Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Overview
The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.
Full Title of Study: “Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2010
Interventions
- Other: ITCA 650
- ITCA 650 (continuous delivery of exenatide in DUROS)
- Drug: Exenatide Injection
- twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
- Other: Ex Inj/ITCA 650
- twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Arms, Groups and Cohorts
- Experimental: ITCA 650 20 mcg/day
- Experimental: ITCA 650 40 mcg/day
- Active Comparator: Exenatide Injection
- Experimental: ITCA 650 20/20
- Experimental: ITCA 650 20/60
- Experimental: ITCA 650 40/40
- Experimental: ITCA 650 40/80
- Experimental: Ex Inj/ITCA 650 40
- Experimental: Ex Inj/ITCA 650 60
Clinical Trial Outcome Measures
Primary Measures
- Mean Change in HbA1c (Per Protocol)
- Time Frame: Day 0 and Week 12
- Mean change in HbA1c over first 12 weeks (Stage I)
- Mean Change in HbA1c (ITT)
- Time Frame: Day 0 to Week 12
- Mean change in HbA1c through Week 12
- Mean Change in HbA1c (Per Protocol)
- Time Frame: Day 0 to Week 24
- Mean change in HbA1c through Week 24
- Mean Change in HbA1c (ITT)
- Time Frame: Day 0 to Week 24
- Mean change in HbA1c through Week 24
- Mean Change in HbA1c (Per Protocol)
- Time Frame: Day 0 to Week 48
- Mean change in HbA1c through Week 48
- Mean Change in HbA1c (ITT)
- Time Frame: Day 0 to Week 48
- Mean change in HbA1c through Week 48
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Intarcia Therapeutics
- Provider of Information About this Clinical Study
- Sponsor
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