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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Type 2

In brief

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.

Key facts

Study ID

NCT01652729

Run by

AstraZeneca

People needed

365

Starts

2013-02-01

Expected to finish

2014-04-01

Last updated by the study team

2015-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Buena Park, California, United States
• Research Site — Chino, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — North Hollywood, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — West Hills, California, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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