Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01652716

Run by

AstraZeneca

People needed

377

Starts

2013-01-01

Expected to finish

2014-08-01

Last updated by the study team

2018-07-03

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 7.1 to 11%, inclusive, at screening
• Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
• Body mass index (BMI) <=45 kg/m2, inclusive, at screening
• Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

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
• 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

Where it is running

• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Escondido, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — Lomita, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Oviedo, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Ponte Vedra, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Paducah, Kentucky, United States
• Research Site — Lake Charles, Louisiana, United States
• Research Site — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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