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

ADD-ON COMBINATION THERAPY


SIGNIFICANT A1C REDUCTIONS1,2

Saxagliptin 5 mg + metformin IR provided statistically significant reductions in A1C levels vs placebo + metformin IR at 6 months1,2,a,b

Saxagliptin 5 mg + metformin IR(-0.7%) provided statistically significant A1C reductions vs placebo + metformin IR (+0.1%) at 6 months
-0.8%

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

GREATER REDUCTION WITH SAXAGLIPTIN 5 MG + METFORMIN IR

Saxagliptin 5 mg + metformin IR(-0.7%) provided statistically significant A1C reductions vs placebo + metformin IR (+0.1%) at 6 months

GREATER REDUCTION WITH SAXAGLIPTIN 5 MG + METFORMIN IR

-0.8%

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

P<0.0001 vs placebo + metformin IR.

aIn these studies, saxagliptin 5 mg and metformin IR were administered as separate tablets.

bIntent-to-treat population using last observation on study or last observation prior to pioglitazone rescue therapy for patients needing rescue.

Uncontrolled on Metformin Monotherapy

  • A1C reduction with saxagliptin 2.5 mg when added to metformin IR was -0.6% (P<0.0001 vs metformin IR + placebo, n=186, baseline 8.1%) at 6 months1,2
  • The proportion of patients who discontinued or who were rescued in the saxagliptin 2.5 mg + metformin IR, saxagliptin 5 mg + metformin IR, and placebo + metformin groups was 15%, 13%, and 27%, respectively1


SIGNIFICANTLY REDUCED FPG AND PPG AT 6 MONTHS1,2

Saxagliptin 5 mg + metformin IR delivered statistically significant reductions in fasting plasma glucose (FPG) and postprandial glucose (PPG) vs placebo + metformin IR at 6 months1,2,c,d

FPG: Saxagliptin 5 mg + metformin IR (-22mg/dL) vs uptitrated glipizide + metformin IR (+1 mg/dL) 2 hour PPG: Saxagliptin 5 mg + metformin IR (-58 mg/dL) vs uptitrated glipizide + metformin IR (-18 mg/dL)

GREATER REDUCTIONS WITH SAXAGLIPTIN 5 MG + METFORMIN IR

FPG

-23 mg/dL

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

FPG: Saxagliptin 5 mg + metformin IR (-22mg/dL) vs uptitrated glipizide + metformin IR (+1 mg/dL) 2 hour PPG: Saxagliptin 5 mg + metformin IR (-58 mg/dL) vs uptitrated glipizide + metformin IR (-18 mg/dL)

GREATER REDUCTIONS WITH SAXAGLIPTIN 5 MG + METFORMIN IR

2-HOUR PPG

-40 mg/dL

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

FPG: Saxagliptin 5 mg + metformin IR (-22mg/dL) vs uptitrated glipizide + metformin IR (+1 mg/dL) 2 hour PPG: Saxagliptin 5 mg + metformin IR (-58 mg/dL) vs uptitrated glipizide + metformin IR (-18 mg/dL)
GREATER REDUCTIONS WITH SAXAGLIPTIN 5 MG + METFORMIN IR

FPG

-23 mg/dL

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

2-HOUR PPG

-40 mg/dL

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

P<0.05 vs placebo + metformin IR.

cIn these studies, saxagliptin 5 mg and metformin IR were administered as separate tablets.

dIntent-to-treat population using last observation on study or last observation  prior to pioglitazone rescue therapy for patients needing rescue.

  • Reductions with saxagliptin 2.5 mg + metformin IR were: FPG -14 mg/dL (P<0.05 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


STUDY DESIGN1,2

Add-on Combination Therapy

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

A1C ≥7.0% and ≤10.0% (n=743)

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)
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 saxagliptin, 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
  • Percent of patients achieving A1C <7.0%
  • PPG change from baseline following an oral glucose tolerance test at 6 months

Study Length

6 months

Study Length

6 months

 

Key Inclusion Criteria

Key Inclusion Criteria

Demographic: Men and women age 18–77 years

Diagnosis: Type 2 diabetes mellitus (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

Study Dosing

After the lead-in period, eligible patients were randomly assigned 1:1:1:1 (permuted blocks stratified by site) by an interactive voice response system to 2.5, 5, or 10 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
  • Percent of patients achieving A1C <7.0%
  • PPG change from baseline following an oral glucose tolerance test at 6 months

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary and Other Efficacy End Points

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