Status:
COMPLETED
A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiab...
Eligibility Criteria
Inclusion
- Has been diagnosed with type 2 diabetes mellitus
- Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
- Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
- Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
- Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over the counter antiobesity agents
Exclusion
- Has ever been exposed to exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
- Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
- Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
- Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
- Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
- Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00877890
Start Date
March 1 2009
End Date
January 1 2010
Last Update
April 7 2015
Active Locations (41)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Mesa, Arizona, United States
3
Research Site
Peoria, Arizona, United States
4
Research Site
Artesia, California, United States