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The tablets are licensed for use in patients with type II diabetes inadequately controlled by metformin alone and in those currently receiving the combination as separate tablets, or with insulin when insulin plus metformin is inadequate.
Komboglyze provides fixed doses of two hypoglycaemic agents with complementary mechanisms of action: saxagliptin, a dipeptidyl peptidase 4 inhibitor and metformin, a member of the biguanide class.
Greater HBA1c reduction than placebo
In a 12-week study, 160 patients whose blood glucose levels were not adequately controlled by metformin alone were randomised to receive placebo or saxagliptin 2.5mg twice daily in addition to metformin.
After 12 weeks, patients in the saxagliptin plus metformin group had a greater reduction in HbA1c than those in the placebo plus metformin group (0.6% vs 0.2%, p=NS).
Efficacious in combination with insulin
In another study, 455 patients with diabetes inadequately controlled by insulin or insulin plus metformin were randomised to receive saxagliptin 5mg or placebo as add-on therapy. After 24 weeks, significant improvements in HbA1c and postprandial glucose were observed in the saxagliptin add-on group compared with the placebo group.
View Komboglyze drug record
Further information: BMS/AstraZeneca
