OBJECTIVES: To assess the clinical outcomes of dapagliflozin for type 2 diabetes mellitus METHODS: Randomized controlled trials of  ≥12 weeks of duration on dapagliflozin compared to placebo or another antidiabetic agents in patients with type 2 diabetes mellitus were searched using databases from inception to August 2013: The Cochrane Library, Ovid MEDLINE, EMBASE, Web of Science and databases of ongoing trials. We also hand-searched relevant reference lists of reviews on the topic of dapagliflozin published until August 2013 and contacted known experts, US and UK drug regulatory authorities websites/personnel, and manufacturers for additional trials.  RESULTS: Out of 1152 reports, 28 studies were included. Twenty-one studies compared dapagliflozin (n, 5113) to placebo (n, 2870); among these, three studies also compared dapagliflozin (n, 517) to metformin (n, 449) while one study compared dapagliflozin (n, 400) to glipizide (n, 401). Compared to placebo, dapagliflozin significantly improved HbA1C (Mean difference, MD: -0.51 %, 95% CI: -0.55, -0.47, 21 trials, 8203 participants, P<0.00001; I: 56%), fasting plasma glucose (MD: -5.72 mg/dl, 95% CI: -6.65, -4.78, 16 trials, 4942 participants, P<0.00001; I: 96%), body weight (MD: -1.81 kg, 95% CI: -2.18, -1.43, 18 trials, 6637 participants, P<0.00001; I: 72%). Similarly, compared to metformin, dapagliflozin significantly improved fasting plasma glucose and body weight. Importantly, dapagliflozin significantly increased the risk of urinary tract infections (Odds ratio, OR: 1.34, 95% CI: 1.03, 1.74, 16 trials, 6241 participants, P=0.03; I: 0%), genital infections (OR: 3.51, 95% CI: 2.37, 5.18, 16 trials, 5312 participants, P<0.00001; I: 0%) compared to placebo. Dapagliflozin, compared to metformin also, increased the risk of genital infection (OR: 4.54, 95% CI: 2.27, 9.1, 3 trials, 1148 participants, P<0.00001; I: 0%). CONCLUSIONS: Dapagliflozin significantly improved in glycaemic control but the risk of urinary tract infection and genital infection raises the concerns over its use compared to existing treatment.