Dapagliflozin (1) – Forxiga®
Diabetes mellitus type 2
Characteristics
| Start date | 15.12.2012 – Marketing authorisation: 11.11.2012 |
|---|---|
| Resolution | 06.06.2013 repealed |
| INN | Dapagliflozin |
| Brand name | Forxiga® |
| Pharm. company |
Dossier: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
New distributor: AstraZeneca GmbH |
| G-BA Procedure ID | D-045 |
| ATC code | A10BK01 SGLT2 inhibitors (A10BK) |
| DDD | 10 mg O |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure |
Initial assessment
Repealed by: Dapagliflozin (2) (21.06.2018) |
| Therapeutic indication of the resolution |
|---|
|
Forxiga is indicated in adults 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) | Treatment of adult patients aged 18 years and over with type 2 diabetes mellitus to improve glycaemic control: monotherapy in patients in whom diet and exercise do not adequately control blood glucose and in whom the use of metformin is considered inappropriate due to intolerance. | Sulphonylurea |
| b) | Treatment of adult patients aged 18 years and over with type 2 diabetes mellitus to improve glycaemic control: add-on combination therapy with metformin when metformin together with diet and exercise does not adequately control blood glucose. | Sulphonylurea + metformin |
| c) | Treatment of adult patients aged 18 years and over with type 2 diabetes mellitus to improve blood glucose control: add-on combination therapy with other blood glucose-lowering medicines (except metformin and insulin) if these do not adequately control blood glucose together with diet and exercise: | Metformin + sulphonylurea |
| d) | Treatment of adult patients aged 18 years and over with type 2 diabetes mellitus to improve glycaemic control: add-on combination therapy with insulin when insulin therapy together with diet and exercise does not adequately control blood glucose. | Metformin + human insulin |
Studies and Results
|
No. of studies
(best subpopulation) |
3 (D1690C00006, D1690C00018,D1690C00019) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (MTC) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Number of medications |
a) Monotherapy in patients in whom diet and exercise do not adequately control blood glucose levels and in whom the use of metformin is considered unsuitable due to intolerance
- For patients treated with dapagliflozin monotherapy, in whom diet and exercise do not adequately control blood glucose levels and in whom the use of metformin is considered unsuitable due to intolerance, the additional benefit is not proven.
- In its summary assessment of the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that there is no additional benefit of dapagliflozin over the appropriate comparator therapy – sulphonylureas (glibenclamide, glimepiride)—has been established.
b) Add-on combination therapy with metformin, where metformin, together with diet and exercise, does not adequately control blood glucose
- Having assessed the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that no additional benefit of dapagliflozin over the appropriate comparator therapy – sulphonylureas (glibenclamide, glimepiride) combined with metformin.
- morbidity
- The D1690C00004 study investigated adult patients with type 2 diabetes mellitus in whom adequate blood glucose control had not been achieved despite metformin monotherapy at a daily dose of ≥ 1500 mg.
- The results of study D1690C00004 may be biased due to the shortcomings mentioned above and cannot be interpreted; consequently, the G-BA cannot make a valid assessment regarding the individual endpoints of the study.
c) Add-on combination therapy with other blood glucose-lowering medicinal products (other than metformin and insulin), where these do not adequately control blood glucose levels in conjunction with diet and exercise
- For patients being treated with add-on combination therapy comprising dapagliflozin and other blood glucose-lowering medicinal products (other than metformin and insulin), where these do not adequately control blood glucose levels in conjunction with diet and exercise, the additional benefit is not proven.
- In its assessment of the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that dapagliflozin offers no additional benefit compared with the appropriate comparator therapy of sulphonylureas (glibenclamide, glimepiride) + metformin.
d) Add-on combination therapy with insulin, where insulin therapy, in combination with diet and exercise, does not adequately control blood glucose
- For patients treated with add-on combination therapy of dapagliflozin and insulin, in whom insulin therapy, together with diet and exercise, does not adequately control blood glucose, the additional benefit is not proven.
- In its summary assessment of the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that no additional benefit of dapagliflozin has been established compared with the appropriate comparator therapy of metformin + human insulin or human insulin alone.
Courtesy translation only, please refer to the German original.
Associated procedures
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