Dulaglutid (3) – Trulicity®
Diabetes mellitus type 2, ≥ 10 years
Characteristics
| Start date | 01.04.2023 – Marketing authorisation: 06.03.2023 |
|---|---|
| Resolution | 21.09.2023 |
| INN | Dulaglutid |
| Brand name | Trulicity® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-918 |
| ATC code | A10BJ05 GLP-1 analogues (A10BJ) |
| 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, 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 |
|---|
|
For the treatment of children and adolescents aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus in support of diet and exercise: - As monotherapy when metformin use is not indicated due to intolerance or contraindications. contraindications is not indicated. - in addition to other drugs for the treatment of diabetes mellitus. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents between the ages of 10 and 17 with type 2 diabetes mellitus who have not responded to therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise in addition to diet and exercise, have not achieved sufficient blood glucose control. | A patient-specific therapy taking into account the HbA1c level, previous therapies and complications with selection of o Metformin + human insulin o metformin + liraglutide o an escalation of insulin therapy (conventional therapy (CT) if necessary + metformin or intensified insulin therapy (ICT)) |
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) |
| ACT change | 11.01.2022 – Änderung der Leitlinen |
Children and adolescents aged between 10 and 17 with type 2 diabetes mellitus who do not achieve 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, on the basis of the study presented, no conclusions can be drawn regarding the additional benefit of dulaglutide compared with the appropriate comparator therapy.
- Conclusion
- On the whole, no conclusions can be drawn from the study presented regarding the additional benefit of dulaglutide compared with the appropriate comparator therapy. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Dulaglutid (3) | Trulicity® | Lilly Deutschland GmbH | Diabetes mellitus type 2, ≥ 10 years | 640–710 | 100% additional benefit not proven | |
| Dulaglutid (2) | Trulicity® | Lilly Deutschland GmbH | Diabetes mellitus type 2 | 2,108,000 | 31% Hint for minor additional benefit | |
| Dulaglutid (1) | Trulicity® | Lilly Deutschland GmbH | Diabetes mellitus type 2 |
0
1,705,500–1,905,500 |
31% Hint for minor additional benefit repealed |
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