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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085969
• Other study ID #: 2993-120
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2004
• Last updated: February 19, 2015
• Start date: September 2003
• Est. completion date: January 2004

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo 0.04 mL twice daily
Subcutaneously injected, 0.04 mL, twice daily
• Placebo 0.04 mL once daily
Subcutaneously injected, 0.04 mL, once daily
• Placebo 0.08 mL once daily
Subcutaneously injected, 0.08 mL, once daily
• B - Exenatide 10 mcg twice daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
• C - Exenatide 10 mcg once daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
• Exenatide 20 mcg once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28	Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)	Baseline, Day 28	No
Secondary	Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28	Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)	Baseline, Day 14, Day 28	No
Secondary	Change in body weight from Baseline to Day 14 and to Day 28	Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)	Baseline, Day 14, Day28	No
Secondary	Change in fasting plasma glucose concentration from Baseline to Day 14 and to 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)	Baseline, Day 14, Day 28	No
Secondary	Change in postprandial blood glucose concentrations from Baseline to Day 28	Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)	Baseline, Week 28	No