Status:
COMPLETED
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00308139
Start Date
April 1 2006
End Date
August 1 2014
Last Update
August 26 2015
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site 182
Encino, California, United States, 91436
2
Research Site 171
La Jolla, California, United States, 92037
3
Research Site 518
San Diego, California, United States, 92161
4
Research Site 024
Walnut Creek, California, United States, 94598