A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | February 2013 |
| End Date: | July 2014 |
| Contact: | Michelle Baron, MD, FACE |
| Email: | clinicaltrials@intarcia.com |
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
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.
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
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