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A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE

ONGLYZA IN RENALLY IMPAIRED PATIENTS

Demonstrated significant reductions in A1C levels with similar rates of hypoglycemia1

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STATISTICALLY SIGNIFICANT REDUCTIONS IN A1C LEVELS AT WEEK 121

ONGLYZA 2.5 mg vs placebo1,a

Adjusted mean change in A1C from baseline (%)

ONGLYZA 2.5mg -0.9% vs Placebo -0.4% adjusted mean change in A1C from baseline
ONGLYZA 2.5mg -0.9% vs Placebo -0.4% adjusted mean change in A1C from baseline

P<0.01 compared to placebo.

aIntent-to-treat population using last observation on study.

Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter1

  • The difference in A1C values between the 2 arms is subject to rounding error and matches the presentation in the Prescribing Information. The A1C level change with ONGLYZA 2.5 mg was -0.86% and -0.44% for placebo1,2
  • In a subgroup of patients with end-stage renal disease (ESRD), ONGLYZA and placebo resulted in comparable reductions in A1C from baseline to Week 12. This finding is inconclusive because the trial was not adequately powered to show efficacy within the specific subgroups of renal impairment1
  • Nearly all patients (98%) were on a background therapy, including insulin (75%) and other oral antidiabetic medications (31%)1
  • The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with eGFR <45mL/min/1.73 m2 (which includes a subset of moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis). ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis

 

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


 

SIMILAR RATES OF HYPOGLYCEMIA OVER 12 WEEKS1,2

ONGLYZA 2.5 mg vs placebo in patients with renal impairment1,2

Proportion of Patients (%)

Hypoglycemia reported- ONGLYZA 2.5mg= 20.0% vs Placebo =22.0%, confirmed- ONGLYZA 2.5mg= 4.7% vs Placebo =3.5%
Hypoglycemia reported- ONGLYZA 2.5mg= 20.0% vs Placebo =22.0%, confirmed- ONGLYZA 2.5mg= 4.7% vs Placebo =3.5%
  • Hypoglycemia was reported in 17 (20%) ONGLYZA patients and 19 (22%) placebo patients1,2,*
  • Confirmed hypoglycemia was experienced by 4 (4.7%) ONGLYZA patients and 3 (3.5%) placebo patients1,2,†
  • Discontinuation due to adverse events was similar for ONGLYZA and placebo2

*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.


 

STUDY DESIGN1,2

ONGLYZA in Renally Impaired Patients

Phase 3b, 12-week, multicenter, multinational, randomized, double-blind, placebo-controlled study

Patient profile A1C > 7.0% and <11.0% Randomiation: ONGLYZA 2.5 mg vs Placebo
Patient profile A1C > 7.0% and <11.0% Randomiation: ONGLYZA 2.5 mg vs Placebo

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.

  • Adult patients with type 2 diabetes with moderate or severe renal impairment or ESRD

 

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

  • Moderate (n=90): CrCl ≥30 and <50 mL/min
  • Severe (n=41): CrCl <30 mL/min
  • ESRD on hemodialysis (n=39)

Primary Efficacy End Point

A1C change from baseline at 12 weeks

Secondary Efficacy End Point

Fasting plasma glucose change from baseline at 12 weeks

Study Length

12 weeks, with an additional 40-week observational period

Key Inclusion Criteria

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

 

Study Dosing

  • ONGLYZA 2.5 mg or placebo
  • Current oral antidiabetic or insulin therapy (continued throughout study)

Degree of Renal Impairment

  • Moderate (n=90): CrCl ≥30 and <50 mL/min
  • Severe (n=41): CrCl <30 mL/min
  • ESRD on hemodialysis (n=39)

Primary Efficacy End Point

A1C change from baseline to Week 12

Secondary Efficacy End Point

Fasting plasma glucose change from baseline at 12 weeks