Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Key facts

Study ID

NCT02229383

Run by

AstraZeneca

People needed

464

Starts

2014-09-06

Expected to finish

2016-08-29

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
• Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
• Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
• Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
• a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
• a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit

You may not qualify if…

• Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
• History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
• Positive serological test for hepatitis B or hepatitis C

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Muscle Shoals, Alabama, United States
• Research Site — Tempe, Arizona, United States
• Research Site — Chino, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — El Cajon, California, United States
• Research Site — Fresno, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Hills, California, United States
• Research Site — Tustin, California, United States
• Research Site — West Hills, California, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Brooksville, Florida, United States
• Research Site — Chiefland, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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