Glyxambi(empagliflozin and linagliptin)
Metabolic· 2189 cited findings· 3 source documents
Company: Boehringer Ingelheim
What the regulatory reviews say
Glyxambi (empagliflozin and linagliptin) was approved on March 30, 2020, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The empagliflozin component also has an indication to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. The FDA approval date for Tradjenta (linagliptin) was May 2, 2011.
In a trial with 3492 patients enrolled, the estimated hazard ratio for MACE (Major Adverse Cardiovascular Events) for linagliptin versus placebo was 1.02 (95% CI: 0.89, 1.17). The linagliptin arm experienced 434 MACE events, with a rate of 5.8 per 100 patient years, while the placebo arm had 420 MACE events, with a rate of 5.6 per 100 patient years. The P-value for cardiovascular risk was 0.0002, and for cardiovascular benefit was 0.6301. The HbA1c change from baseline was -1.1%.
Notable safety findings included volume depletion at 0.9% and malignancy at 0.9%. There were 2 fatal pancreatitis cases reported for linagliptin.
Key figures — cited to the source page
| MACE Hazard Ratio (95% CI) | 1.02 (0.89, 1.17) | Glyxambi FDA Review, p.51 |
| Linagliptin arm MACE rate | 5.8 | Glyxambi FDA Review, p.55 |
| Placebo arm MACE rate | 5.6 | Glyxambi FDA Review, p.55 |
| HbA1c change from baseline | -1.1 | Glyxambi FDA Review, p.33 |
| Volume depletion | 0.9 | Glyxambi EMA EPAR public assessment r, p.73 |
| Malignancy | 0.9 | Glyxambi EMA EPAR public assessment r, p.73 |
| Fatal pancreatitis cases (linagliptin) | 2 | Glyxambi FDA Review, p.13 |
| Approval Date | 03/30/20 | Glyxambi FDA Review, p.1 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.