Status:
COMPLETED
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.
Exclusion
- Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
- Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00085969
Start Date
September 1 2003
End Date
January 1 2004
Last Update
February 23 2015
Active Locations (23)
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1
The Whittier Institute for Diabetes
La Jolla, California, United States, 92037
2
VA Medical Center
San Diego, California, United States, 92161
3
MedStar Research Institute
Washington D.C., District of Columbia, United States, 20003
4
Internal Medicine Associates, Department of Research
Fort Myers, Florida, United States, 33901