Status:
COMPLETED
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
Lead Sponsor:
Intarcia Therapeutics
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT01455857
Start Date
March 1 2013
End Date
September 1 2014
Last Update
August 18 2015
Active Locations (121)
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1
Study Site
Birmingham, Alabama, United States, 35235
2
Study Site
Gulf Shores, Alabama, United States, 36542
3
Study Site
Huntsville, Alabama, United States, 35801
4
Study Site
Chandler, Arizona, United States, 85224