Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial
International Journal of Clinical Practice, 04/23/2012
Henry RR et al. - In treatment-naïve patients with type 2 diabetes (T2D), dapagliflozin plus metformin was generally well tolerated and effective in reducing HbA1c, fasting plasma glucose (FPG) and weight. Dapagliflozin-induced glucosuria led to an increase in events suggestive of urinary tract and genital infections.
Eligible patients had baseline HbA1c 7.5-12%.
Each trial had three arms: dapagliflozin plus metformin, dapagliflozin monotherapy and metformin monotherapy.
Dapagliflozin in combination and as monotherapy was dosed at 5mg (Study 1) and 10 mg (Study 2).
Metformin in combination and as monotherapy was titrated to 2000 mg.
The primary endpoint was HbA1c change from baseline; secondary endpoints included change in fasting plasma glucose (FPG) and weight.
In both trials, combination therapy led to significantly greater reductions in HbA1c compared with either monotherapy: -2.05 for dapagliflozin + metformin, -1.19 for dapagliflozin, and -1.35 for metformin (p<0.0001) (Study 1); -1.98 for dapagliflozin + metformin, -1.45 for dapagliflozin and -1.44 for metformin (p<0.0001) (Study 2).
Combination therapy was statistically superior to monotherapy in reduction of FPG (p<0.0001 for both studies); combination therapy was more effective than metformin for weight reduction (p<0.0001).
Dapagliflozin 10 mg was non-inferior to metformin in reducing HbA1c (Study 2).
Events suggestive of genital infection were reported in 6.7%, 6.9% and 2.0% (Study 1) and 8.5%, 12.8% and 2.4% (Study 2) of patients in combination, dapagliflozin and metformin groups; events suggestive of urinary tract infection were reported in 7.7%, 7.9% and 7.5% (Study 1) and 7.6%, 11.0% and 4.3% (Study 2) of patients in the respective groups.
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