Assessing the Effectiveness of Hydroxychloroquine on Glycemic Control (HbA1c) in Patients with Type 2 Diabetes Mellitus Uncontrolled on Metformin and Sulfonylurea Combination Therapy (Code: T0012)

Introduction
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by progressive insulin resistance and β-cell dysfunction, often necessitating combination therapies to achieve adequate glycemic control. Hydroxychloroquine (HCQ), commonly utilized in autoimmune diseases, has emerged as a promising agent for improving glycemic and inflammatory markers due to its insulin-sensitizing and anti-inflammatory properties.

Aim and Objectives

Aim: To assess the effectiveness of hydroxychloroquine on glycemic control and inflammatory markers in T2DM patients receiving sulfonylurea and metformin combination therapy.

Objectives:

Primary Objective: To measure the change in HbA1c levels from baseline to week 24 in patients with T2DM.

Secondary Objectives:

To evaluate changes in inflammatory markers, including erythrocyte sedimentation rate (ESR) and highly sensitive C-reactive protein (hs-CRP), from baseline to week 24.

Methods
This non-interventional, single-center study enrolled 120 patients aged ≥18 years with T2DM and HbA1c levels ranging from 8% to 11%. Participants received HCQ (400 mg/day) alongside their existing metformin and sulfonylurea therapy for 16 weeks. Baseline and follow-up evaluations included HbA1c, fasting blood glucose (FBG), postprandial glucose (PPG), ESR, and hs-CRP levels. Statistical analyses were conducted to assess the significance of changes observed during the study period.

Results
The addition of HCQ significantly reduced HbA1c levels by an average of 1.5% (p < 0.001). FBG and 2-hour PPG levels decreased by a mean of 25 mg/dL and 40 mg/dL, respectively. Inflammatory markers (ESR and hs-CRP) also showed substantial improvement, reinforcing HCQ's dual benefits in glycemic and inflammatory control.

Conclusion
Hydroxychloroquine is a valuable add-on therapy for T2DM patients who are inadequately controlled on metformin and sulfonylurea. It provides significant improvements in glycemic parameters (HbA1c, FBG, and PPG) and inflammatory markers (ESR and hs-CRP), thereby enhancing the overall metabolic and inflammatory profile.

Keywords: Type 2 Diabetes Mellitus, Hydroxychloroquine, Glycemic Control, HbA1c, Inflammation, Combination Therapy.