Empagliflozin (6) – Jardiance®

Diabetes Mellitus Type 2, ≥ 10 years

Characteristics

Start date 01.01.2024 – Marketing authorisation: 07.12.2023
Resolution 20.06.2024
INN Empagliflozin
Brand name Jardiance®
Pharm. company Boehringer Ingelheim Pharma GmbH
G-BA Procedure ID D-1006
ATC code A10BK03 SGLT2 inhibitors (A10BK)
ICD-10 codes (AIS) E11.01Type 2 diabetes mellitus with hyperosmolarity with coma, E11.11Type 2 diabetes mellitus with ketoacidosis with coma, E11.20, E11.21Type 2 diabetes mellitus with intercapillary glomerulosclerosis, E11.30, E11.31Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema, E11.40Type 2 diabetes mellitus with diabetic neuropathy, unspecified, E11.41Type 2 diabetes mellitus with diabetic mononeuropathy, E11.50, E11.51Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene, E11.60, E11.61Type 2 diabetes mellitus with diabetic neuropathic arthropathy, E11.72, E11.73, E11.74, E11.75, E11.80, E11.81, E11.90, E11.91, E12.01, E12.11, E12.20, E12.21, E12.30, E12.31, E12.40, E12.41, E12.50, E12.51, E12.60, E12.61, E12.72, E12.73, E12.74, E12.75, E12.80, E12.81, E12.90, E12.91 Show more >>
Alpha-ID codes (AIS) I111702Diabetes mellitus type 2b with nephropathy, I111707Diabetes mellitus type 2b with complications, I115660Type 2 diabetes mellitus with diabetic foot syndrome, I119462Type 2 diabetes mellitus in conjunction with malnutrition (malnutrition), I133534MODY (maturity onset diabetes of young people) with peripheral vascular complication, derailed, I133535MODY (maturity onset diabetes of young people) with complication, derailed, I135045MODY (maturity onset diabetes of young people) without complication, derailed, I135047MODY (maturity onset diabetes of young people) with multiple complications, derailed, I135048MODY (maturity onset diabetes of young people) with diabetic foot syndrome, derailed, I99009Type 2 diabetes mellitus with coma, I99030Type 2 diabetes mellitus with peripheral vascular complication, I99034Type 2 diabetes mellitus with multiple complications, I99037Diet-treated type 2 diabetes mellitus without complications, I99055Hypoglycemic shock in type 2 diabetes mellitus, I99192Type 2 diabetes mellitus with ketoacidosis, I99238Diabetes mellitus type 2 with hypoglycemia
Therapeutic area Metabolic diseases Diabetes mellitus (DM type 1-2)
Reason for procedure New therapeutic indication
Specialty ACT change Combination therapy

Therapeutic indication of the resolution

Jardiance is used in children and adolescents aged 10 to 17 years for the treatment of inadequately treated type 2 diabetes mellitus as an adjunct to diet and exercise

– as monotherapy if metformin is considered unsuitable due to intolerance

– in addition to other medicines for the treatment of diabetes
Subpopulation Indication Comparator
Children and adolescents aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate blood glucose control with their previous drug therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise A patient-individualised therapy taking into account the HbA1c value, previous therapies and complications with the selection of – Metformin + human insulin – Metformin + liraglutide or dulaglutide – metformin + dapagliflozin – escalation of insulin therapy: conventional therapy [CT] or intensified insulin therapy [ICT], in each case in combination with metformin and liraglutide or dulaglutide or dapagliflozin

Studies and Results

No. of studies
(best subpopulation) 		1 (DINAMO)
Study design
(best subpopulation) 		H2H vs. ACT
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Previous treatment
ACT change 30.03.2023 – Leitlinien

  • Clinical trials
    • As part of the benefit assessment, the pharmaceutical manufacturer presents the results of the double-blind, multicentre DINAMO trial, in which empagliflozin was compared with linagliptin and placebo in patients with type 2 diabetes mellitus aged 10 to 17 years inclusive, in each case in addition to diet, exercise and a stable dose of metformin, insulin or metformin plus insulin.

Children and adolescents aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate blood glucose control with their current drug therapy consisting of at least one blood glucose-lowering medicinal product in addition to diet and exercise

  • The additional benefit is not proven.
  • Overall, there are therefore no suitable data available to assess the additional benefit of empagliflozin compared with the appropriate comparator therapy in children and adolescents aged 10 to 17 years with uncontrolled type 2 diabetes mellitus. An additional benefit of empagliflozin compared with the appropriate comparator therapy is not proven.
  • morbidity
    • The primary endpoint of the study was the change in HbA1c levels from the start of the study to week 26.
    • Further endpoints were assessed in the categories of morbidity and side effects.
  • Overall review
    • Overall, for children and adolescents aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate blood glucose control with their current medication regimen—consisting of at least one blood glucose-lowering medicinal product in addition to diet and exercise— The additional benefit of empagliflozin compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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