Insulin degludec / Liraglutid (2) – Xultophy®
Diabetes mellitus type 2, combination with oral antidiabetics
Characteristics
| Start date | 15.08.2015 – Marketing authorisation: 25.06.2015 |
|---|---|
| Resolution | 04.02.2016 |
| INN | Insulin degludec/Liraglutid |
| Brand name | Xultophy® |
| Pharm. company | Novo Nordisk Pharma GmbH |
| G-BA Procedure ID | D-179 |
| ATC code | A10AE56 Insulins and analogues for injection, long-acting (A10AE) |
| 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, I127366Insulin resistance syndrome, type B, 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 | 40 U P |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Xultophy is used for the treatment of type 2 diabetes mellitus in adults to improve blood glucose control in combination with oral blood glucose-lowering medicines when these medicines in combination with a GLP-1 receptor agonist do not adequately regulate blood glucose levels. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with type 2 diabetes mellitus when oral antidiabetic drugs in combination with a GLP-1 receptor agonist are not sufficient for glycaemic control | Metformin + human insulin |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
- Clinical trials
- The pharmaceutical manufacturer’s research, conducted for the purpose of an indirect comparison, identified the DUAL III trial. In this randomised controlled trial, insulin degludec/liraglutide was compared with the continuation of existing treatment with a GLP-1 receptor agonist.
Insulin degludec/liraglutide in combination with oral hypoglycaemic medicinal products for the treatment of type 2 diabetes mellitus in adults, when these, in combination with a GLP-1 receptor agonist, are insufficient to control blood glucose levels
- For the combination of insulin degludec/liraglutide with oral antidiabetic agents in patients for whom oral antidiabetic agents in combination with a GLP-1 receptor agonist are insufficient for blood glucose control, there is no evidence of additional benefit compared with the appropriate comparator therapy (metformin plus human insulin or human insulin alone, if metformin is not suitable according to the SmPC) has not been proven.
- The pharmaceutical manufacturer did not identify any relevant study providing a direct comparison between insulin degludec/liraglutide and the appropriate comparator therapy determined by the G-BA.
- However, the pharmaceutical manufacturer was unable to find a study on the appropriate comparator therapy.
- For the sub-indication ‘Metformin not suitable according to the SmPC’, the pharmaceutical manufacturer also failed to submit any relevant studies suitable for an indirect comparison.
- Overall assessment
- An additional benefit of insulin degludec/liraglutide over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Insulin degludec / Liraglutid (2) | Xultophy® | Novo Nordisk Pharma GmbH | Diabetes mellitus type 2, combination with oral antidiabetics | 78,500–170,000 | 100% additional benefit not proven | |
| Insulin degludec / Liraglutid (1) | Xultophy® | Novo Nordisk Pharma GmbH | Diabetes mellitus type 2 | 752,000–903,000 | 100% additional benefit not proven |
<< List of all resolutions