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For your appropriate adult patients with type 2 diabetes, in addition to diet and exercise

HEAD-TO-HEAD DATA

Demonstrated A1C reductions comparable to a sulfonylurea with lower rates of hypoglycemia1


SIMILAR A1C REDUCTIONS AT WEEK 521,2

Saxagliptin 5 mg + metformin IR vs up-titrated glipizide + metformin IR in adults with type 2 diabetes1,2,a

Adjusted mean change in A1C from baseline, Saxagliptin 5 mg + metformin IR (-0.6%), Up-titrated gliptizide + metformin IR (-0.7%)
Adjusted mean change in A1C from baseline, Saxagliptin 5 mg + metformin IR (-0.6%), Up-titrated gliptizide + metformin IR (-0.7%)

95% Cl: -0.02, 0.2

aIn this study, saxagliptin 5 mg and metformin IR were administered as separate tablets.

  • Primary end point: Saxagliptin + metformin IR was considered non-inferior to glipizide + metformin IR—upper limit of this confidence interval less than prespecified non-inferiority margin of 0.35%1,2
  • A conclusion of non-inferiority of saxagliptin + metformin IR to glipizide + metformin IR may be limited to patients with baseline A1C comparable with those in the trial (91% of patients had baseline A1C <9.0%)1,2
  • A total of 65 (15.3%) patients in the saxagliptin + metformin IR group and 51 (12.0%) patients in the glipizide + metformin IR group discontinued the study due to lack of efficacy by Week 522
  • Patients eligible for the study were receiving ≥1500 mg metformin IR (mean metformin dose for overall study population was 1910 mg per day)1

Important Safety Information

Adverse Reactions

  • Adverse reactions reported in >5% of patients treated with metformin extended-release and more commonly than in patients treated with placebo were: diarrhea (9.6% vs 2.6%) and nausea/vomiting (6.5% vs 1.5%).
  • Adverse reactions reported in ≥5% of patients treated with saxagliptin and more commonly than in patients treated with placebo were: upper respiratory tract infection (7.7% vs 7.6%), urinary tract infection (6.8% vs 6.1%), and headache (6.5% vs 5.9%).


FEWER HYPOGLYCEMIC EVENTS OVER 52 WEEKS1

Saxagliptin 5 mg + metformin IR vs up-titrated glipizide + metformin IR in adults with type 2 diabetes1

Head to head comparator chart: fewer hypoglycemic events over 52 weeks. Reported Hypoglycemia: Saxagliptin 5 mg + metformin IR (3.0%), Up-titrated gliptizide + metformin IR 36.3%). Confirmed hypoglycemia: Saxagliptin 5 mg + metformin IR (0%), Up-titrated gliptizide + metformin IR (8.1%)
Head to head comparator chart: fewer hypoglycemic events over 52 weeks. Reported Hypoglycemia: Saxagliptin 5 mg + metformin IR (3.0%), Up-titrated gliptizide + metformin IR 36.3%). Confirmed hypoglycemia: Saxagliptin 5 mg + metformin IR (0%), Up-titrated gliptizide + metformin IR (8.1%)

P<0.0001 vs up-titrated glipizide + metformin IR.

In this study, saxagliptin 5 mg and metformin IR were administered as separate tablets.

Similar A1C reductions with fewer hypoglycemic events

  • 13 patients in the saxagliptin 5 mg + metformin IR group reported hypoglycemic events vs 156 patients in the up-titrated glipizide + metformin IR group. These patients had an average of 1.5 and 4.8 events, respectively.1*
  • Zero patients in the saxagliptin 5 mg + metformin IR group had a confirmed hypoglycemic event vs 35 patients in the up-titrated glipizide + metformin IR group1†

*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 reflect true hypoglycemia.

Based on accompanying fingerstick blood glucose ≤50 mg/dL.

Important Safety Information

Adverse Reactions

  • Confirmed hypoglycemia was reported more commonly in patients treated with saxagliptin 5 mg compared to placebo in the add-on to insulin (with or without metformin) trial (5.3% and 3.3%, respectively). Among the patients using insulin with metformin, the incidence of confirmed hypoglycemia was 4.8% with saxagliptin vs 1.9% with placebo. Confirmed hypoglycemia was reported more commonly with saxagliptin 5 mg compared to placebo in the add-on to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively).


STUDY DESIGN1,2

Head-to-Head Data

Randomized, 52-week, phase 3b, international, multicenter, parallel-group, active-controlled, double-blind, non-inferiority study with a 52-week extension period

A1C >6.5% and ≤10.0%

Head to head comparator A1C >6.5% and ≤10.0%. Patients assigned to Saxagliptin + metformin remained on Saxagliptin 5 mg throughout the study. Saxagliptin 5 mg + metformin (n=428), Glipizide 5-20 mg + metformin (n=430)
Head to head comparator A1C >6.5% and ≤10.0%. Patients assigned to Saxagliptin + metformin remained on Saxagliptin 5 mg throughout the study. Saxagliptin 5 mg + metformin (n=428), Glipizide 5-20 mg + metformin (n=430)

For patients assigned to glipizide + metformin, glipizide was titrated to an optimal effect [fasting plasma glucose (FPG) ≤110 mg/dL (≤6.1 mmol/L)] or the highest tolerated dose during an 18-week titration period. Glipizide was initiated at 5 mg/day (morning dose) and titrated in 3-week intervals to a maximum of 20 mg/day.

Study Objective

Evaluate the efficacy and safety of saxagliptin vs a sulfonylurea (SU), glipizide, as an add-on therapy to metformin in patients with inadequate glycemic control on a stable dose of metformin alone.

Primary Efficacy End Point

A1C change from baseline at 52 weeks

Secondary End Points Included

  • Proportion of patients reporting ≥1 hypoglycemic event over 52 weeks
  • Change from baseline body weight at Week 52

Study Length

52 weeks

Study Length

52 weeks

 

Key Inclusion Criteria

Key Inclusion Criteria

Demographic: Men and women age ≥18 years

Diagnosis: T2DM

A1C: >6.5% and ≤10.0%

Metformin Dose: Stable monotherapy ≥1500 mg/day for at least 8 weeks prior to enrollment

 

Study Dosing

Study Dosing

All patients received open-label metformin at 1500, 2000, 2500 or 3000 mg daily based on individual metformin dose at enrollment for the duration of the study; the dose remained stable throughout the study.

Primary Efficacy End Point

A1C change from baseline at 52 weeks

Secondary End Points Included

  • Proportion of patients reporting ≥1 hypoglycemic event over 52 weeks
  • Change from baseline body weight at Week 52

Primary Efficacy End Point

A1C change from baseline at 52 weeks

Secondary End Points Included

  • Proportion of patients reporting ≥1 hypoglycemic event over 52 weeks
  • Change from baseline body weight at Week 52