A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE
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P<0.0001 vs metformin IR + placebo.
aIntent-to-treat population using last observation on study prior to pioglitazone rescue therapy.
P<0.05 compared to metformin IR + placebo
(95% Cl: -19 mg/dL, -6 mg/dL)
(95% Cl: -57 mg/dL, -25 mg/dL)
P<0.05 vs metformin IR + placebo.
bIntent-to-treat population using last observation on study prior to pioglitazone rescue therapy.
(95% Cl: -19 mg/dL, -6 mg/dL)
(95% Cl: -57 mg/dL, -25 mg/dL)
Phase 3, multicenter, international, randomized, double-blind, active-controlled study
*Metformin IR dose was between 1000 and 2000 mg daily. Metformin IR was initiated at a starting dose of 500 mg daily, up-titrated to 1000 mg at Week 1, and thereafter up-titrated as tolerated to a maximum of 2000 mg daily based on FPG through Week 5.
Evaluate the efficacy and safety of ONGLYZA as initial combination therapy with metformin IR compared with metformin IR monotherapy in medication-naive patients.
A1C change from baseline at 6 months
6 months
Demographic: Men and women age 18-77 years; patients had to be treatment-naive
Diagnosis: T2DM
A1C: ≥8.0% and ≤12.0%
Fasting C-peptide: ≥1.0 ng/mL
Body Mass Index: ≤40 kg/m2
*Metformin IR dose was between 1000 and 2000 mg daily. Metformin IR was initiated at a starting dose of 500 mg daily, up-titrated to 1000 mg at Week 1, and thereafter up-titrated as tolerated to a maximum of 2000 mg daily based on FPG through Week 5.
A1C change from baseline at 6 months