Clinical trial NCT00085969: Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
exenatide
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2004-06-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
timeFrame: Baseline, Day 28
Secondary outcomes:
measure: Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28
timeFrame: Baseline, Day 14, Day 28
measure: Change in body weight from Baseline to Day 14 and to Day 28
timeFrame: Baseline, Day 14, Day28
measure: Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28
timeFrame: Baseline, Day 14, Day 28
measure: Change in postprandial blood glucose concentrations from Baseline to Day 28
timeFrame: Baseline, Week 28
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Whittier Institute for Diabetes
state: California
city: San Diego
country: United States
facility: VA Medical Center
state: California
city: Washington
country: United States
facility: MedStar Research Institute
state: District of Columbia
city: Fort Myers
country: United States
facility: Internal Medicine Associates, Department of Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Associated Internists
state: Michigan
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Bozeman
country: United States
facility: Internal Medicine Associates
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Marion
country: United States
facility: Smith Clinic Research
state: Ohio
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Health Associates - Adult Medicine
state: Pennsylvania
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Research Associates
state: Texas
city: San Antonio
country: United States
facility: S.A.M. Clinical Research Center
state: Texas
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
Study officials:
References:
citation: 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.