A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Key facts

Study ID

NCT02119819

Run by

OPKO Health, Inc.

People needed

420

Starts

2014-04-01

Expected to finish

2015-10-01

Last updated by the study team

2021-05-27

Who can join

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

You may qualify if…

• Men or women with diabetes mellitus Type 2
• Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
• Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

You may not qualify if…

• Women of child bearing potential
• Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
• Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
• Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)

Where it is running

• Valley Endocrine, Fresno — Fresno, California, United States
• National Research Institute — Los Angeles, California, United States
• Desert Medical Group Inc — Palm Springs, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Meridien Research — Bradenton, Florida, United States
• M & O Clinical Research, LLC — Fort Lauderdale, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Compass Research — Oviedo, Florida, United States
• Clinical Research of Central Florida — Winter Haven, Florida, United States
• University of Hawaii — Honolulu, Hawaii, United States
• East West Medical Institute — Honolulu, Hawaii, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Iderc, P.L.C. — Des Moines, Iowa, United States
• Cotton O'Neil Diabetes and Endocrinology Center — Topeka, Kansas, United States
• Mercy Medical Research Institute — Springfield, Missouri, United States
• St John's Mercy Medical Center — St Louis, Missouri, United States
• Mercy Health Research — Washington, Missouri, United States
• Southern New Hampshire Diabetes and Endocrinology — Nashua, New Hampshire, United States
• High Point Clinical Trials Center — High Point, North Carolina, United States
• Lillestol Research LLC — Fargo, North Dakota, United States
• The Corvallis Clinic P.C. — Corvallis, Oregon, United States
• Blair Medical Associates, Inc. — Altoona, Pennsylvania, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States

Full record on ClinicalTrials.gov

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