Insulin Glargine Versus Twice-Daily NPH
This study has been completed.
Sponsor:
Charles Drew University of Medicine and Science
Collaborator:
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00687453
First received: May 27, 2008
Last updated: March 25, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: September 15, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Type 2 Diabetes Mellitus |
| Interventions: |
Drug: Insulin glargine at bedtime instead of NPH Drug: NPH twice-daily |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruitment from Sep 2002 to Dec 2008. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
|
Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles. 3 subjects not randomized due to protocol violations. |
Reporting Groups
| Description | |
|---|---|
| Insulin Glargine at Bedtime | Bedtime insulin glargine titrated to morning fasting glucose readings |
| NPH Twice-daily | Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively |
Participant Flow: Overall Study
| Insulin Glargine at Bedtime | NPH Twice-daily | |
|---|---|---|
| STARTED | 11 | 13 |
| COMPLETED | 8 | 7 |
| NOT COMPLETED | 3 | 6 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Insulin Glargine at Bedtime | Bedtime insulin glargine titrated to morning fasting glucose readings |
| NPH Twice-daily | Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively |
| Total | Total of all reporting groups |
Baseline Measures
| Insulin Glargine at Bedtime | NPH Twice-daily | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
11 | 13 | 24 |
|
Age
[units: years] Mean ± Standard Deviation |
55.6 ± 7.0 | 54.6 ± 7.6 | 55.0 ± 7.2 |
|
Gender
[units: participants] |
|||
| Female | 8 | 10 | 18 |
| Male | 3 | 3 | 6 |
|
Ethnicity (NIH/OMB)
[units: participants] |
|||
| Hispanic or Latino | 9 | 9 | 0 |
| Not Hispanic or Latino | 2 | 4 | 0 |
|
Hemoglobin A1c
[units: Percent] Mean ± Standard Deviation |
9.1 ± 1.4 | 9.5 ± 1.2 | 9.3 ± 1.3 |
|
Fasting Plasma Glucose
[units: mg/dL] Mean ± Standard Deviation |
146 ± 75 | 145 ± 34 | 146 ± 56 |
|
Diabetes Duration
[units: Years] Mean ± Standard Deviation |
9.4 ± 3.5 | 11.5 ± 4.0 | 10.6 ± 3.8 |
|
Body Mass Index
[units: kg/m^2] Mean ± Standard Deviation |
29.9 ± 4.1 | 33.5 ± 6.6 | 31.8 ± 5.8 |
Outcome Measures
| 1. Primary: | Hemoglobin A1c Change From Baseline [ Time Frame: Baseline to 6 months ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Hemoglobin A1c Change From Baseline |
| Measure Description | No text entered. |
| Time Frame | Baseline to 6 months |
| 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. |
|---|
| ITT (LOCF) |
Reporting Groups
| Description | |
|---|---|
| Insulin Glargine at Bedtime | Bedtime insulin glargine titrated to morning fasting glucose readings |
| NPH Twice-daily | Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively |
Measured Values
| Insulin Glargine at Bedtime | NPH Twice-daily | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
11 | 13 |
|
Hemoglobin A1c Change From Baseline
[units: Percent] Mean ± Standard Deviation |
-0.8 ± 0.9 | -1.0 ± 1.2 |
No statistical analysis provided for Hemoglobin A1c Change From Baseline
| 2. Secondary: | Frequency of Pre-supper Glucose Readings 120 mg/dL or Less [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 3. Secondary: | Frequency of Total Hypoglycemic Reactions [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
Yes
| 4. Secondary: | Frequency of Severe Hypoglycemic Reactions [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
Yes
| 5. Secondary: | Body Mass Index Change From Baseline [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 6. Secondary: | Total Daily Insulin Dose [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 7. Secondary: | Any Adverse Event Other Than Hypoglycemia [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
Yes
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
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 |
|---|
| Early termination leading to smaller than anticipated enrollment. |
Results Point of Contact:
Name/Title: Stanley H. Hsia, MD
Organization: Charles R. Drew University of Medicine and Science
phone: 323-357-3633
e-mail: stanleyhsia@cdrewu.edu
Organization: Charles R. Drew University of Medicine and Science
phone: 323-357-3633
e-mail: stanleyhsia@cdrewu.edu
No publications provided
| Responsible Party: | Charles Drew University of Medicine and Science |
| ClinicalTrials.gov Identifier: | NCT00687453 History of Changes |
| Other Study ID Numbers: | 03-02-519, U54RR014616 |
| Study First Received: | May 27, 2008 |
| Results First Received: | September 15, 2010 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Institutional Review Board |