Saxagliptin / Metformin (2) – Komboglyze®

• Clinical trials
  • For the extension of the indicated use ‘…in combination with a sulphonylurea (i.e. as triple combination therapy) as an adjunct to diet and exercise to improve blood glucose control in adult patients aged 18 years and over with type 2 diabetes mellitus, when the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose.” The placebo-controlled trial D1680L00006 formed the basis for the authorisation procedure.
  • D1680L00006 also formed the basis for the extension of the marketing authorisation for the single agent saxagliptin as a triple combination therapy with metformin and a sulphonylurea.

Triple combination of saxagliptin and metformin with a sulphonylurea, if the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose

• For patients being treated with a triple combination therapy of saxagliptin/metformin plus a sulphonylurea (i.e. as triple combination therapy) in addition to diet and exercise, where the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose, the additional benefit is not proven.
• Morbidity – change in HbA1c level
  • Compared with placebo, add-on therapy with saxagliptin achieved a reduction in HbA1c levels of 0.66%.
  • The proportion of patients who achieved adequate blood glucose control was 30.7% in the saxagliptin group and 9.4% in the placebo group.
• Overall assessment
  • An overall review of the data shows no additional benefit of triple combination therapy with saxagliptin/metformin and a sulphonylurea compared with the appropriate comparator therapy of human insulin in combination with metformin.

Courtesy translation only, please refer to the German original.