Publication:

Comparison of the efficacy and safety of hydroxychloroquine versus teneligliptin as add on therapy in uncontrolled type 2 diabetes mellitus: a randomized, prospective and open labelled study

Background Type 2 Diabetes Mellitus (T2DM) is a multifactorial metabolic disorder characterized by chronic hyperglycaemia resulting from insulin resistance and β-cell dysfunction. Despite combination therapy with metformin and sulfonylureas, many patients fail to achieve optimal glycemic control, necessitating additional agents. Hydroxychloroquine (HCQS), an immunomodulatory drug, has shown potential antidiabetic and anti-inflammatory effects, while teneligliptin, a DPP-4 inhibitor, improves insulin secretion through incretin modulation.

Methods A randomized, prospective, open-label study was conducted over three months in 100 T2DM patients aged 18–60 years with HbA1c ≥7.5%. Participants received either HCQS 400 mg once daily or teneligliptin 20 mg once daily, in addition to metformin and glimepiride. Fasting blood glucose (FBG), postprandial blood glucose (PPBG), and HbA1c were assessed at baseline, day 28, 56, and 84. Data were analyzed using ANOVA and unpaired t-tests, with p<0.05 considered significant.

Results Both HCQS and teneligliptin significantly (p<0.001) reduced FBG, PPBG, and HbA1c levels from baseline. Comparative analysis showed a greater reduction in HbA1c with HCQS (p<0.05). No significant differences were observed in BMI or incidence of adverse effects between groups. Mild gastrointestinal symptoms were the most common adverse events.

Conclusions Both HCQS and teneligliptin were effective and well-tolerated as add-on therapies in uncontrolled T2DM. HCQS demonstrated superior glycemic improvement, suggesting it as an economical and effective adjunct for better glycemic control in Indian patients.