Phase 3
Completed N=427
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00935532 ↗Enrolled (actual)
427
Serious AEs
2.6%
Results posted
Oct 2012
Primary outcomePrimary: Change in HbA1c From Baseline to Endpoint (Week 26) — -1.11; -0.68 percentage of total hemoglobin — p=<.001
Summary
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Endpoint (Week 26) |
-1.11; -0.68 | <.001 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c<=7% |
42.2; 21.0 | <.001 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c<=6.5% |
20.6; 4.2 | <.001 sig |
| SECONDARY Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26) |
-46.09; -40.82 | 0.103 |
| SECONDARY Change in Body Weight From Baseline to Endpoint (Week 26) |
-1.67; 0.34 | <.001 sig |
| SECONDARY Change in Total Cholesterol From Baseline to Endpoint (Week 26) |
-14.21; -6.32 | <.001 sig |
| SECONDARY Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26) |
-0.99; -0.71 | 0.689 |
| SECONDARY Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline |
1.00; 1.00 | 0.990 |
| SECONDARY Change in Blood Pressure From Baseline to Endpoint (Week 26) |
-4.5; -2.6; -1.1; -2.5 | — |
| SECONDARY Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events |
0.00; 0.00 | — |
| SECONDARY Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events |
0.01; 0.16 | — |
Eligibility Criteria
Inclusion Criteria
- present with type 2 diabetes mellitus
- HbA1c between 7.1% and 11.0% inclusive
- body mass index (BMI) of >18kg/m2 and 14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
- Have been treated with drugs that promote weight loss within 90 days prior to study start.
- Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.
- Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
- Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
- Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
- Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
- Have donated blood within 30 days prior to study start.
Data sourced from ClinicalTrials.gov (NCT00935532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.