A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
Sponsored by Intarcia Therapeutics
About this trial
Last updated 7 years ago
Study ID
ITCA 650-CLP-103-Sub-Study
Status
Terminated
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 80 Years
All Sexes
Trial Timing
Ended 8 years ago
What is this trial about?
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day
What are the participation requirements?
Inclusion Criteria
* Men or women age 18 to 80 years with type 2 diabetes
* On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
* HbA1c >10.0% and ≤12.0%
Exclusion Criteria
* Prior treatment with any GLP-1 receptor agonist
* History of hypersensitivity to exenatide or liraglutide
* FPG >300 mg/dL
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
* Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis