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

Efficacy and safety of hydroxychloroquine vs vildagliptin as an add-on therapy to metformin and glimepiride in adult patients with uncontrolled type-2 diabetes mellitus: A randomized controlled clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049173

Enrollment

126

Registered

2023-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Metformin (1000 mgÃ?bd) before meal, Glimepiride (2 mgÃ?od) before meal, Hydroxychloroquine (400 mgÃ?od) after meal: Intervention group will have 63 patients and receive the above treat

Eligibility

Inclusion criteria

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 Î¼U/mL). 4.Willing to give written informed consent for the study.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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) Timepoint: 24 weeks	—

Countries

India

Contacts

Public ContactDr Satya Ranjan Mishra

BPS govt. medical college

drrahulnanu@gmail.com9813415848

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026