ADULTS WITH TYPE 2 DIABETES, ALONG WITH DIET AND EXERCISE

RETHINK THE MATH WHEN IT COMES TO A1c

GLYXAMBI can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes, and can be used in adults with type 2 diabetes who have known cardiovascular (CV) disease when empagliflozin (JARDIANCE), one of the medicines in GLYXAMBI, is needed to reduce the risk of cardiovascular death.

Efficacy

FOR ADULTS WITH TYPE 2 DIABETES NOT AT GOAL ON METFORMIN*

Superior A1c reductions vs each individual component

MEAN A1c REDUCTIONS OVER 24 WEEKS (COMPLETERS)

Individual component mean A1c achieved from the completer analysis: 7.3% for linagliptin 5 mg, 7.3% for empagliflozin 10 mg, 7.3% for empagliflozin 25 mg.

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 ≥1500 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 vs linagliptin at 24 weeks were key secondary endpoints.

  • * GLYXAMBI does not contain metformin.
  • † 1889 mg/day mean dose metformin.1
  • ‡ ADA recommends an A1c target <7%. Individual goal of patient should be determined by their physician.
  • Type ADA=American Diabetes Association; DPP-4i=dipeptidyl peptidase-4 inhibitor; FPG=fasting plasma glucose; SGLT2i=sodium glucose co-transporter-2 inhibitor.

Mean A1c change in patients with baseline ≥8.5% (subgroup analysis)*

A1c CHANGE FROM A MEAN BASELINE OF 9.1% AT WEEK 241

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 ≥1500 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 vs linagliptin at 24 weeks were key secondary endpoints.

  • * Exploratory endpoint; ≥8.5% baseline stratified at randomization.1
  • DPP-4i=dipeptidyl peptidase-4 inhibitor; FPG=fasting plasma glucose; SGLT2i=sodium glucose co-transporter-2 inhibitor.

FOR ADULTS WITH TYPE 2 DIABETES NOT AT GOAL ON METFORMIN*

~2x more patients achieved A1c goal of <7% with GLYXAMBI vs each individual component

PERCENT OF PATIENTS WHO ACHIEVED GOAL AT WEEK 24

Glyxambi A1c case study

  • *GLYXAMBI does not contain metformin.
  • DPP-4i=dipeptidyl peptidase-4 inhibitor; SGLT2i=sodium glucose co-transporter-2 inhibitor.

Experience some weight loss

While not a weight-loss product, people taking GLYXAMBI
lost 3% of their body weight on average.

In a 6-month study of adults taking metformin, people adding GLYXAMBI 10 mg/5 mg or 25 mg/5 mg saw average reductions of 3.1% and 3.4%, while adults adding empagliflozin 10 mg or 25 mg lost 3% and 3.5% and adults adding linagliptin 5 mg lost 0.7%1.

Reference

  • DeFronzo RA, Lewin A, Patel S, et al. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015;38(3):384-393.