Dapagliflozin Versus Glipizide as Add-on Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin: A randomized, 52-week, double-blind, active-controlled noninferiority trial Full Text
Diabetes Care, 08/08/2011
Nauck MA et al. – Despite similar 52–week glycemic efficacy, dapagliflozin reduced weight and produced less hypoglycemia than glipizide in type 2 diabetes inadequately controlled with metformin. Long–term studies are required to further evaluate genital and urinary tract infections with sodium–glucose cotransporter 2 (SGLT2) inhibitors.Methods
- This 52–week, double–blind, multicenter, active–controlled, noninferiority trial randomized patients with type 2 diabetes (baseline mean HbA1c, 7.7%), who were receiving metformin monotherapy, to add–on dapagliflozin (n = 406) or glipizide (n = 408) up–titrated over 18 weeks, based on glycemic response and tolerability, to ≤10 or ≤20 mg/day, respectively.
- The primary end point, adjusted mean HbA1c reduction with dapagliflozin (–0.52%) compared with glipizide (–0.52%), was statistically noninferior at 52 weeks.
- Key secondary end points: dapagliflozin produced significant adjusted mean weight loss (–3.2 kg) versus weight gain (1.2 kg; P < 0.0001) with glipizide, significantly increased the proportion of patients achieving ≥5% body weight reduction (33.3%) versus glipizide (2.5%; P < 0.0001), and significantly decreased the proportion experiencing hypoglycemia (3.5%) versus glipizide (40.8%; P < 0.0001).
- Events suggestive of genital infections and lower urinary tract infections were reported more frequently with dapagliflozin compared with glipizide but responded to standard treatment and rarely led to study discontinuation.