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

ONGLYZA HEAD-TO-HEAD VS A SULFONYLUREA

Demonstrated reductions in A1C levels comparable to glipizide with lower rates of hypoglycemia1,2

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SIMILAR A1C REDUCTIONS AT WEEK 521,2

ONGLYZA 5 mg + metformin IR vs up-titrated glipizide + metformin IR in adults with type 2 diabetes mellitus1,2

Adjusted mean change in A1C from baseline(%)

A1C reductions at week 52 ONGLYZA® (saxagliptin) 5 mg + metformin IR vs up-titrated glipizide + metformin IR in adults with type 2 diabetes
A1C reductions at week 52 ONGLYZA® (saxagliptin) 5 mg + metformin IR vs up-titrated glipizide + metformin IR in adults with type 2 diabetes

95% CI: -0.02, 0.2.

  • Mean dose of metformin in the ONGLYZA 5-mg arm was 1938 mg and 1883 mg in the up-titrated glipizide arm2
  • A conclusion of non-inferiority of ONGLYZA 5 mg + metformin IR to up-titrated glipizide + metformin IR may be limited to patients with baseline A1C levels comparable to those in the trial (91% of patients had baseline A1C levels <9.0%)1,2
  • The upper limit of the 95% confidence interval met the predefined criterion for non-inferiority of <0.35%. Thus, ONGLYZA 5 mg + metformin IR was non-inferior to up-titrated glipizide + metformin IR1,2
  • A total of 65 (15.3%) subjects in the ONGLYZA 5 mg + metformin IR group and 51 (12.0%) subjects in the up-titrated glipizide + metformin IR group discontinued the study due to lack of efficacy by Week 523
  • Most common adverse reactions reported in ≥5% of patients treated with ONGLYZA and more commonly than in patients treated with placebo were upper respiratory tract infection (7.7%, 7.6%), urinary tract infection (6.8%, 6.1%), and headache (6.5%, 5.9%)


 

FEWER HYPOGLYCEMIC EVENTS OVER 52 WEEKS1,2

ONGLYZA 5 mg + metformin IR vs up-titrated glipizide + metformin IR in adults with type 2 diabetes mellitus1,2

Percentage of Patients (%)

Fewer confirmed hypoglycemic patient events for  ONGLYZA 5 mg + metformin IR group vs up-titrated glipizide + metformin IR
Fewer confirmed hypoglycemic patient events for  ONGLYZA 5 mg + metformin IR group vs up-titrated glipizide + metformin IR
P<0.0001 vs up-titrated glipizide + metformin IR.
  • 13 patients in the ONGLYZA 5 mg + metformin IR group reported 19 hypoglycemic events vs 156 patients in the up-titrated glipizide + metformin IR group who reported 750 hypoglycemic events. These patients had an average of 1.5 and 4.8 events, respectively1,2,*
  • Zero patients in the ONGLYZA 5 mg + metformin IR group had a confirmed hypoglycemic event vs 35 patients in the up-titrated glipizide + metformin IR group1,2,†
  • Confirmed hypoglycemia was reported more commonly in patients treated with ONGLYZA 2.5 mg and ONGLYZA 5 mg compared to placebo in the add-on to glyburide trial (2.4%, 0.8%, and 0.7%, respectively), with ONGLYZA 5 mg compared to placebo in the add-on to insulin (with or without metformin) trial (5.3% and 3.3%, respectively), with ONGLYZA 2.5 mg compared to placebo in the renal impairment trial (4.7% and 3.5%, respectively), and with ONGLYZA 5 mg compared to placebo in the add-on to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively)

*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. Confirmed hypoglycemia was defined as a fingerstick glucose ≤50 mg/dL with associated symptoms.

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 Head-to-Head vs a Sulfonylurea

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%

PATIENTS ASSIGNED TO SAXAGLIPTIN + METFORMIN REMAINED ON SAXAGLIPTIN 5 MG THROUGHOUT THE STUDY

Patient profile A1C > 6.5% and <10.0% Randomization: Saxagliptin 5 mg + metformin (n=428), Glipizide 5-20 mg + metformin (n=430)
Patient profile A1C > 6.5% and <10.0% Randomization: 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 ONGLYZA 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

Key Secondary End Points

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

Other Secondary End Points

  • Change from baseline FPG
  • Fasting insulin
  • C-peptide, glucagon, and proinsulin
  • Proportion of patients achieving a therapeutic glycemic response defined as A1C ≤6.5% in patients with baseline A1C ≥7%
  • Proportion of patients achieving a therapeutic glycemic response defined as A1C <7% in patients with baseline A1C ≥7%

Study Length

52 weeks

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

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. Patients assigned to saxagliptin plus metformin remained on saxagliptin 5 mg throughout the study.

Primary Efficacy End Point

A1C change from baseline at 52 weeks

Key Secondary End Points

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

Other Secondary End Points

  • Change from baseline FPG
  • Fasting insulin
  • C-peptide, glucagon, and proinsulin
  • Proportion of patients achieving a therapeutic glycemic response defined as A1C ≤6.5% in patients with baseline A1C ≥7%
  • Proportion of patients achieving a therapeutic glycemic response defined as A1C <7% in patients with baseline A1C ≥7%