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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Exenatide; Sitagliptin Phosphate

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 <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)

Exclusion Criteria:

• 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