Phase 3
Completed N=365
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
Diabetes Type 2
Source: ClinicalTrials.gov NCT01652729 ↗
Enrolled (actual)
365
Serious AEs
1.9%
Results posted
Apr 2015
Primary outcomePrimary: Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 — -1.13; -0.75; -0.40 percentage of total hemoglobin — p=0.0010
Summary
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 |
-1.13; -0.75; -0.40 | 0.0010 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c <7% at Week 28 |
3.3; 1.6; 3.3; 96.7; 98.4; 96.7 | 0.0489 sig |
| SECONDARY Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 |
-21.3; -11.3; 9.6 | 0.0924 |
| SECONDARY Change in Body Weight (kg) From Baseline to Week 28 |
-1.12; -1.19; 0.15 | 0.8625 |
| SECONDARY Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8) |
-59.57; -23.61; -38.68 | 0.0248 sig |
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Diagnosed with type 2 diabetes mellitus
- HbA1c of 7.1% to 11.0%, inclusive, at screening
- Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
- Fasting plasma glucose concentration =500 mg/dL
- Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
- History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
- Active cardiovascular disease
- Presence or history of severe congestive heart failure
- Central nervous system disease, including epilepsy
- Liver disease
- History of severe gastrointestinal diseases
- Clinically significant malignant disease
- Repeated severe hypoglycemia within the last 6 months
- Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
- Any DPP-4 inhibitor within 3 months prior screening
Data sourced from ClinicalTrials.gov (NCT01652729). 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.