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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
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
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
Time frame: Baseline (Day 1) to Day 28
Change in HbA1c from Baseline to Day 14
Change in HbA1c from Baseline (Day 1) to Day 14
Time frame: Baseline, Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
Time frame: Baseline, Day 14, Day28
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Time frame: Baseline, Day 14, Day 28
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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
Innovative Clinical Trials
Birmingham, Alabama, United States
Healthsouth Clinical Research
Birmingham, Alabama, United States
Endocrinology Clinic of O.C.
Anaheim, California, United States
Pioneer Medical Group
Bellflower, California, United States
International Clinical Research Network
Chula Vista, California, United States
Bautista Research and Medical Clinic
Fresno, California, United States
Whittier Institute for Diabetes
La Jolla, California, United States
Richard Cherlin, M.D.
Los Gatos, California, United States
Dr. Martinez Medical Clinic
Moreno Valley, California, United States
Anshutz Outpatient Pavilion
Aurora, Colorado, United States
...and 23 more locations