Clinical trial NCT00044694: Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
Official title: A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-09-05
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
* BMI 27-45 kg/m\^2
* HbA1c between 7.0 % and 8.0 %

Exclusion Criteria:

* Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
* Patients previously treated with AC2993
* Patients presently treated with insulin

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
timeFrame: Baseline (Day 1) to Day 28
Secondary outcomes:
measure: Change in HbA1c from Baseline to Day 14
timeFrame: Baseline, Day 14
measure: Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
timeFrame: Baseline, Day 14, Day28
measure: Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
timeFrame: Baseline, Day 14, Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Innovative Clinical Trials
state: Alabama
city: Birmingham
country: United States
facility: Healthsouth Clinical Research
state: Alabama
city: Anaheim
country: United States
facility: Endocrinology Clinic of O.C.
state: California
city: Bellflower
country: United States
facility: Pioneer Medical Group
state: California
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Fresno
country: United States
facility: Bautista Research and Medical Clinic
state: California
city: La Jolla
country: United States
facility: Whittier Institute for Diabetes
state: California
city: Los Gatos
country: United States
facility: Richard Cherlin, M.D.
state: California
city: Moreno Valley
country: United States
facility: Dr. Martinez Medical Clinic
state: California
city: Aurora
country: United States
facility: Anshutz Outpatient Pavilion
state: Colorado
city: Clearwater
country: United States
facility: Diagnostic Clinic
state: Florida
city: Gainsville
country: United States
facility: Radiant Research-Gainsville
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research-Pinellas Park
state: Florida
city: Blairsville
country: United States
facility: Clinical Research Group of North Georgia
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Honolulu
country: United States
facility: Radiant Research-Honolulu
state: Hawaii
city: Boise
country: United States
facility: Radiant Research-Boise
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Covington
country: United States
facility: Northshore Medical Research, LLC
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Concord
country: United States
facility: Melvin Kramer, MD
state: Massachusetts
city: Edina
country: United States
facility: Radiant Research-Edina
state: Minnesota
city: Gulfport
country: United States
facility: Mississippi Medical Research, LLC
state: Mississippi
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Cary
country: United States
facility: Carolina Advanced Research
state: North Carolina
city: Maumee
country: United States
facility: Fallen Timbers Internal Medicine, LLC
state: Ohio
city: Benbrook
country: United States
facility: Millenium Research
state: Texas
city: Desoto
country: United States
facility: Healthsouth Clinical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Clinical Studies Unit
state: Texas
city: Midland
country: United States
facility: Diabetes Center of the Southwest
state: Texas
city: Salt Lake City
country: United States
facility: Utah Diabetes Center at the University of Utah
state: Utah
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.