A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes
Overview
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
Full Title of Study: “A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: July 2014
Interventions
- Drug: ITCA 650 60 mcg/day
- exenatide in DUROS
- Drug: sitagliptin
- sitagliptin oral 100 mg/day
Arms, Groups and Cohorts
- Experimental: ITCA 650 60 mcg/day
- Active Comparator: sitagliptin
- sitagliptin 100 mg/day
Clinical Trial Outcome Measures
Primary Measures
- Change in HbA1c
- Time Frame: 39 weeks
- 39-week treatment period followed by 65-week extension period
Participating in This Clinical Trial
Inclusion Criteria
- HbA1c between 7.5%-10% – on metformin monotherapy – BMI between 25 & 45 kg/m2 Exclusion Criteria:
- taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months – history of pancreatitis
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Intarcia Therapeutics
- Provider of Information About this Clinical Study
- Sponsor
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