Low dose pioglitazone (7.5 mg) provides efficacious glycemic control in Asian Indian patients with poorly controlled diabetes compared to 15 mg: A pilot randomized controlled parallel-group open-label trial over 12 months.

AIMS: We aimed to compare the 1-year efficacy and safety of 7.5 mg versus 15 mg pioglitazone in Asian Indian patients with type 2 diabetes due to lack of long-term data in lower doses.

METHODS

In this open-label randomized controlled study, 60 patients were assigned to receive either 7.5 mg or 15 mg of pioglitazone daily. Efficacy endpoints included HbA1c, fasting and postprandial venous glucose. Additionally, lipid profile, liver enzymes, and DXA-based body composition, BMD, weight gain, hemoglobin, and adverse events were performed.

RESULTS

Both doses achieved significant HbA1c reduction from baseline (-0.95 % in 7.5 mg, -0.9 % in 15 mg) and postprandial venous glucose (median absolute difference -50 and -46 mg/dl), with non-inferiority of the lower dose. Weight gain occurred in both groups (0.95 kg vs 1.3 kg), mainly due to increased fat mass, with a trend toward greater and earlier gain in the 15 mg arm. Lipid parameters, hepatic enzymes, and body composition parameters were comparable across arms, while there was significant reduction in SGOT and VLDL within individual groups. No significant differences in hypoglycemia, edema, BMD loss, or fractures were observed. The major limitations of the study were open label design, single tertiary care center setting, imperfect randomization in fasting glucose, LDL, and total cholesterol between groups and missing data in DXA scan at follow up.

CONCLUSION

Pioglitazone 7.5 mg is an effective and well-tolerated alternative to 15 mg in Asian Indian patients with type 2 diabetes.

CLINICAL TRIALS REGISTRY OF INDIA REGISTRATION NUMBER: CTRI/2021/09/036149.