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For Healthcare Professionals

GLYXAMBI®

Efficacy

FOR ADULTS WITH TYPE 2 DIABETES UNCONTROLLED ON METFORMIN.1

Superior A1C reductions vs each individual component

MEAN A1C REDUCTIONS OVER 24 WEEKS (COMPLETERS)1

Mean A1C achieved by GLYXAMBI® 25/5 mg: 6.7%
Uncontrolled on metformin ≥1,500 mg alone
Mean baseline for GLYXAMBI® 25/5 mg: 7.9%

 

A1C_reduction_renew

 

Individual component mean A1C achieved from the completer analysis: 7.3% for linagliptin 5 mg, 7.3% for empagliflozin 10 mg, 7.4% for empagliflozin 25 mg.1

In the modified intent-to-treat analysis of the primary endpoint, the adjusted mean A1C change from baseline for GLYXAMBI® 25/5 mg, -1.2% (n=134); linagliptin 5 mg, -0.7% (n=128); empagliflozin 10 mg, -0.7% (n=137); empagliflozin 25 mg, -0.6% (n=140). GLYXAMBI® vs individual components, p<0.001.1

Study design:

A Phase 3, randomized, double-blind efficacy and safety study of fixed-dose combination GLYXAMBI® administered orally vs the individual components of empagliflozin and linagliptin over 52 weeks in adult patients (N=686) with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1,500 mg alone. The primary endpoint was A1C change from baseline at 24 weeks. Achievement of A1C target <7.0%, FPG change from baseline, and weight change from baseline at 24 weeks were key secondary endpoints.1

 

Mean A1C change in patients with baseline ≥8.5% (subgroup analysis)†

A1C CHANGE FROM A MEAN BASELINE OF 9.1% AT WEEK 24.1

A1C_mean_change_renew

 

DPP-4i (linagliptin 5 mg) (n=33, mean baseline: 9.3%) = -1.0%

Study design:

A Phase 3, randomized, double-blind efficacy and safety study of fixed-dose combination GLYXAMBI® administered orally vs the individual components of empagliflozin and linagliptin over 52 weeks in adult patients (N=686) with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1,500 mg alone. The primary endpoint was A1C change from baseline at 24 weeks. Achievement of A1C target <7.0%, FPG change from baseline, and weight change from baseline at 24 weeks were key secondary endpoints.1

 

FOR ADULTS WITH TYPE 2 DIABETES UNCONTROLLED ON METFORMIN.

In addition to lowering A1C, GLYXAMBI® reduced weight1‡

MEAN WEIGHT LOSS AT WEEK 24.

 

Weight-loss

Study Design:

A Phase 3, randomized, double-blind efficacy and safety study of fixed-dose combination GLYXAMBI® administered orally vs the individual components of empagliflozin and linagliptin over 52 weeks in adult patients (N=686) with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1,500 mg alone. The primary endpoint was A1C change from baseline at 24 weeks. Achievement of A1C target <7.0%, FPG change from baseline, and weight change from baseline at 24 weeks were key secondary endpoints.1

Footnotes:

  • DPP-4i, dipeptidyl peptidase-4 inhibitor; SGLT2i, sodium glucose co-transporter-2 inhibitor.
  • * ADA recommends an A1C target of <7%. Individual goal of patient should be determined by their physician. Change from baseline vs individual components, p<0.0001.1
  • † Exploratory endpoint; ≥8.5% baseline stratified at randomization.1
  • ‡ GLYXAMBI® is not indicated for weight loss. Weight change from baseline vs linagliptin was a secondary endpoint.

References:

  1. DeFronzo RA, Lewin A, Patel S, et al. Diabetes Care. 2015;38(3):384-393.

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