Saxagliptin / Metformin (4) – Komboglyze®

Diabetes mellitus type 2, combination therapy other than insulin and sulphonylurea

Characteristics

Start date 01.08.2017 – Marketing authorisation: 26.06.2017
Resolution 01.02.2018
INN Saxagliptin/Metformin
Brand name Komboglyze®
Pharm. company AstraZeneca GmbH
G-BA Procedure ID D-306
ATC code A10BD10 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 2 U O
Therapeutic area Metabolic diseases Diabetes mellitus (DM type 1-2)
Reason for procedure New therapeutic indication
Specialty ACT change

Therapeutic indication of the resolution

Komboglyze is indicated as an adjunct to diet and exercise to improve blood glucose control in adult patients with type 2 diabetes mellitus:

- In combination with other medicines for the treatment of diabetes (other than insulin or sulphonylureas), in patients who are not adequately controlled with metformin and these medicines.
Subpopulation Indication Comparator
Adult patients with type 2 diabetes mellitus, in patients who are not adequately controlled by treatment with at least two blood sugar-lowering medicines (other than insulin and sulphonylurea). Human insulin + metformin or human insulin + empagliflozin or human insulin + liraglutide or human insulin if metformin and empagliflozin and liraglutide are incompatible or contraindicated according to the SmPC or are not sufficiently effective due to advanced type 2 diabetes mellitus.

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 24.10.2017 – Anpassung an Versorgungsalltag

  • Clinical trials
    • The G-BA commissioned the IQWiG to assess the dossier.

Patients whose blood glucose levels are not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin and sulphonylureas), in addition to diet and exercise

  • An additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for the assessment of the additional benefit of saxagliptin/metformin in combination with other medicinal products for the treatment of diabetes (excluding insulin and sulphonylureas) compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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