Dapagliflozin as an add-on to metformin plus sulfonylurea improved glycemic control and reduced body weight in patients with type 2 diabetes, according to recent study findings published in Diabetes Care.
Stephan Matthaei, MD, of the Diabetes-Zentrum Quakenbrück in Germany, and colleagues evaluated participants (mean age, 61 years) with an HbA1c of 7% to 10.5% receiving sulfonylurea and metformin who were assigned to receive dapagliflozin (Farxiga, Bristol-Myers Squibb and AstraZeneca) 10 mg/day (n=109) or placebo (n=109) to determine the effect on inadequate glycemic control.
Compared with the placebo group, the dapagliflozin group had significantly reduced HbA1c levels from baseline to 24 weeks (P<.0001). At week 24, more patients on dapagliflozin achieved a therapeutic glycemic response compared with those receiving placebo (P<.0001). Fasting plasma glucose and body weight also decreased more throughout the study period among the dapagliflozin group compared with placebo (both P<.0001).
From baseline to week 8, patients assigned dapagliflozin had a significantly greater reduction in seated systolic blood pressure compared with those assigned placebo (P=.025).
Ten placebo patients required rescue for lack of glycemic control at week 24 compared with zero dapagliflozin patients.
Placebo-subtracted increases were seen in total (P=.0091), LDL (P=.003) and HDL cholesterol (P=.0172) among patients in the placebo group; no differences were observed in LDL-HDL cholesterol ratio (P=.2008) or triglyceride levels (P=.1755). No change was seen in serum levels of C-peptide in either group.
The placebo (51.4%) and dapagliflozin (48.6%) groups had similar rates of adverse events. Compared with the placebo group, the dapagliflozin group experienced more events of hypoglycemia (P=.024) and genital infections (P=.029).
“The results presented here indicate that triple combination therapy that includes dapagliflozin 10 mg/day with metformin and sulfonylurea is a suitable treatment option for patients with inadequate glycemic control on metformin and a sulfonylurea, with the added benefits of weight loss and BP reduction,” the researchers wrote. “Consistent with other [sodium-glucose cotransporter 2] inhibitors, dapagliflozin was associated with an increase in frequency of genital infections and increase in total, LDL and HDL cholesterol that may necessitate additional lipid management.”
Disclosure: The study was sponsored by Bristol-Myers Squibb and AstraZeneca. Matthaei reports various financial ties with Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, Lilly, Merck, Novartis, Novo Nordisk, Roche and Sanofi.