A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

• Status: Withdrawn
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Exenatide; Glimepiride

Criteria

Inclusion Criteria:

• HbA1c between 7.5% - 10.5%

• on metformin monotherapy

• BMI between 25 & 45 kg/m2

Exclusion Criteria:

• On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months

• history of pancreatitis