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
- Conditions
- Diabetes Type 2
- Interventions
- Registration Number
- NCT01652729
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
- 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 <280 mg/dL (15.5 mmol/L) at screening
- Body mass index of <45 kg/m2 at screening
- Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)
- History of pancreatitis or triglycerides >=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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide once weekly suspension Exenatide once weekly suspension Exenatide once weekly suspension 2mg subcutaneous injection Sitagliptin 100mg Sitagliptin Overencapsulated Sitagliptin 100mg oral tablet once daily Placebo Placebo Placebo oral capsule once daily
- Primary Outcome Measures
Name Time Method Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 Baseline to Week 28 Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 Baseline to Week 28 The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
Change in Body Weight (kg) From Baseline to Week 28 Baseline to Week 28 The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Percentage of Subjects Achieving HbA1c <7% at Week 28 Baseline to Week 28 Percentage of subjects achieving HbA1c target values of \< 7.0% at Week 28/Study Termination.
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8) Baseline to Week 16 The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (\< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.
Trial Locations
- Locations (2)
Research Site
🇺🇸Spokane, Washington, United States
Reseach Site
🇺🇸Rapid City, South Dakota, United States