Trials / Completed
CompletedNCT01455857
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 460 (actual)
- Sponsor
- Intarcia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITCA 650 | ITCA 650 is exenatide in DUROS |
| OTHER | ITCA placebo | Formulation in DUROS (no exenatide) |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2014-08-01
- Completion
- 2014-09-01
- First posted
- 2011-10-20
- Last updated
- 2015-08-18
Locations
121 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01455857. Inclusion in this directory is not an endorsement.