Status:
COMPLETED
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Intarcia Therapeutics
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00943917
Start Date
August 1 2009
End Date
February 1 2011
Last Update
April 13 2015
Active Locations (50)
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1
Study Site
Chino, California, United States, 91710
2
Study Site
La Jolla, California, United States, 92037
3
Study Site
National City, California, United States, 91950
4
Study Site
Sacramento, California, United States, 95821