24.8	28.7
Week 18: HbA1c <7.0%	54.8	69.1
Week 18: HbA1c <=6.5%	30.8	37.6
Week 24: HbA1c <7.0%	55.4	63.4
Week 24: HbA1c <=6.5%	29.7	39.9
Endpoint (LOCF): HbA1c <7.0%	53.7	61.7
Endpoint (LOCF): HbA1c <=6.5%	28.4	38.9

Statistical Analysis 1 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.561

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12: HbA1c <7.0%

Statistical Analysis 2 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.511

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12: HbA1c <=6.5%

Statistical Analysis 3 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.012

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 18: HbA1c <7.0%

Statistical Analysis 4 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.269

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 18: HbA1c <=6.5%

Statistical Analysis 5 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.161

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 24: HbA1c <7.0%

Statistical Analysis 6 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.071

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 24: HbA1c <=6.5%

Statistical Analysis 7 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.177

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint (LOCF): HbA1c <7.0%

Statistical Analysis 8 for Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.060

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint (LOCF): HbA1c <=6.5%

5. Secondary:

7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Measure Description	SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.
Time Frame	Baseline, Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF) [units: milligrams per deciliter (mg/dL)] Mean ± Standard Deviation
Baseline Morning Pre-Meal	175.41 ± 39.54	180.86 ± 38.95
Baseline Morning Postprandial	195.31 ± 54.65	190.84 ± 54.95
Baseline Midday Pre-Meal	165.18 ± 43.51	166.34 ± 47.64
Baseline Midday Postprandial	193.22 ± 46.95	200.25 ± 54.64
Baseline Evening Pre-Meal	173.33 ± 44.60	175.14 ± 43.35
Baseline Evening Postprandial	189.00 ± 49.62	184.92 ± 49.42
Baseline 0300 Hours	170.51 ± 43.44	172.00 ± 39.10
Baseline Daily Mean 7-Point Blood Glucose	180.19 ± 36.95	180.72 ± 38.17
Baseline Daily Mean Pre-Meal	170.60 ± 36.06	172.66 ± 38.60
Baseline Daily Mean Postprandial	192.37 ± 41.48	191.27 ± 46.11
Endpoint Morning Pre-Meal	129.63 ± 31.58	127.01 ± 29.08
Endpoint Morning Postprandial	152.32 ± 44.81	137.39 ± 36.65
Endpoint Midday Pre-Meal	132.84 ± 36.63	129.71 ± 34.34
Endpoint Midday Postprandial	161.77 ± 42.46	155.26 ± 37.86
Endpoint Evening Pre-Meal	146.03 ± 37.93	135.93 ± 33.79
Endpoint Evening Postprandial	159.14 ± 45.35	144.25 ± 34.17
Endpoint 0300 Hours	123.96 ± 35.45	127.53 ± 30.90
Endpoint Daily Mean 7-Point Blood Glucose	143.06 ± 30.00	136.17 ± 25.65
Endpoint Daily Mean Pre-Meal	135.51 ± 30.39	129.32 ± 26.54
Endpoint Daily Mean Postprandial	158.10 ± 36.81	146.12 ± 30.37

Statistical Analysis 1 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.179
Mean Difference (Final Values) ^[4]	4.28
95% Confidence Interval	( -1.97 to 10.53 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Morning Pre-Meal.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	13.96
95% Confidence Interval	( 5.72 to 22.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Morning Postprandial.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.325
Mean Difference (Final Values) ^[4]	3.80
95% Confidence Interval	( -3.79 to 11.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Midday Pre-Meal.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.051
Mean Difference (Final Values) ^[4]	8.73
95% Confidence Interval	( -0.04 to 17.50 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Midday Postprandial.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.003
Mean Difference (Final Values) ^[4]	10.92
95% Confidence Interval	( 3.66 to 18.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Evening Pre-Meal.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.002
Mean Difference (Final Values) ^[4]	14.19
95% Confidence Interval	( 5.44 to 22.94 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Evening Postprandial.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.415
Mean Difference (Final Values) ^[4]	-3.03
95% Confidence Interval	( -10.35 to 4.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint 0300 Hours.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.015
Mean Difference (Final Values) ^[4]	7.39
95% Confidence Interval	( 1.46 to 13.32 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Daily Mean 7-Point Blood Glucose.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.021
Mean Difference (Final Values) ^[4]	7.12
95% Confidence Interval	( 1.10 to 13.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Daily Mean Pre-Meal.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	11.97
95% Confidence Interval	( 5.01 to 18.93 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint Daily Mean Postprandial.
[4]	Other relevant estimation information:
	No text entered.

6. Secondary:

Glycemic Variability at Baseline and Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Glycemic Variability at Baseline and Endpoint (LOCF)
Measure Description	Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.
Time Frame	Baseline, Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Glycemic Variability at Baseline and Endpoint (LOCF) [units: mg/dL] Mean ± Standard Deviation
Baseline	41.15 ± 13.69	39.02 ± 13.52
Endpoint	36.78 ± 16.02	30.96 ± 13.24

Statistical Analysis 1 for Glycemic Variability at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	0.131
Mean Difference (Final Values) ^[4]	2.27
95% Confidence Interval	( -0.68 to 5.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Baseline.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Glycemic Variability at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	5.99
95% Confidence Interval	( 2.82 to 9.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline HbA1c Group + Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Endpoint.
[4]	Other relevant estimation information:
	No text entered.

7. Secondary:

Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) [ Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Measure Description	Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.
Time Frame	Baseline to Endpoint (LOCF) up to 24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) [units: percentage of participants]
All Reported - Endpoint	41.8	43.1
All Reported - Overall	70.6	74.9
Non-Nocturnal - Endpoint	30.6	40.1
Non-Nocturnal - Overall	62.4	70.7
Nocturnal - Endpoint	21.8	11.4
Nocturnal - Overall	47.6	37.1
Severe - Endpoint	0	0
Severe - Overall	1.8	0

Statistical Analysis 1 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.826

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for all reported hypoglycemic events at endpoint.

Statistical Analysis 2 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.394

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for all reported hypoglycemic events overall.

Statistical Analysis 3 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.070

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for non-nocturnal hypoglycemic events at endpoint.

Statistical Analysis 4 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.133

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for non-nocturnal hypoglycemic events overall.

Statistical Analysis 5 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.013

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for nocturnal hypoglycemic events at endpoint.

Statistical Analysis 6 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.061

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for nocturnal hypoglycemic events overall.

Statistical Analysis 7 for Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.248

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for severe hypoglycemic events overall.

8. Secondary:

Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year) [ Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Measure Description	Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.
Time Frame	Baseline to Endpoint (LOCF) up to 24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year) [units: episodes/participant/365 days] Mean ± Standard Deviation
All reported episodes rate - Endpoint	14.51 ± 27.75	15.29 ± 29.73
All reported episodes rate - Overall	16.27 ± 23.19	18.05 ± 24.59
Non-Nocturnal reported episodes rate - Endpoint	10.40 ± 23.46	13.20 ± 28.01
Non-Nocturnal reported episodes rate - Overall	11.36 ± 19.16	14.83 ± 21.00
Nocturnal reported episodes rate - Endpoint	4.01 ± 9.73	1.73 ± 5.53
Nocturnal reported episodes rate - Overall	4.88 ± 8.43	3.01 ± 7.21

Statistical Analysis 1 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Groups ^[1]	All groups
Method ^[2]	Negative Binomial regression model
P Value ^[3]	0.628

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for All reported episodes rate - Endpoint.

Statistical Analysis 2 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Groups ^[1]	All groups
Method ^[2]	Negative Binomial regression model
P Value ^[3]	0.570

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for All reported episodes rate - Overall.

Statistical Analysis 3 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Groups ^[1]	All groups
Method ^[2]	Negative Binomial regression model
P Value ^[3]	0.116

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Non-Nocturnal reported episodes rate - Endpoint.

Statistical Analysis 4 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Groups ^[1]	All groups
Method ^[2]	Negative Binomial regression model
P Value ^[3]	0.044

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Non-Nocturnal reported episodes rate - Overall.

Statistical Analysis 5 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Groups ^[1]	All groups
Method ^[2]	Negative Binomial regression model
P Value ^[3]	0.006

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Nocturnal reported episodes rate - Endpoint.

Statistical Analysis 6 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Groups ^[1]	All groups
Method ^[2]	Negative Binomial regression model
P Value ^[3]	0.004

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Nocturnal reported episodes rate - Overall.

9. Secondary:

Actual Body Weight at Baseline and Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Actual Body Weight at Baseline and Endpoint (LOCF)
Measure Description	No text entered.
Time Frame	Baseline, Endpoint (LOCF) up to 24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Actual Body Weight at Baseline and Endpoint (LOCF) [units: kilograms] Mean ± Standard Deviation
Baseline	101.57 ± 18.67	102.62 ± 19.58
Endpoint	101.85 ± 18.91	103.28 ± 19.42

Statistical Analysis 1 for Actual Body Weight at Baseline and Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.343

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for endpoint.

10. Secondary:

Change From Baseline in Body Weight at Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in Body Weight at Endpoint (LOCF)
Measure Description	No text entered.
Time Frame	Baseline, Endpoint (LOCF) up to 24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	170	167
Change From Baseline in Body Weight at Endpoint (LOCF) [units: kilograms] Mean ± Standard Deviation	0.27 ± 3.38	0.66 ± 3.93

Statistical Analysis 1 for Change From Baseline in Body Weight at Endpoint (LOCF)

Groups ^[1]	ILPS
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.417

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for the change in body weight at endpoint in the ILPS treatment group.

Statistical Analysis 2 for Change From Baseline in Body Weight at Endpoint (LOCF)

Groups ^[1]	Glargine
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.041

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for the change in body weight at endpoint in the glargine treatment group.

Statistical Analysis 3 for Change From Baseline in Body Weight at Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	0.343
Mean Difference (Final Values) ^[4]	-0.38
95% Confidence Interval	( -1.15 to 0.40 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.
[4]	Other relevant estimation information:
	No text entered.

11. Secondary:

Total Daily Insulin Dose at Endpoint (LOCF) [ Time Frame: Endpoint (LOCF) up to 24 weeks ]

Measure Type	Secondary
Measure Title	Total Daily Insulin Dose at Endpoint (LOCF)
Measure Description	No text entered.
Time Frame	Endpoint (LOCF) up to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups

	Description
ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values

	ILPS	Glargine
Number of Participants Analyzed [units: participants]	168	165
Total Daily Insulin Dose at Endpoint (LOCF) [units: Units of Insulin] Mean ± Standard Deviation	31.11 ± 18.87	37.93 ± 18.46

Statistical Analysis 1 for Total Daily Insulin Dose at Endpoint (LOCF)

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00560417 History of Changes
Other Study ID Numbers:	11647, F3Z-US-IOPB
Study First Received:	November 15, 2007
Results First Received:	November 12, 2010
Last Updated:	January 12, 2011
Health Authority:	United States: Food and Drug Administration

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