Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
99
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Sep 2003
Shorter than P25 for phase_2 diabetes-mellitus-type-2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 18, 2004
CompletedFirst Posted
Study publicly available on registry
June 22, 2004
CompletedFebruary 23, 2015
January 1, 2015
4 months
June 18, 2004
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day 28
Change in body weight from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day28
Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day 28
Change in postprandial blood glucose concentrations from Baseline to Day 28
Baseline, Week 28
Study Arms (6)
A1 - Placebo 0.04 mL twice daily
PLACEBO COMPARATORA2 - Placebo 0.04 mL once daily
PLACEBO COMPARATORA3 - Placebo 0.08 mL once daily
PLACEBO COMPARATORB - Exenatide 10 mcg twice daily
EXPERIMENTALC - Exenatide 10 mcg once daily
EXPERIMENTALD - Exenatide 20 mcg once daily
EXPERIMENTALInterventions
Subcutaneously injected, 0.04 mL, twice daily
Subcutaneously injected, 0.04 mL, once daily
Subcutaneously injected, 0.08 mL, once daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (23)
The Whittier Institute for Diabetes
La Jolla, California, 92037, United States
VA Medical Center
San Diego, California, 92161, United States
MedStar Research Institute
Washington D.C., District of Columbia, 20003, United States
Internal Medicine Associates, Department of Research
Fort Myers, Florida, 33901, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Innovative Research of West Florida
Largo, Florida, 33770, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Grand Rapids Associated Internists
Grand Rapids, Michigan, 49506, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Internal Medicine Associates
Bozeman, Montana, 59715, United States
Mercury Street Medical Group
Butte, Montana, 59701, United States
Lovelace Scientific Resources
Las Vegas, Nevada, 89128, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Columbus, Ohio, 43212, United States
Smith Clinic Research
Marion, Ohio, 43302, United States
Radiant Research
Portland, Oregon, 97239, United States
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, 19146, United States
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229-4801, United States
S.A.M. Clinical Research Center
San Antonio, Texas, 78229, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Rockwood Clinic
Spokane, Washington, 99202, United States
Related Publications (1)
Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.
PMID: 17705687DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2004
First Posted
June 22, 2004
Study Start
September 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
February 23, 2015
Record last verified: 2015-01