to evaluate the efficacy of Hydroxychloroquine 300mg in uncontrolled T2DM who are already on two other oral anti diabetic drug.

Efficacy and safety of Hydroxychloroquine 300 mg as an add-on triple Drug in the Treatment of Type 2 Diabetes Mellitus Uncontrolled on Metformin and Glimepiride.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/03/012842

Enrollment

Registered

2018-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- : Patients diagnosed of type 2 diabetes. Patients with HbA1c â?¥7.0 % and â?¤9 %. Patients with body weight â?¥60 kg.

Interventions

Intervention1: Dr. Nihar Ranjan Bhattacharya: Patients diagnosed of type 2 diabetes who are receiving treatment with oral drug metformin 1000 mg/day BD and glimepiride 2mg/day OD are on stable dose fo

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed of uncontrolled type 2 diabetes who are receiving treatment with OAD metformin 1000 mg/day and glimepiride 2mg/day are on stable dose for at least 12 weeks. Patients with HbA1c >=7.0 % and Patients with body weight >=60 kg. Patients able to understand and willing to fully comply with study procedures and restrictions.

Exclusion criteria

Exclusion criteria: Uncontrolled hyperglycemia i.e. FPG >240 mg/dL. Patients with a history or presence of any retinopathy of any grade including diabetic retinopathy requiring laser therapy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuity Patients with recent ( Patient with known history of diabetic ketoacidosis Glucose-6-phophodehydrogenase deficiency Known allergy to the substance, and breastfeeding.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of hydroxychloroquine 300 mg tablets as add-on to triple Drug in the Treatment of Type 2 Diabetes Mellitus Uncontrolled metformin + Glimepiride. The safety will be assessed based on incidence of adverse events, incidence of hypoglycemic events, and changes in laboratory parametersTimepoint: 3 month and 6 months	—

Secondary

Measure	Time frame
The safety will be assessed based on incidence of adverse events, incidence of hypoglycemic events, and changes in laboratory parametersTimepoint: To assess changes in following parameters from baseline to Week 24 of extension period Body weight, Waist circumference and Waist to hip ratio High-sensitivity C-reactive protein (hs-CRP)	—

Countries

India

Contacts

Public ContactNihar Ranjan Bhattacharya

Diabetes, Hypertension, Lipid and Thyroid study and research institute. Kolkata

nihardhlt@rediffmail.com

Outcome results

None listed

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