A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
555
Patients whose FPG \>240 mg/dL from Week 16 or HbA1C \>8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently \>240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C \>8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C \>7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.
Change from Baseline in HbA1C at Week 12
Time frame: Baseline and Week 12
Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14
Time frame: Up to Week 14
Number of Participants Who Experienced One or More AE up to Week 54
Time frame: Up to Week 54
Number of Participants Who Experienced One or More AE up to Week 108
Time frame: Up to Week 108
Number of Participants Who Experienced One or More AE up to Week 160
Time frame: Up to Week 160
Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12
Time frame: Up to Week 12
Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52
Time frame: Up to Week 52
Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106
Time frame: Up to Week 106
Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158
Time frame: Up to Week 158
Change from Baseline in HbA1C at Week 52
Time frame: Baseline and Week 52
Change from Baseline in HbA1C at Week 106
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Time frame: Baseline and Week 106
Change from Baseline in HbA1C at Week 158
Time frame: Baseline and Week 158
Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame: Baseline and Week 12
Change from Baseline in FPG at Week 52
Time frame: Baseline and Week 52
Change from Baseline in FPG at Week 106
Time frame: Baseline and Week 106
Change from Baseline in FPG at Week 158
Time frame: Baseline and Week 158
Change from Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Body Weight at Week 106
Time frame: Baseline and Week 106
Change from Baseline in Body Weight at Week 158
Time frame: Baseline and Week 158
Change From Baseline in Serum Fructosamine at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52
Time frame: Baseline and Week 52