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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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