A Clinical Trial to Study the Safety and Efficacy of Hydroxychloroquine in Patients with Type-2 Daibetes

Evaluation of Safety and Efficacy of Hydroxychloroquine Sulfate as an Adjunct to Diet and Exercise to Improve Glycemic Controll in Type-2 Diabetes Patients Uncontrolled on Sulfonylurea and Metformin Combination

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/02/006599

Enrollment

600

Registered

2016-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Hydroxychloroquine tablets: 400 mg Orally once daily for 52 weeks Control Intervention1: NO Comparator: No Comparator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients receiving stable doses of sulfonylurea and at least 1000 mg dose of metformin for at least 3 months. 2. Patients with HbA1c more than 7 % 3.Patients with ideal body weight of more than 60 kg 4. Patients ready to undergo follow-up of 52 weeks 5. Patients ready to give written, signed and dated informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with other than type 2 diabetes (Type 1 diabetes).2.Patients with a history of any retinopathy of any grade including diabetic retinopathy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuity <20/100, abnormal visual fields, difficulty to examine optic disc, or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema.3.Patients with significant cardiovascular illness limiting participation of patient in a clinical trial.4.Patients receiving/requiring insulin.5.Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.6.Patients with substance abuse will be excluded.7.Pregnant or lactating women.8.Women of childbearing potential not practicing contraception

Design outcomes

Primary

Measure	Time frame
Adverse events (clinical and laboratory) and incidence of hypoglycemiaTimepoint: Through-out the duration of the study including week 4, week 8, week 12,week 24, week 36 and week 52	—

Secondary

Measure	Time frame
Change in HbA1c, FBG,PPGTimepoint: at week 24 and 52;Change in lipid profileTimepoint: at week 24 and 52	—

Countries

India

Contacts

Public ContactDr Ravi Mehta

Ipca Laboratories Ltd.

anil.pareek@ipca.com

Outcome results

None listed

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