Abstract

EVALUATION OF SAFETY AND EFFICACY OF HYDROXYCHLOROQUINE SULFATE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN TYPE 2 DIABETES PATIENTS UNCONTROLLED ON SULFONYLUREAS + METFORMIN COMBINATION

Anil Pareek*, Nitin Chandurkar and Kumar Naidu

.

Abstract

Purpose: To evaluate safety and efficacy of hydroxychloroquine (HCQ) in uncontrolled type 2 diabetes (T2D) patients receiving sulfonylureas+metformin combination. Methods: This prospective, multicentric, phase 4 study with 747 T2D patients uncontrolled (HbA1c≥7%) on sulfonylureas+metformin combination enrolled to receive add on HCQ 400 mg/day for 52 weeks. The modified intention to treat population comprised of 609 cases and 457 cases of per protocol population. Effects on glycemic, lipid and inflammatory parameters were assessed. Results: Significant fall in glycemic and lipid parameters were seen. Patients were divided based on their baseline hsCRP levels (≤3 and >3). There was significant fall in all parameters at week 24 & 52 irrespective of baseline hsCRP. However, fall in A1C was significantly more at week 12 and 24 in high inflammatory load (p

Keywords: Glycemic control; Hydroxychloroquine; Metformin; Sulfonylureas; Type 2 Diabetes.