Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

Condition(s) targeted: Diabetes Mellitus, Non-Insulin-Dependent

Intervention: Placebo 0.01 mL (Drug); Placebo 0.02 mL (Drug); Placebo 0.03 mL (Drug); Placebo 0.04 mL (Drug); AC2993 2.5 mcg (Drug); AC2993 5.0 mcg (Drug); AC2993 7.5 mcg (Drug); AC2993 10.0 mcg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

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.

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

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28

Secondary outcome:

Change in HbA1c from Baseline to Day 14

Change in fasting plasma glucose from Baseline to Day 14 and to Day 28

Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Healthsouth Clinical Research, Birmingham, Alabama 35243, United States

Innovative Clinical Trials, Birmingham, Alabama 35209, 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

Starting date: August 2002
Last updated: February 19, 2015