A Study to Evaluate ITCA 650 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: | March 2013 |
| End Date: | September 2014 |
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes
Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is
superior to placebo when added to current therapy in reducing HbA1c in patients with type 2
diabetes.
superior to placebo when added to current therapy in reducing HbA1c in patients with type 2
diabetes.
Inclusion Criteria:
- HbA1c between 7.5% - 10%
- On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD)
alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met +
TZD, Met + TZD + SU
- BMI between 25 & 45 kg/m2
Exclusion Criteria:
- taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors,
meglitinides or insulin within last 3 months
- history of pancreatitis
We found this trial at
133
sites
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