Saxagliptin / Metformin (2) – Komboglyze®

Diabetes mellitus type 2, combination with sulphonylurea

Characteristics

Start date 01.04.2013
Resolution 01.10.2013
INN Saxagliptin/Metformin
Brand name Komboglyze®
Pharm. company Dossier: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
New distributor: AstraZeneca GmbH
G-BA Procedure ID D-063
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, E11.41Type 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

Therapeutic indication of the resolution

Komboglyze in combination with sulfonylurea (as triple combination) is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximally tolerated dose of metformin and sulfonylurea alone.

 
Subpopulation Indication Comparator
Adult patients with type 2 diabetes mellitus when combination therapy consisting of the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose. Human insulin + metformin (if necessary, therapy with human insulin only)

Studies and Results

No. of studies
(best subpopulation) 		1 (D1680L00006)
Study design
(best subpopulation) 		H2H vs. non-ACT + ITC (Bucher)
Meta analysis
(best subpopulation) 		no

  • Clinical trials
    • For the extension of the indicated use ‘…in combination with a sulphonylurea (i.e. as triple combination therapy) as an adjunct to diet and exercise to improve blood glucose control in adult patients aged 18 years and over with type 2 diabetes mellitus, when the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose.” The placebo-controlled trial D1680L00006 formed the basis for the authorisation procedure.
    • D1680L00006 also formed the basis for the extension of the marketing authorisation for the single agent saxagliptin as a triple combination therapy with metformin and a sulphonylurea.

Triple combination of saxagliptin and metformin with a sulphonylurea, if the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose

  • For patients being treated with a triple combination therapy of saxagliptin/metformin plus a sulphonylurea (i.e. as triple combination therapy) in addition to diet and exercise, where the maximum tolerated dose of both metformin and the sulphonylurea does not adequately control blood glucose, the additional benefit is not proven.
  • Morbidity – change in HbA1c level
    • Compared with placebo, add-on therapy with saxagliptin achieved a reduction in HbA1c levels of 0.66%.
    • The proportion of patients who achieved adequate blood glucose control was 30.7% in the saxagliptin group and 9.4% in the placebo group.
  • Overall assessment
    • An overall review of the data shows no additional benefit of triple combination therapy with saxagliptin/metformin and a sulphonylurea compared with the appropriate comparator therapy of human insulin in combination with metformin.

Courtesy translation only, please refer to the German original.

Associated procedures



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