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
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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 ] |
| 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
Serious Adverse Events Other Adverse Events
| Time Frame | 6 months |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 1% |
|---|
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 |
Other Adverse Events
| Insulin Glargine at Bedtime | NPH Twice-daily | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 8/11 | 5/13 |
| Blood and lymphatic system disorders | ||
| Peripheral Edema * | ||
| # participants affected / at risk | 1/11 (9.09%) | 0/13 (0.00%) |
| # events | 1 | 0 |
| Endocrine disorders | ||
| Symptomatic Hypoglycemia † [3] | ||
| # participants affected / at risk | 8/11 (72.73%) | 5/13 (38.46%) |
| # events | 55 | 28 |
| † | Events were collected by systematic assessment |
|---|---|
| * | Events were collected by non-systematic assessment |
| [3] | Classic symptoms of hypoglycemia, relieved by carbohydrate ingestion, with or without a corroborating self-monitored glucose reading |
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 |