Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.

Key facts

Study ID

NCT00308139

Run by

AstraZeneca

People needed

303

Starts

2006-04-01

Expected to finish

2014-08-01

Last updated by the study team

2015-08-26

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
• Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
• Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
• (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105

You may not qualify if…

• Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
• Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
• Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
• Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
• Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
• Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
• Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
• Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
• Prescription or over-the-counter weight loss medications within 6 months of screening.
• (For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy

Where it is running

• Research Site 182 — Encino, California, United States
• Research Site 171 — La Jolla, California, United States
• Research Site 518 — San Diego, California, United States
• Research Site 024 — Walnut Creek, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site 057 — Miami, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site 149 — Indianapolis, Indiana, United States
• Research Site 099 — Lexington, Kentucky, United States
• Research Site 017 — Detroit, Michigan, United States
• Research Site 224 — Minneapolis, Minnesota, United States
• Research Site 312 — St Louis, Missouri, United States
• Research Site 023 — Butte, Montana, United States
• Research Site 053 — Rochester, New York, United States
• Research Site 002 — Durham, North Carolina, United States
• Research Site 123 — Winston-Salem, North Carolina, United States
• Research Site 405 — Cincinnati, Ohio, United States
• Research Site 557 — Marion, Ohio, United States
• Research Site 231 — Portland, Oregon, United States
• Research Site 152 — Philadelphia, Pennsylvania, United States
• Research Site 587 — Greer, South Carolina, United States
• Research Site 015 — Dallas, Texas, United States
• Research Site 009 — San Antonio, Texas, United States
• Research Site 108 — Olympia, Washington, United States
• Research Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.