Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
156
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2002
Shorter than P25 for phase_2
33 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
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 3, 2002
CompletedFirst Posted
Study publicly available on registry
September 5, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFebruary 20, 2015
January 1, 2015
9 months
September 3, 2002
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 (Day 1) to study termination (Day 28)
Baseline (Day 1) to Day 28
Secondary Outcomes (3)
Change in HbA1c from Baseline to Day 14
Baseline, Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
Baseline, Day 14, Day28
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
Baseline, Day 14, Day 28
Study Arms (8)
Placebo 0.01 mL
PLACEBO COMPARATOR2 week placebo lead-in followed by Placebo 0.01 mL
Placebo 0.02 mL
PLACEBO COMPARATOR2 week placebo lead-in followed by Placebo 0.02 mL
Placebo 0.03 mL
PLACEBO COMPARATOR2 week placebo lead-in followed by Placebo 0.03 mL
Placebo 0.04 mL
PLACEBO COMPARATOR2 week placebo lead-in followed by Placebo 0.04 mL
AC2993 2.5 mcg
EXPERIMENTAL2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
AC2993 5.0 mcg
EXPERIMENTAL2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
AC2993 7.5 mcg
EXPERIMENTAL2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
AC2993 10.0 mcg
EXPERIMENTAL2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
Interventions
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
Eligibility Criteria
You may qualify if:
- 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 %
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (33)
Innovative Clinical Trials
Birmingham, Alabama, 35209, United States
Healthsouth Clinical Research
Birmingham, Alabama, 35243, United States
Endocrinology Clinic of O.C.
Anaheim, California, 92801, United States
Pioneer Medical Group
Bellflower, California, 90706, United States
International Clinical Research Network
Chula Vista, California, 91910, United States
Bautista Research and Medical Clinic
Fresno, California, 93721, United States
Whittier Institute for Diabetes
La Jolla, California, 92037, United States
Richard Cherlin, M.D.
Los Gatos, California, 95032, United States
Dr. Martinez Medical Clinic
Moreno Valley, California, 92553, United States
Anshutz Outpatient Pavilion
Aurora, Colorado, 80010, United States
Diagnostic Clinic
Clearwater, Florida, 33760, United States
Radiant Research-Gainsville
Gainsville, Florida, 32605, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Radiant Research-Pinellas Park
Pinellas Park, Florida, 33781, United States
Clinical Research Group of North Georgia
Blairsville, Georgia, 30512, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96813, United States
Radiant Research-Honolulu
Honolulu, Hawaii, 96814, United States
Radiant Research-Boise
Boise, Idaho, 83704, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Northshore Medical Research, LLC
Covington, Louisiana, 70433, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
Melvin Kramer, MD
Concord, Massachusetts, 01742, United States
Radiant Research-Edina
Edina, Minnesota, 55435, United States
Mississippi Medical Research, LLC
Gulfport, Mississippi, 39501, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Innovative Health Research
Las Vegas, Nevada, 89119, United States
Carolina Advanced Research
Cary, North Carolina, 27511, United States
Fallen Timbers Internal Medicine, LLC
Maumee, Ohio, 43537, United States
Millenium Research
Benbrook, Texas, 76126, United States
Healthsouth Clinical Research
DeSoto, Texas, 75115, United States
Baylor College of Medicine/Clinical Studies Unit
Houston, Texas, 77030, United States
Diabetes Center of the Southwest
Midland, Texas, 79705, United States
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, 84108, 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
September 3, 2002
First Posted
September 5, 2002
Study Start
August 1, 2002
Primary Completion
May 1, 2003
Study Completion
May 1, 2003
Last Updated
February 20, 2015
Record last verified: 2015-01