This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
292
Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks
Glimepiride tablet orally up to 6 mg daily for 30 Weeks
Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).
Time frame: Baseline and Week 30
Number of Participants Who Experienced at Least One Adverse Event (AE)
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Time frame: Up to 32 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Time frame: Up to 30 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).
Time frame: Baseline and Week 30
Percentage of Participants With One or More Episodes of Hypoglycemia
Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.
Time frame: Up to Week 30
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Matching placebo to glimepiride tablet orally daily for 30 weeks
Change From Baseline in Body Weight at Week 30
Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)
Time frame: Baseline and Week 30
Percentage of Participants With HbA1C < 7.0% at Week 30
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
Time frame: Week 30