A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | May 2013 |
End Date: | July 2015 |
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
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin
monotherapy in patients with type 2 diabetes.
monotherapy 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:
- taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase
inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
We found this trial at
51
sites
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