Ertugliflozin / Sitagliptin (1) – Steglujan®
Diabetes mellitus type 2
Characteristics
| Start date | 15.05.2018 – Marketing authorisation: 23.03.2018 |
|---|---|
| Resolution | 01.11.2018 |
| INN | Ertugliflozin/Sitagliptin |
| Brand name | Steglujan® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-361 |
| ATC code | A10BD24 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 | 10 mg O |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: – when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control. – in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with type 2 diabetes mellitus who are not adequately controlled by treatment with at least two blood sugar-lowering medicines (other than insulin, in this case metformin and/or sulphonylurea and ertugliflozin or sitagliptin). | Human insulin + metformin or human insulin + empagliflozin or human insulin + liraglutide or human insulin if the specific combination partners are incompatible or contraindicated according to the summary of product characteristics or are not sufficiently effective due to advanced type 2 diabetes mellitus. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (VERTIS SITA 2) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 12.06.2018 – nach Dossiereinreichung |
- Clinical trials
- For the benefit assessment pursuant to Section 35a of the German Social Code, Book V (SGB V), the pharmaceutical manufacturer draws on the randomised, double-blind, placebo-controlled, multicentre registration trial VERTIS SITA 2 for an indirect comparison.
Adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin; in this case, metformin and/or sulphonylurea and ertugliflozin or sitagliptin)
- For adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin; in this case, metformin and/or a sulphonylurea and ertugliflozin or sitagliptin) are not adequately controlled, an additional benefit is not proven.
- An additional benefit is not proven.
- The pharmaceutical manufacturer has not submitted any randomised controlled trials (RCTs) that allow for a direct comparison with the appropriate comparator therapy.
- The VERTIS SITA 2 study is not used for the benefit assessment, as it does not contain suitable data allowing a direct comparison of ertugliflozin/sitagliptin with the appropriate comparator therapy.
- For an indirect comparison, no relevant studies using the bridging comparator were identified that would have been suitable for assessing the additional benefit compared with the appropriate comparator therapy.
- Overall, there are therefore no data available for assessing the additional benefit of ertugliflozin/sitagliptin compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Ertugliflozin / Sitagliptin (1) | Steglujan® | MSD Sharp & Dohme GmbH | Diabetes mellitus type 2 | 326,100–341,100 | 100% additional benefit not proven |
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