Evaluation of Efficacy and Safety of Hydroxychloroquine in Patients with Type 2 Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/03/023714
- Lead Sponsor
- Ipca Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients diagnosed with type 2 diabetes mellitus who are receiving stable dose of metformin (>=1000 mg/day to <=2000 mg/day) and glimepiride (at least 2 mg/day)/gliclazide (at least 160 mg/day of immediate release formulation or at least 60 mg/day of modified release formulation) for at least 12 weeks
2.Patients with HbA1c between 7.5 % and 10.5 % (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
1.Patients with uncontrolled hyperglycemia i.e. FPG >240 mg/dL
2.Patients with Type 1 diabetes
3.Patients with endocrine disorder 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 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.
6.Patients with abnormal renal function (Serum creatinine >= 1.5 mg/dL for male and >= 1.4 mg/dL for female)
7.Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.0 times the upper limit of normal values) or active or chronic liver disease or patients with CPK >2.0 times the upper limit of normal value
8.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
9.Patients with triglycerides >= 500 mg/dL
10.Patients with history of G6PD deficiency, aplastic anemia or agranulocytosis, granulocytopenia
11.Patients with history of psoriasis, blisters, porphyria, rash, scaling, scaling eczema
12.Patients with history of myalgia, proximal myopathy, neuropathy including symptomatic autonomic neuropathy
13.Patient with history of neuropsychiatric events, including suicidality
14.Patients with hs-CRP >= 10 mg/L
15.Patients with systolic BP >180 mmHg and/or diastolic BP >100 mmHg
16.Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer)
17.Patient with known history of diabetic ketoacidosis
18.Patients with history of hypoglycemia unawareness (Patients whose blood glucose levels fall below 70 mg/dL but they do not feel any symptoms of hypoglycemia)
19.Patients with malignancy and planned radiological examinations requiring administration of contrasting agents
20.Patients with malabsorption or pancreatitis
21.Patients with dementia or other cognitive impairment prohibiting informed consent
22.Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
23.Patient with any other illness for which hydroxychloroquine is indicated (such as rheumatoid arthritis, systemic lupus erythematosus [SLE])
24.Patients with any other clinically significant abnormalities/disease which may or may not interfere with assessment of disease under evaluation
25.Patients receiving/requiring insulin
26.Patients receiving anti-obesity drugs or undergoing bariatric surgery within 24 weeks prior to consent
27.Patients receiving systemic steroids at the time of consent or have received it in past 3 months
28.Patients with chronic use of non-steroidal anti inflammatory agents
29.Patients receiving concomitant medications known to have an interaction with HCQ
30.Patients receiving drugs known to
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate mean change in glycated hemoglobin (HbA1c) in HCQ 200 mg group <br/ ><br>2.To evaluate mean change in HbA1c in HCQ 300 mg group <br/ ><br>3.To evaluate mean change in HbA1c in HCQ 400 mg groupTimepoint: At Week 24 from baseline
- Secondary Outcome Measures
Name Time Method