TYPE 2 diabetes (T2D) remains a global healthcare challenge, with significant long-term complications if poorly managed. A recent study found that the combination of a pioglitazone/metformin fixed-dose combination (FDC) supplemented with dapagliflozin provided effective glycaemic control, weight loss, and metabolic improvements in patients with T2D, offering a promising alternative to basal insulin with metformin.
This prospective, randomised, open-label trial compared the efficacy and safety of a 16 week treatment of pioglitazone/metformin FDC (15 mg / 500 mg) taken three times daily with 5 mg dapagliflozin (increased to 10 mg after the first week) taken once daily, to basal insulin with metformin (500 mg) taken three times daily. The study focused on adults aged 18–75 years with inadequately controlled glycaemia, represented by HbA1c levels between 8.0% and 11%. The primary endpoint was achieving HbA1c <7% without hypoglycaemia or weight gain, and secondary outcomes included blood glucose, body weight, blood pressure, lipid profiles, and patient satisfaction.
A total of 147 patients participated, (test group [n=73 participants], control group [n=74 participants]) with no significant difference in the primary endpoint between the two groups, as 32 (43.84%) of the test group and 28 (37.84%) of the control group reached the HbA1c target, without hypoglycaemic events or weight gain. However, a significantly higher percentage of patients in the test group achieved HbA1c <7% and lost ≥3% of body weight without hypoglycaemic events) compared to the control group (23 [31.51%] vs 10 [13.51%]; p=0.009). Furthermore, in patients with a BMI ≥24, 18 (36.73%) in the test group achieved the HbA1c target and lost ≥3% of body weight (without hypoglycaemic events) compared to 9 (15.79%) in the control group (p=0.014). Additionally, improvements in the test group were observed in blood pressure, lipid profiles, and liver enzymes.
The study suggests that pioglitazone/metformin FDC with dapagliflozin could offer a viable treatment option for managing T2D, particularly for patients with higher BMIs who may benefit from both metabolic and weight loss benefits. However, the study has limitations, including a small sample size, and lack of control over diet and physical activity. Considering these limitations, further research is needed to investigate the mechanisms and long-term effects of this treatment combination, notably regarding weight loss parameters.
Reference
Lin Y et al. Enhancing Diabetes Treatment: Comparing Pioglitazone/Metformin with Dapagliflozin Versus Basal Insulin/Metformin in Type 2 Diabetes. Drug Des Devel Ther. 2025;19:1795-808
