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FOR YOUR APPROPRIATE ADULT PATIENTS WITH TYPE 2 DIABETES, IN ADDITION TO DIET AND EXERCISE

ONGLYZA AS ADD-ON THERAPY

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SIGNIFICANT A1C REDUCTIONS WHEN ADDED TO METFORMIN IR1

ONGLYZA® (saxagliptin) provided statistically significant A1C reductions when added to metformin IR vs placebo + metformin IR at 6 months1,2,a

Mean change from baseline (%)

A1C reductions reported- ONGLYZA 5 mg + metformin IR= -0.7% vs placebo +metformin IR=+0.1%
GREATER REDUCTION WHEN ONGLYZA 5 MG ADDED VS PLACEBO
-0.8%

(95% Cl: -1.0%, -0.6%)

A1C reductions reported- ONGLYZA 5 mg + metformin IR= -0.7% vs placebo +metformin IR=+0.1%
-0.8%

(95% Cl: -1.0%, -0.6%)

GREATER REDUCTION WHEN ONGLYZA 5 MG ADDED VS PLACEBO + METFORMIN IR

P<0.0001 vs placebo + metformin IR.

aIntent-to-treat population using last observation on study prior to pioglitazone rescue therapy.

  • Reductions with ONGLYZA 2.5 mg + metformin IR were A1C, -0.6% (P<0.0001 vs placebo + metformin IR; n=186; baseline A1C, 8.1%) after 6 months1,2


SIGNIFICANTLY REDUCED FPG AND PPG AT 6 MONTHS1,2

ONGLYZA added to metformin IR delivered statistically significant reductions in FPG and PPG vs placebo + metformin IR at 6 months1,2,b

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
GREATER REDUCTION WHEN ONGLYZA 5 MG ADDED VS PLACEBO + METFORMIN IR
-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
GREATER REDUCTION WHEN ONGLYZA 5 MG ADDED VS PLACEBO + METFORMIN IR
-23 mg/dL

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

-40 mg/dL

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

GREATER REDUCTION WHEN ONGLYZA 5 MG ADDED VS PLACEBO + METFORMIN IR
-40 mg/dL

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

P<0.05 vs placebo + metformin IR.

bIntent-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 (P<.05 vs placebo + metformin IR; n=188; baseline FPG, 174 mg/dL), and PPG, -62 mg/dL (P<0.05 vs placebo + metformin IR; n=155; baseline PPG, 294 mg/dL) at 6 months1,2

 

Select Important Safety Information

Warnings and Precautions

  • Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin: When ONGLYZA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of confirmed hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia when used in combination with ONGLYZA.
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.


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