Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo 0.04 mL once dailyDrug: Placebo 0.04 mL twice dailyDrug: Placebo 0.08 mL once dailyDrug: B - Exenatide 10 mcg twice dailyDrug: C - Exenatide 10 mcg once daily
- Registration Number
- NCT00085969
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A2 - Placebo 0.04 mL once daily Placebo 0.04 mL once daily - D - Exenatide 20 mcg once daily Exenatide 20 mcg once daily - A1 - Placebo 0.04 mL twice daily Placebo 0.04 mL twice daily - A3 - Placebo 0.08 mL once daily Placebo 0.08 mL once daily - B - Exenatide 10 mcg twice daily B - Exenatide 10 mcg twice daily - C - Exenatide 10 mcg once daily C - Exenatide 10 mcg once daily -
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 Baseline, Day 28 Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)
- Secondary Outcome Measures
Name Time Method Change in body weight from Baseline to Day 14 and to Day 28 Baseline, Day 14, Day28 Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 Baseline, Day 14, Day 28 Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28 Baseline, Day 14, Day 28 Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Change in postprandial blood glucose concentrations from Baseline to Day 28 Baseline, Week 28 Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)
Trial Locations
- Locations (22)
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
MedStar Research Institute
🇺🇸Washington, District of Columbia, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Internal Medicine Associates, Department of Research
🇺🇸Fort Myers, Florida, United States
Radiant Research, Inc.
🇺🇸St. Louis, Missouri, United States
VA Medical Center
🇺🇸San Diego, California, United States
The Whittier Institute for Diabetes
🇺🇸La Jolla, California, United States
Innovative Research of West Florida
🇺🇸Largo, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Internal Medicine Associates
🇺🇸Bozeman, Montana, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
Philadelphia Health Associates - Adult Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Smith Clinic Research
🇺🇸Marion, Ohio, United States
Diabetes and Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
S.A.M. Clinical Research Center
🇺🇸San Antonio, Texas, United States
Grand Rapids Associated Internists
🇺🇸Grand Rapids, Michigan, United States
Lovelace Scientific Resources
🇺🇸Las Vegas, Nevada, United States
Radiant Research
🇺🇸Portland, Oregon, United States