Aim: The aim of this study was to compare the efficacy and safety of fixed-dose combination (FDC) of pioglitazone and metformin supplemented with dapagliflozin (test group) with those of basal insulin supplemented with metformin (control group) in patients with inadequately controlled type 2 diabetes mellitus (T2DM) . Methods: This 16-week, prospective, randomized, open-label study enrolled patients aged 18-75 years with glycated hemoglobin (HbA1c) levels between >= 8% and <= 11%. The primary endpoint was the proportion of patients who achieved HbA1c < 7% at week 16 without hypoglycemia or weight gain. The secondary endpoints included blood glucose, lipid profile, body weight, body mass index, inflammatory markers, bone Gla-protein, liver enzymes, and patient satisfaction. Results: Among the full analysis set of 147 participants, no significant difference was observed in the primary endpoint between the test group and the control group. However, the test group had a higher percentage of patients who achieved HbA1c <7% at week 16 without hypoglycemia and experienced a weight loss of >= 3% (31.51% vs 13.51%, P=0.009). Patients in the test group whose BMI >= 24 kg/m2 also achieved a substantial achievement rate (36.73% vs 15.79%, P=0.014). The test group also exhibited a greater reduction in body weight and improvements in 2-hour postprandial glucose level, systolic blood pressure, and lipid profile. Notably, combination therapy did not increase the risk of hypoglycemia or weight gain. Patients in the test group were more satisfied than those in the control group with continuing to accept pioglitazone/metformin FDC combined with dapagliflozin. Conclusion: In the absence of contraindications, pioglitazone/metformin FDC supplemented with dapagliflozin may serve as a safe and effective alternative to basal insulin combined with metformin for rectifying inadequate glucose control, as the former enables metabolic improvements without compromising safety.
[1]Shanghai Jiao Tong Univ, Shanghai Gen Hosp, Dept Endocrinol & Metab, Shanghai, Peoples R China.
[2]Fengxian Dist Cent Hosp, Shanghai 201400, Peoples R China.
[3]Fudan Univ, Huadong Hosp Affiliated, Shanghai, Peoples R China.
[4]Shanghai Jiading Cent Hosp, Shanghai 201800, Peoples R China.
[5]Anhui Med Univ, Chaohu Hosp, Chaohu, Peoples R China.
[6]Affiliated Fudan Univ, Dept Dermatol, Qingpu Branch, Shanghai 201700, Peoples R China.
[7]Shanghai Univ, Seventh Peoples Hosp, Shanghai, Peoples R China.
[8]Cent Hosp Xian, Xian, Peoples R China.
[9]Wuhan Fourth Hosp, Wuhan, Peoples R China.
[10]Tongji Univ, Dongfang Hosp, Shanghai 200092, Peoples R China.
[11]Shanghai Jiaotong Univ Sch, Dept Ophthalmol, Shanghai, Peoples R China.
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