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

ONGLYZA AS ADD-ON THERAPY

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MEANINGFUL A1C REDUCTIONS WHEN PATIENTS WERE UNCONTROLLED ON METFORMIN1,2

Significant difference in mean A1C reductions vs placebo at 24 weeks1,2,a,b

Mean change from baseline (%)

A1C reductions reported- ONGLYZA 5 mg + metformin IR= -0.7% vs placebo +metformin IR=+0.1%
MEAN DIFFERENCE IN A1C CHANGES FROM PLACEBO
0.8%
A1C reductions reported- ONGLYZA 5 mg + metformin IR= -0.7% vs placebo +metformin IR=+0.1%
0.8%
MEAN DIFFERENCE IN A1C CHANGES FROM PLACEBO

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.

  • Significant difference in mean A1C reductions with ONGLYZA 2.5 mg + metformin (n=186) vs placebo + metformin (n=175) at 24 weeks (-0.6% vs 0.1%, respectively; 0.7% difference from placebo; P<0.0001)1,2,*,†
  • “Uncontrolled” defined as A1C ≥7.0% and ≤10%
  • The proportion of patients who discontinued for lack of glycemic control or who were rescued for meeting prespecified glycemic criteria was 15% in the ONGLYZA 2.5 mg + metformin group, 13% in the ONGLYZA 5 mg + metformin group, and 27% in the placebo + metformin group

*Mean baseline A1C level was 8.1% for all groups.

Adjusted mean change in A1C level from baseline.


 

SIGNIFICANTLY REDUCED FPG AND PPG AT 6 MONTHS1,2

ONGLYZA added to metformin IR delivered statistically significant reductions in fasting plasma glucose (FPG) and postprandial glucose (PPG) vs placebo + metformin IR at 6 months1,2,c

Mean change from baseline(mg/dL)

Reductions with ONGLYZA 5 mg + metformin IR= -22mg/dl vs placebo + metformin IR=+1mg/dl and 2hrs PPG- ONGLYZA 5mg + metformin IR= -22mg/dl vs placebo + metformin IR= -18mg/dl
MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO
-23 mg/dL

(95% Cl: -30 mg/dL, -16 mg/dL)

Reductions with ONGLYZA 5 mg + metformin IR= -22mg/dl vs placebo + metformin IR=+1mg/dl and 2hrs PPG- ONGLYZA 5mg + metformin IR= -22mg/dl vs placebo + metformin IR= -18mg/dl
Reductions with ONGLYZA 5 mg + metformin IR= -22mg/dl vs placebo + metformin IR=+1mg/dl and 2hrs PPG- ONGLYZA 5mg + metformin IR= -22mg/dl vs placebo + metformin IR= -18mg/dl
MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO
-23 mg/dL

(95% Cl: -30 mg/dL, -16 mg/dL)

-40 mg/dL

(95% Cl: -56 mg/dL, -24 mg/dL)

MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO
-23 mg/dL

(95% Cl: -30 mg/dL, -16 mg/dL)

-40 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.

  • Reductions with ONGLYZA 2.5 mg + metformin IR were: FPG, -14 mg/dL (n=188; baseline FPG, 174 mg/dL) and PPG, -62 mg/dL (n=155; baseline PPG, 294 mg/dL) vs placebo + metformin IR at 6 months1,2

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 as Add-On Therapy

Phase 3, 24-week, multicenter, randomized, double-blind, placebo-controlled study

Patient profile A1C > 7.0% and < 10.0% (n=743) Randomization: Saxagliptin 5 mg + metformin IR (n=191), Saxagliptin 2.5 mg + metformin IR (n=192), Saxagliptin 10 mg + metformin IR (n=181), Placebo + metformin IR (n=179)
Patient profile A1C > 7.0% and < 10.0% (n=743) Randomization: Saxagliptin 5 mg + metformin IR (n=191), Saxagliptin 2.5 mg + metformin IR (n=192), Saxagliptin 10 mg + metformin IR (n=181), Placebo + metformin IR (n=179)

*Metformin IR dose was between 1500 and 2500 mg daily.

 

Study Objective

Evaluate the efficacy and safety of ONGLYZA in addition to diet and exercise as add-on to metformin IR compared to placebo + metformin IR.

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary and Other Efficacy End Points

  • FPG change from baseline at 6 months
  • Percentage of patients achieving A1C <7.0%
  • PPG change from baseline following an oral glucose tolerance test at 6 months

Study Length

6 months

Key Inclusion Criteria

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

 

Study Dosing

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.

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary and Other Efficacy End Points

  • FPG change from baseline at 6 months
  • Percentage of patients achieving A1C <7.0%
  • PPG change from baseline following an oral glucose tolerance test at 6 months