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

Phase 4

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

Registration Number: CTRI/2016/02/006599

Lead Sponsor: Ipca Laboratories Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 600

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures