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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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