A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE
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P<0.0001.
aMean baseline A1C level was 8.1% for all groups.
bAdjusted mean change in A1C level from baseline.
Intent-to-treat population using last observation on study prior to pioglitazone rescue therapy for patients needing rescue.
*Mean baseline A1C level was 8.1% for all groups.
†Adjusted mean change in A1C level from baseline.
(95% Cl: -30 mg/dL, -16 mg/dL)
(95% Cl: -56 mg/dL, -24 mg/dL)
(95% Cl: -30 mg/dL, -16 mg/dL)
(95% Cl: -56 mg/dL, -24 mg/dL)
P<0.05 vs placebo + metformin IR.
cIntent-to-treat population using last observation on study prior to pioglitazone rescue therapy.
Hypoglycemia: When ONGLYZA was used in combination with a sulfonylurea or with insulin, the incidence of confirmed hypoglycemia was increased over that of placebo. Consider lowering the dose of these agents when coadministered with ONGLYZA.
Phase 3, 24-week, multicenter, randomized, double-blind, placebo-controlled study
*Metformin IR dose was between 1500 and 2500 mg daily.
Evaluate the efficacy and safety of ONGLYZA in addition to diet and exercise as add-on to metformin IR compared to placebo + metformin IR.
A1C change from baseline at 6 months
6 months
Demographic: Men and women age 18–77 years
Diagnosis: T2DM
A1C: ≥7.0% and ≤10.0%
Metformin Dose: Stable monotherapy ≥1500 mg/day but not >2550 mg/day for at least 8 weeks prior to enrollment
Fasting C-peptide: ≥1.0 ng/mL
Body Mass Index: ≤40 kg/m2
After the lead-in period, eligible patients were randomly assigned 5 mg saxagliptin or placebo for 24 weeks in addition to their lead-in dose of open-label metformin.
A1C change from baseline at 6 months