CTRI/2021/11/037750
Recruiting
Phase 3
Evaluation of Efficacy and Safety of Hydroxychloroquine when Used as an Add-on Therapy in Type 2 Diabetes Patients Uncontrolled on Metformin Monotherapy: A Randomized Double-blind, Placebo-controlled Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Sponsor
- Ipca Laboratories Ltd
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients diagnosed with T2D who are receiving stable dose of metformin (\>\=1000 mg/day) for at least 12 weeks
- •2\.Patients with HbA1c between 7\.0 % and 10 % (Both inclusive)
- •3\.Patients with FPG \>125 mg/dL and/or PPG \>\=200 mg/dL
- •4\.Patients with body weight \>\=60 kg
- •5\.Patients able to understand and willing to fully comply with study procedures and restrictions
- •6\.Patient ready to give informed consent to participate in the study
Exclusion Criteria
- •1\.Patients with uncontrolled hyperglycemia i.e. FBG \>240 mg/dL
- •2\.Patients with Type 1 diabetes
- •3\.Patients with endocrine disorders other than Type 2 diabetes mellitus
- •4\.Patients with a history or presence of any retinopathy of any grade including diabetic retinopathy, evidence of an imminent need for 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
- •5\.Patients with QT prolongation (\>\=450 ms), ventricular arrhythmia or torsades de pointes
- •6\.Patients with cardiovascular events i.e. myocardial infarction/acute coronary syndrome, stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or transient ischemic attack, or history of congestive heart failure, cardiomyopathy or unstable angina in past
- •7\.Patients with abnormal renal function (serum creatinine \>\=1\.5 mg/dL for male and \>\=1\.4 mg/dL for female)
- •8\.Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase \>2\.5 times the upper limit of normal values) or active or chronic liver disease or patients with CPK \>2\.5 times the upper limit of normal value
- •9\.Patients with significantly abnormal counts in hematology, diseases of blood or hematopoietic organs or female patients with Hb \<10 g/dL or male patients with Hb \<12 g/dL
- •10\.Patients with triglycerides \>\= 500 mg/dL
Outcomes
Primary Outcomes
Not specified
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