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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo 0.04 mL once daily; Drug: Exenatide 20 mcg once daily; Drug: Placebo 0.04 mL twice daily; Drug: Placebo 0.08 mL once daily; Drug: B - Exenatide 10 mcg twice daily; Drug: 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

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2004-06-18
• Study First Submitted QC: 2004-06-21
• Study First Posted: 2004-06-22
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• 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 Criteria

• 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)

The Whittier Institute for Diabetes; 🇺🇸 La Jolla, California, United States

VA Medical Center; 🇺🇸 San Diego, California, United States

MedStar Research Institute; 🇺🇸 Washington, 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

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