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

INITIAL COMBINATION THERAPY WITH ONGLYZA

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STATISTICALLY SIGNIFICANT A1C REDUCTIONS AT 6 MONTHS1,2

ONGLYZA 5 mg + metformin IR vs placebo + metformin IR in adults with type 2 diabetes mellitus uncontrolled on diet and exercise alone1,2,a

Mean change from baseline (%)

Initial combination therapy with metformin IR provided statistically significant A1C reductions vs metformin IR plus placebo at 6 months
Initial combination therapy with metformin IR provided statistically significant A1C reductions vs metformin IR plus placebo at 6 months

P<0.0001 vs metformin IR + placebo.

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

SIGNIFICANTLY MORE PATIENTS REACHED A1C <7%
60% vs 41%

P<0.05 compared to metformin IR + placebo

  • Incidence of reported hypoglycemia was 3.4% with ONGLYZA 5 mg + metformin IR vs 4.0% with metformin + placebo1,2
  • 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%)
  • The proportion of patients who discontinued due to lack of glycemic control or who were rescued for meeting prespecified glycemic criteria on metformin IR alone vs saxagliptin 5 mg + metformin IR was 10.1% vs 7.5%, respectively1

 


 

SIGNIFICANT REDUCTIONS IN FPG AND PPG1,2

ONGLYZA as initial combination therapy with metformin IR delivered statistically significant reductions in fasting plasma glucose (FPG) and postprandial glucose (PPG) vs placebo + metformin IR at 6 months1,2,b

Mean change from baseline(mg/dL)

Reductions in FPG reported ONGLYZA 5 mg + metformin IR=-60mg/dl vs metformin IR+ placebo= -47mg/dl with 2hr PPG= ONGLYZA 5 mg + metformin IR= -138mg/dl vs metformin IR+ Placebo= -97mg/dl
MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO
FPG
-13 mg/dL

(95% Cl: -19 mg/dL, -6 mg/dL)

Reductions in FPG reported ONGLYZA 5 mg + metformin IR=-60mg/dl vs metformin IR+ placebo= -47mg/dl with 2hr PPG= ONGLYZA 5 mg + metformin IR= -138mg/dl vs metformin IR+ Placebo= -97mg/dl
MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO
2-Hour PPG
-41 mg/dL

(95% Cl: -57 mg/dL, -25 mg/dL)

Reductions in FPG reported ONGLYZA 5 mg + metformin IR=-60mg/dl vs metformin IR+ placebo= -47mg/dl with 2hr PPG= ONGLYZA 5 mg + metformin IR= -138mg/dl vs metformin IR+ Placebo= -97mg/dl

P<0.05 vs metformin IR + placebo.

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

MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO
FPG
-13 mg/dL

(95% Cl: -19 mg/dL, -6 mg/dL)

2-Hour PPG
-41 mg/dL

(95% Cl: -57 mg/dL, -25 mg/dL)


 

STUDY DESIGN1,2

Initial Combination Therapy With ONGLYZA

Phase 3, multicenter, international, randomized, double-blind, active-controlled study

Patient profile: treatment- naïve A1C ≥8.0% and ≤12.0% (n=1306, Randomization: ONGLYZA 5 mg + metformin IR (n=320), ONGLYZA 10 mg + metformin (n=323), ONGLYZA 10 mg  + placebo (n=335), Placebo + metformin IR (n=328)
Patient profile: treatment- naive A1C ≥8.0% and ≤12.0% (n=1306, Randomization: ONGLYZA 5 mg + metformin IR (n=320), ONGLYZA 10 mg + metformin (n=323), ONGLYZA 10 mg  + placebo (n=335), Placebo + metformin IR (n=328)

*Metformin IR dose was between 1000 and 2000 mg daily. Metformin IR was initiated at a starting dose of 500 mg daily, up-titrated to 1000 mg at Week 1, and thereafter up-titrated as tolerated to a maximum of 2000 mg daily based on FPG through Week 5.

 

Study Objective

Evaluate the efficacy and safety of ONGLYZA as initial combination therapy with metformin IR compared with metformin IR monotherapy in medication-naive patients.

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary Efficacy End Points Included

  • 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; patients had to be treatment-naive

Diagnosis: T2DM

A1C: ≥8.0% and ≤12.0%

Fasting C-peptide: ≥1.0 ng/mL

Body Mass Index: ≤40 kg/m2

 

Study Dosing

  • ONGLYZA 5 mg + metformin IR*
  • Placebo + metformin IR*

*Metformin IR dose was between 1000 and 2000 mg daily. Metformin IR was initiated at a starting dose of 500 mg daily, up-titrated to 1000 mg at Week 1, and thereafter up-titrated as tolerated to a maximum of 2000 mg daily based on FPG through Week 5.

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary Efficacy End Points Included

  • 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