Canagliflozin / Metformin (1) – Vokanamet®
Diabetes mellitus type 2
Characteristics
| Start date | 15.08.2014 – Marketing authorisation: 23.04.2014 |
|---|---|
| Resolution | 05.02.2015 |
| INN | Canagliflozin/Metformin |
| Brand name | Vokanamet® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-124 |
| ATC code | A10BD16 Combinations of oral blood glucose lowering drugs (A10BD) |
| 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, E13.01Other specified diabetes mellitus with hyperosmolarity with coma, E13.11Other specified diabetes mellitus with ketoacidosis with coma, E13.20, E13.21Other specified diabetes mellitus with intercapillary glomerulosclerosis, E13.30, E13.31Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema, E13.40Other specified diabetes mellitus with diabetic neuropathy, unspecified, E13.41Other specified diabetes mellitus with diabetic mononeuropathy, E13.50, E13.51Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene, E13.60, E13.61Other specified diabetes mellitus with diabetic neuropathic arthropathy, E13.72, E13.73, E13.74, E13.75, E13.80, E13.81, E13.90, E13.91, E14.01, E14.11, E14.20, E14.21, E14.30, E14.31, E14.40, E14.41, E14.50, E14.51, E14.60, E14.61, E14.72, E14.73, E14.74, E14.75, E14.80, E14.81, E14.90, E14.91 Show more >> |
| Alpha-ID codes (AIS) | I110911Diabetic foot syndrome, I110976Diabetes mellitus with eye complications, I110978Diabetes mellitus with neurological complications, I111029Diabetes mellitus with complication, I111031Diabetes mellitus with vascular complication, I111458Secondary diabetes mellitus, I111462Diabetic derailment, 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), I127364Insulin resistance syndrome, type A, I127626Wolfram syndrome, I2202Diabetes mellitus without complications, I25564Diabetes mellitus with coma, I31391Diabetes mellitus with multiple complications, I97452Diabetes mellitus with hypoglycemia, I98004Diabetes mellitus with ketoacidosis, I98511Hypoglycemic coma in diabetes mellitus, 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 | 0.2 g O |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Vokanamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise: - in patients insufficiently controlled on their maximally tolerated doses of metformin alone - in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products - in patients already being treated with the combination of canagliflozin and metformin as separate tablets. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with type 2 diabetes mellitus when metformin at the maximum tolerated dose does not adequately control blood glucose along with diet and exercise. | Sulfonylurea (glibenclamide or glimepiride) + metformin |
| b) | Adult patients with type 2 diabetes mellitus when blood glucose is not adequately controlled with metformin and other blood glucose-lowering medicines (except insulin) together with diet and exercise. | Human insulin + metformin (if necessary, therapy with human insulin only) |
| c) | Adult patients with type 2 diabetes mellitus when blood glucose is not adequately controlled with metformin and insulin, together with diet and exercise. | Human insulin + metformin (if necessary, therapy with human insulin only) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (DIA3009) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT (off-label) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- This three-arm, double-blind, multicentre, randomised clinical trial investigated the efficacy and safety of canagliflozin in combination with metformin compared with a combination of metformin and glimepiride over a period of 104 weeks.
- The DIA3006 study was a four-arm, double-blind, randomised clinical trial with a total duration of 52 weeks.
a) Combination therapy with metformin, where metformin at the maximum tolerated dose, together with diet and exercise, does not adequately control blood glucose
- For the combination of canagliflozin and metformin, where metformin monotherapy, together with diet and exercise, does not adequately control blood glucose, the additional benefit is not proven.
- Having assessed the methodological shortcomings described in the data submitted for this patient group from the DIA3009 study, as well as the failure to take into account the specified appropriate comparator therapy in the DIA3006 study, the G-BA concludes that no additional benefit has been established for canagliflozin in combination with metformin compared with the appropriate comparator therapy of a sulphonylurea (glibenclamide or glimepiride) with metformin.
- Overall assessment
- The validity of study DIA3009 is limited, amongst other things, by the inability to increase the dose of canagliflozin and by the strict glimepiride titration regimen, which is further constrained by a low target value (fasting plasma glucose: 110 mg/dL; guideline for the treatment target: 100–125 mg/dL), is so limited that no valid conclusions regarding additional benefit can be drawn.
b) Combination therapy with other blood glucose-lowering medicinal products other than insulin, where blood glucose is not adequately controlled with metformin and these medicinal products in conjunction with diet and exercise
- For the combination of canagliflozin/metformin with other blood glucose-lowering medicinal products (other than insulin), where blood glucose is not adequately controlled with metformin and these medicinal products in conjunction with diet and exercise, the additional benefit is not proven.
- No study has been submitted to assess the additional benefit of a treatment consisting of canagliflozin in combination with metformin and other blood glucose-lowering medicinal products (other than insulin), where blood glucose is not adequately controlled with metformin and these medicinal products in combination with diet and exercise, compared with the appropriate comparator therapy (human insulin + metformin or human insulin alone).
c) Combination therapy with insulin, where blood glucose is not adequately controlled with metformin and insulin, together with diet and exercise
- For combination therapy with canagliflozin and metformin plus insulin, where blood glucose is not adequately controlled with metformin and insulin in conjunction with diet and exercise, the additional benefit is not proven.
- No study was submitted to assess the additional benefit of a treatment consisting of canagliflozin in combination with metformin and insulin – where blood glucose is not adequately controlled by metformin and insulin in conjunction with diet and exercise – compared with the appropriate comparator therapy (human insulin + metformin or human insulin alone) would have been suitable.
Courtesy translation only, please refer to the German original.
Associated procedures
| Canagliflozin / Metformin (1) | Vokanamet® | Janssen-Cilag GmbH | Diabetes mellitus type 2 | 615,300 | 100% additional benefit not proven |
<< List of all resolutions