Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.

Key facts

Study ID

NCT03060980

Run by

Intarcia Therapeutics

People needed

245

Starts

2017-03-03

Expected to finish

2018-01-26

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…

• Diagnosis of T2D 3 months prior to the Screening Visit.
• Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
• Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).

You may not qualify if…

• History of type 1 diabetes.
• Prior participation in a clinical study involving ITCA 650.
• Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
• History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
• History or evidence of acute or chronic pancreatitis.
• History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
• Treatment of medications that affect GI motility.
• History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
• Women that are pregnant, lactating, or planning to become pregnant.
• Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.

Where it is running

• Thomas C. Lenzmeier, M.D., P.C. — Glendale, Arizona, United States
• Family Practice Specialists — Phoenix, Arizona, United States
• Central Phoenix Medical Center — Phoenix, Arizona, United States
• Fiel Family and Sports Medicine — Tempe, Arizona, United States
• Arizona Community Physicians — Tucson, Arizona, United States
• Orange Grove Family Practice — Tucson, Arizona, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Radiant Research — Carlsbad, California, United States
• Research Center of Fresno, Inc. — Fresno, California, United States
• Marin Endocrine Care and Research, Inc. — Greenbrae, California, United States
• National Research Institute — Huntington Park, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute — Montclair, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Center for Clinical Trials of Sacramento, Inc. — Sacramento, California, United States
• Denver VA Medical Center — Aurora, Colorado, United States
• Radiant Research — Centennial, Colorado, United States
• Colorado Springs Health Partners - East — Colorado Springs, Colorado, United States
• Columbine Family Practice — Littleton, Colorado, United States
• Nature Coast Clinical Reseaerch - Crystal River — Crystal River, Florida, United States
• Indago Research and Health Center, Inc. — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Research Institure of South Florida — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Fountain Hills Family Practice, P.C. — Fountain Hills, Arizona, United States

Full record on ClinicalTrials.gov

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