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 medications (metformin and a sulfonylurea) throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
734
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 / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Change in HbA1c from Baseline to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Time frame: Baseline (Day 1) to 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
Change in body weight from Baseline to each intermediate visit and Week 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, United States
Southern Drug Research Network
Tallassee, Alabama, United States
First Care Family Doctors
Fayetteville, Arkansas, United States
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
East Bay Clinical Trial Center
Concord, California, United States
Medical Group of Encino
Encino, California, United States
Valley Research
Fresno, California, United States
...and 90 more locations
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