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New Approach Targets Type 2’s Poorly Controlled With Metformin

Add-on of saxagliptin plus dapagliflozin shows greater improvements in glycemic control versus the use of single drug with metformin….

Because of the progressive nature of the disease, patients with type 2 diabetes regularly require various antidiabetic agents to achieve and maintain glycemic control. This study assessed the efficacy and safety of a dual add-on of saxagliptin plus dapagliflozin to metformin compared with saxagliptin or dapagliflozin alone in patients with poorly controlled type 2 diabetes. Saxagliptin and dapagliflozin have a low risk of hypoglycemia and positive effect on weight.

A multicenter, randomized, double-blind study was conducted over 24 weeks. Patients who are over 18 years of age with type 2 diabetes and inadequate HbA1c between 8-12% were eligible for screening. Also, patients had to be on a stable therapy of 1,500mg/day of metformin for more than 8 weeks and with a BMI <45kg/m2. Patients were assigned either saxagliptin 5mg/day plus dapagliflozin 10mg/day; saxagliptin 5mg/day and placebo; or dapagliflozin 10mg/day and placebo with metformin extended release >1500mg/day. The primary outcome was the change from baseline in HbA1c after 24 weeks. Secondary end points were changes from baseline in 2-h postprandial glucose, body weight, and therapeutic glycemic response (<7%) after 24 weeks.

After 24 weeks, Hb1Ac was -1.5% with saxagliptin+dapagliflozin+metformin versus -0.9% with saxagliptin+metformin (P<0.0001) versus -1.2% with dapagliflozin+metformin (P<0.02). Patients achieving HbA1c <7% was 41% with saxagliptin+dapagliflozin+metformin, 18% with saxagliptin+metformin, and 22% with dapagliflozin+metformin. There was no significant reduction in body weight and BMI among three groups. Urinary and genital infections occurred in less than 1% of patients receiving saxagliptin+dapagliflozin+metformin and there were no major incidents of hypoglycemia.

the researchers concluded that a combination of saxagliptin plus dapagliflozin with metformin in patients poorly controlled with metformin alone has a greater improvement in glycemic control compared to saxagliptin or dapagliflozin alone with metformin.

Practice Pearls:

  • A triple therapy of saxagliptin plus dapagliflozin with metformin is well tolerated and has greater improvements in glycemic control.
  • Hypoglycemia was infrequent and no episodes of major hypoglycemia were seen in the triple therapy.
  • Saxagliptin and dapagliflozin are also well-tolerated and improved glycemic control when used as a mono-therapy.

“Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: A randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin”. American Diabetes Association. September 22, 2014. http://care.diabetesjournals.org/content/early/2014/10/22/dc14-1142.full.pdf+html