Dapagliflozin (7) – Forxiga®
Diabetes mellitus Type 2, ≥ 10 years
Characteristics
| Start date | 15.12.2021 – Marketing authorisation: 15.11.2021 |
|---|---|
| Resolution | 16.06.2022 |
| INN | Dapagliflozin |
| Brand name | Forxiga® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-760 |
| ATC code | A10BK01 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), 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, I99064Hypoglycemic coma in type 2 diabetes mellitus, I99192Type 2 diabetes mellitus with ketoacidosis, I99238Diabetes mellitus type 2 with hypoglycemia |
| DDD | 10 mg O |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise – as monotherapy when metformin is considered inappropriate due to intolerance – in addition to other medicinal products for the treatment of type 2 diabetes |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Insulin-naïve children and adolescents aged 10 to 17 years with diabetes mellitus (DM) type 2 who have not achieved sufficient blood glucose control with their previous drug therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise. | Human insulin + Metformin |
| b) | Insulin-experienced children and adolescents aged 10 to 17 years with diabetes mellitus (DM) type 2 who, with their previous insulin regime in addition to diet and exercise have not achieved sufficient blood glucose control | Escalation of insulin therapy (conventional therapy (CT) if necessary + metformin or intensified insulin therapy (ICT)). |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (D1690C00017) |
|---|---|
|
Study design
(best subpopulation) |
Evidence transfer |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
- Clinical trials
- In the double-blind, multicentre, randomised Phase III trial D1690C00017, dapagliflozin was compared with placebo in patients with type 2 diabetes mellitus aged between 10 and 24 years, in each case in addition to background therapy.
a) Insulin-naïve 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
- An additional benefit is not proven.
- Study D1690C00017 is not suitable for assessing the additional benefit of dapagliflozin, as the appropriate comparator therapy was not implemented.
- Furthermore, the pharmaceutical manufacturer treats all included patients as a single population and does not subdivide them into the two patient groups defined by the G-BA.
- Overall, the pharmaceutical manufacturer has not submitted any suitable studies for this patient population from which an additional benefit of dapagliflozin over the appropriate comparator therapy can be inferred.
- Overall assessment
- On the basis of the study submitted, no conclusions can be drawn regarding the additional benefit of dapagliflozin compared with the appropriate comparator therapy.
b) Children and adolescents aged 10 to 17 with type 2 diabetes mellitus who have previously used insulin but have not achieved adequate blood glucose control with their current insulin regimen, in addition to diet and exercise
- The additional benefit is not proven.
- Study D1690C00017 is not suitable for assessing the additional benefit of dapagliflozin, as the appropriate comparator therapy was not implemented.
- Furthermore, the pharmaceutical manufacturer treats all included patients as a single population and does not subdivide them into the two patient groups defined by the G-BA.
- Overall, the pharmaceutical manufacturer has not submitted any suitable studies for this patient population from which an additional benefit of dapagliflozin over the appropriate comparator therapy can be inferred.
- Overall assessment
- On the basis of the study submitted, no conclusions can be drawn regarding the additional benefit of dapagliflozin compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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