A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

Stopped early · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT01785771

Run by

Intarcia Therapeutics

People needed

100

Starts

2013-05-01

Expected to finish

2018-01-01

Last updated by the study team

2019-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Fundamental Research — Gulf Shores, Alabama, United States
• East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• Clinical Research Advantage, Inc. — Phoenix, Arizona, United States
• eStudySite — Chula Vista, California, United States
• Rocks Medical Research Institute, Inc. — Fresno, California, United States
• Rocks Medical Research Institute — Fresno, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Saviers Medical Group — Port Hueneme, California, United States
• University Clinical Investigatons, Inc/Diabetes Research Center — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Colorado Springs Health Partners-Briargate — Colorado Springs, Colorado, United States
• Meridien Research — Bradenton, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• New Horizon Research Center, Inc. — Miami, Florida, United States
• International Research Assocaites, LLC — Miami, Florida, United States
• Harmony Clinical Research, Inc. — North Miami Beach, Florida, United States
• Palm Harbor Medical Associates — Palm Harbor, Florida, United States
• Andres Patron, D.O., P.A. — Pembroke Pines, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Perimeter Institute for Clinical Research PRIME — Atlanta, Georgia, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Chicago Research Center — Chicago, Illinois, United States
• American Health Network of Indiana, LLC — Avon, Indiana, United States
• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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