This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
336
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).
Time frame: Baseline (Day 1), Week 30
Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, and Week 24)
Time frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30)
Time frame: Baseline (Day 1) and Week 30
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30)
Time frame: Baseline (Day 1), and Week 30
The time to achieve specific HbA1c target values of < 7% and < 8%
The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8%
Time frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more
Time frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
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Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Pinnacle Research Group
Anniston, Alabama, United States
Parkway Medical Center
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Eclectic Family Care
Eclectic, Alabama, United States
Winston Physician Services
Haleyville, Alabama, United States
Simon Williamson Clinic
Hueytown, Alabama, United States
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, United States
Southern Drug Research Network
Tallassee, Alabama, United States
Clinic of Physicians and Surgeons, Ltd.
Mesa, Arizona, United States
ANA Ventures, LLC
Mesa, Arizona, United States
...and 119 more locations
Change in body weight from Baseline to each intermediate visit and Week 30
Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Time frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30