A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/9/2019 |
| Start Date: | May 2013 |
| End Date: | January 2018 |
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients
with initial HbA1c >10% by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment
with ITCA 650 60 mcg/day
with initial HbA1c >10% by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment
with ITCA 650 60 mcg/day
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
We found this trial at
50
sites
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2492 Walnut Avenue
Tustin, California 92780
Tustin, California 92780
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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