CTRI/2016/02/006599
Recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
- Sponsor
- Ipca Laboratories Ltd
- Enrollment
- 600
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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