To investigate the efficacy and safety of dapagliflozin versus linagliptin in overweight or obesity type 2 diabetic patients with poor glycemic control of oral antidiabetc drugs.

T2DM patients with body mass index (BMI) >25 kg/m², glycosylated hemoglobin A_1c (HbA_1c) 7.5%-9.0% were recruited in this randomized, open-labelled, parallel-group study from March 2017 to January 2018 in the Department of Endocrinology, Quanzhou First Hospital Affiliated Fujian Medical University. A total of 141 subjects (74 males and 67 females) with a mean age of (49.5±11.8) years who received metformin (at least 1 500 mg/d) and sulfonylureas (at least half of the maximal dose) for at least 3 months were randomly assigned to 2 groups: additional 24-week treatment of dapagliflozin 10 mg once a day (n=71) or linagliptin 5 mg once a day (n=70). HbA_1c, plasma glucose, body weight, blood pressure, lipid profiles, serum uric acid, urinary albumin/creatinine and adverse events at baseline and after 24 weeks were evaluated. Statistical analysis was performed using t-test, Mann-Whitney U test and Chi-Square test for different data.

Compared with the data of baseline, HbA_1c decreased 1.2%±0.4% in dapagliflozin group (8.6%±0.4% to 7.4%±0.5%) and 0.9%±0.4% in linagliptin group (8.5%±0.4% to 7.6%±0.6%) (t=3.61, P=0.00) respectively after 24-week treatment. The proportion of patients with HbA_1c less than 7.0% were 53.5% (38/71) and 34.2% (24/70) in dapagliflozin group and linagliptin group (χ²=5.32, P=0.02), respectively. The reduction of body weight from baseline to week 24 was significantly greater in dapagliflozin group with a decrease of 2 (1.1, 2.0) kg than that in linagliptin group with a decrease of -0.3 (-0.5,0) kg (Z=-9.50, P=0.00). After 24-week treatment, SBP decreased (8.0±6.3) mmHg (1 mmHg=0.133 kPa) in dapagliflozin group and (1.0±3.0) mmHg in linagliptin group respectively, the difference was statistically significant (t=7.93, P=0.00); DBP decrease (2.5±2.4) mmHg in dapagliflozin group and (1.0±1.8) mmHg in linagliptin group respectively, the difference was statistically significant (t=3.91, P=0.00). After 24-week treatment, the occurrence of hypoglycemia was similar in dapagliflozin and linagliptin groups [14.1% (10/71) vs 12.9% (9/70), χ²=0.05, P=0.51]. A female urinary tract infection and a male genital infection were reported in dapagliflozin group.

Both dapagliflozin and linagliptin treatment are effective in overweight or obesity type 2 diabetic patients with poor glycemic control of oral antidiabetic drugs. Dapagliflozin is better than linagliptin in controlling of plasma glucose, body weight and blood pressure, and the safety of two groups is similar.

Diabetes mellitus, type 2; Overweight; Obesity; Dapagliflozin; Linagliptin