A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
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ClinicalTrials.gov Identifier: NCT01785771
(Decision by Sponsor)
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
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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%
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