To compare the effectiveness of hydroxychloroquine vs vildagliptin in type-2 diabetes mellitus patients

Phase 4

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2023/01/049173
• Lead Sponsor: BPS Govt medical college

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adult subjects more than 18 years of age of either sex suffering from T2DM and, taking metformin(2000mg) plus Glimepiride(2mg) for >=3 months.

2.Patients with glycated hemoglobin (HbA1c) levels>= 7.5 %

3.Fasting hyperinsulinemia ( >7 μU/mL).

4.Willing to give written informed consent for the study.

Exclusion Criteria

1.Subjects who will not give written consent to participate.

2.Subjects with a history of retinopathy.

3.Subjects with uncorrected visual acuity pigment, epithelial abnormalities, and history or risk of macular edema.

4.History or risk of psoriasis, rash, scaling or scaling eczema, porphyria.

5.Corticosteroid use at present or in the previous 6 months.

6.Medications that affect glucose metabolism e.g., Thiazide, cyclosporine, tacrolimus, oral contraceptive pills, nicotinic acid, thyroxine, diazoxide etc.

7.Medication that affects lipid metabolism e.g., statin groups, fibrates, niacin etc.

8.Patients with abnormal Kidney function test (KFT) and Liver function test (LFT).

9.Anemic patients (Hemoglobin of less than 10 g/dL).

10.Pregnant or lactating women.

11.Subjects with a history of allergic reactions to hydroxychloroquine, vildagliptin, metformin, glimepiride.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HOMA-IR (Homeostatic model assessment-insulin resistance), KIER Scoring,Timepoint: baseline, 8 weeks, 16 weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Glycated hemoglobin(HbA1c),Metabolic syndrome severity score(MetSSS) Fasting plasma glucose(FPG), post-prandial plasma glucose(PPG), Lipid profile, Body mass index(BMI), Waist circumference, Blood pressure(BP) <br/ ><br>Timepoint: 24 weeks