Trials / Completed
CompletedNCT02638805
Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Intarcia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITCA 650 Osmotic Mini Pump 20/60 mcg/day | ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day |
| DRUG | ITCA 650 Osmotic Mini Pump 60 mcg/day | ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day |
| DRUG | Metformin | Stable dose for at least 3 months (at least 1000 mg/day) |
| DRUG | Liraglutide | Stable dose for at least 3 months (at least 1.2 mg/day) |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2015-12-23
- Last updated
- 2018-11-05
Locations
36 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02638805. Inclusion in this directory is not an endorsement.