A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE
Demonstrated significant reductions in A1C levels with similar rates of hypoglycemia1
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P<0.01 compared to placebo.
aIntent-to-treat population using last observation on study.
Start your renally impaired (moderate to severe, or ESRD requiring hemodialysis [eGFR <45mL/min/1.73 m2]) patients on ONGLYZA 2.5 mg. No dose adjustment needed for mild renal impairment (eGFR ≥45mL/min/1.73 m2).1
*Reported hypoglycemic events were a combination of reports of either signs or symptoms consistent with hypoglycemia with or without documented glucose levels or reported low glucose levels without any symptoms. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is not possible to conclusively determine that all these reports reflected true hypoglycemia.
†Confirmed hypoglycemia was defined as a fingerstick glucose ≤50 mg/dL with associated symptoms.
There were no clinically meaningful changes in renal function as assessed by estimated glomerular filtration rate (eGFR), creatinine, and proteinuria from baseline to Week 12 in patients treated with ONGLYZA 2.5 mg or placebo.2
No patients had a doubling of serum creatinine, and no patients progressed to end-stage renal disease (ESRD).2
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 3b, 12-week, multicenter, multinational, randomized, double-blind, placebo-controlled study
‡Oral antihyperglycemic drugs and/or insulin therapy present at enrollment were continued throughout the study; discontinuation or down-titration of these medications was allowed only if needed to prevent hypoglycemia.
Study Objective
This study evaluated the efficacy and safety of ONGLYZA vs placebo in patients with type 2 diabetes mellitus and renal impairment (moderate, severe, or ESRD).
Degree of Renal Impairment
Primary Efficacy End Point
A1C change from baseline at 12 weeks
Secondary Efficacy End Point
Fasting plasma glucose change from baseline at 12 weeks
12 weeks, with an additional 40-week observational period
Demographic: Men and women age ≥18 years
Diagnosis: T2DM
A1C: ≥7.0% and ≤11.0%
CrCl: <50 mL/min within the previous 3 months
C-peptide: ≥0.33 nmol/L
Degree of Renal Impairment
Primary Efficacy End Point
A1C change from baseline to Week 12
Secondary Efficacy End Point
Fasting plasma glucose change from baseline at 12 weeks