Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00085969

Run by

AstraZeneca

People needed

99

Starts

2003-09-01

Expected to finish

2004-01-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Whittier Institute for Diabetes — La Jolla, California, United States
• VA Medical Center — San Diego, California, United States
• MedStar Research Institute — Washington D.C., District of Columbia, United States
• Internal Medicine Associates, Department of Research — Fort Myers, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Innovative Research of West Florida — Largo, Florida, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Grand Rapids Associated Internists — Grand Rapids, Michigan, United States
• Radiant Research, Inc. — St Louis, Missouri, United States
• Internal Medicine Associates — Bozeman, Montana, United States
• Mercury Street Medical Group — Butte, Montana, United States
• Lovelace Scientific Resources — Las Vegas, Nevada, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Metrolina Medical Research — Charlotte, North Carolina, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• Radiant Research — Columbus, Ohio, United States
• Smith Clinic Research — Marion, Ohio, United States
• Radiant Research — Portland, Oregon, United States
• Philadelphia Health Associates - Adult Medicine — Philadelphia, Pennsylvania, United States
• Diabetes and Glandular Disease Research Associates — San Antonio, Texas, United States
• S.A.M. Clinical Research Center — San Antonio, Texas, United States
• McGuire VA Medical Center — Richmond, Virginia, United States
• Rockwood Clinic — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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