Phase 3
Completed N=377
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01652716 ↗Enrolled (actual)
377
Serious AEs
7.7%
Results posted
Sep 2015
Primary outcomePrimary: Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 — -1.39; -1.02 Percentage of total hemoglobin — p=0.0072
Summary
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 |
-1.39; -1.02 | 0.0072 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c <7% at Week 28 |
3.9; 1.4; 95.2; 98.6; 49.3; 43.2 | 0.2247 |
| SECONDARY Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 |
-32.7; -22.5 | 0.1656 |
| SECONDARY Change in Body Weight (kg) From Baseline to Week 28 |
-1.49; -1.89 | 0.3744 |
| SECONDARY Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 |
-87.00; -113.74 | 0.0985 |
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Diagnosed with type 2 diabetes mellitus
- HbA1c 7.1 to 11%, inclusive, at screening
- Fasting plasma glucose =500 mg/dL
- Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
- Active cardiovascular disease
- Presence of congestive heart failure
- Liver disease
- History of severe gastrointestinal diseases
- Repeated severe hypoglycemia within the last 6 months
- Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
- Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
Data sourced from ClinicalTrials.gov (NCT01652716). 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.