NCT00943917

Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Intarcia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	ITCA 650	ITCA 650 (continuous delivery of exenatide in DUROS)
DRUG	Exenatide Injection	twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
OTHER	Ex Inj/ITCA 650	twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2011-02-01
• First posted: 2009-07-22
• Last updated: 2015-04-13
• Results posted: 2012-05-03

Locations

50 sites across 1 country: United States