Overview

A Study to Evaluate ITCA 650 Compared to Glimepiride 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Withdrawn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, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors,
meglitinides or insulin within last 3 months

- history of pancreatitis