Trials / Completed
CompletedNCT01455870
A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 535 (actual)
- Sponsor
- Intarcia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITCA 650 60 mcg/day | exenatide in DUROS |
| DRUG | sitagliptin | oral sitagliptin 100 mg/day |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2011-10-20
- Last updated
- 2016-06-02
Locations
54 sites across 5 countries: United States, Croatia, Denmark, Germany, Latvia
Source: ClinicalTrials.gov record NCT01455870. Inclusion in this directory is not an endorsement.