The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,736
Adjusted Mean Change From Baseline in HbA1c
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.
Time frame: Baseline and Week 24
Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.
Time frame: Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)
Mean Change in Fasting Plasma Glucose (FPG)
The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG \> 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter
Time frame: Baseline and Week 24
Mean Change in Mean Daily Glucose (MDG)
The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.
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Central Alabama Research
Birmingham, Alabama, United States
Terence T. Hart, Md
Muscle Shoals, Alabama, United States
Clini Res Advantage Desert Clin Res, Llc
Mesa, Arizona, United States
Clinical Res Advantage Central
Phoenix, Arkansas, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Actca
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
R. Srinivasan, M.D., Inc.
Monterey Park, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
...and 146 more locations
Time frame: Baseline and Week 24
Percent of Participants With HbA1c < 7%
Percent of participants achieving a therapeutic glycemic response (defined as HbA1c \< 7.0%) at Week 24 in the double-blind treatment period.
Time frame: Week 24