Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 2

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Key facts

Study ID

NCT00943917

Run by

Intarcia Therapeutics

People needed

155

Starts

2009-08-01

Expected to finish

2011-02-01

Last updated by the study team

2015-04-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females age 18-70 years
• Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
• On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
• Fasting plasma glucose < 240 mg/dL at Screening Visit 1
• HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

You may not qualify if…

• Prior treatment with exenatide
• Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
• History of type 1 diabetes and/or history of diabetic ketoacidosis
• Body mass index ≥ 40 kg/m2;
• History of organ transplantation

Where it is running

• Study Site — Traverse City, Michigan, United States
• Study Site — Troy, Michigan, United States
• Study Site — Ypsilanti, Michigan, United States
• Study Site — Minneapolis, Minnesota, United States
• Study Site — Las Vegas, Nevada, United States
• Study Site — New Hyde Park, New York, United States
• Study Site — Charlotte, North Carolina, United States
• Study Site — Hickory, North Carolina, United States
• Study Site — Cincinnati, Ohio, United States
• Study Site — Cincinnati, Ohio, United States
• Study Site — Franklin, Ohio, United States
• Study Site — Kettering, Ohio, United States
• Study Site — Norman, Oklahoma, United States
• Study Site — Eugene, Oregon, United States
• Study Site — Rapid City, South Dakota, United States
• Study Site — Austin, Texas, United States
• Study Site — Austin, Texas, United States
• Study Site — Dallas, Texas, United States
• Study Site — Dallas, Texas, United States
• Study Site — Irving, Texas, United States
• Study Site — San Antonio, Texas, United States
• Study Site — San Antonio, Texas, United States
• Study Site — West Jordan, Utah, United States
• Study Site — Norfolk, Virginia, United States
• Study Site — Olympia, Washington, United States

Full record on ClinicalTrials.gov

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