Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Hydroxychloroquine: Hydroxychloroquine 200 mg, 300 mg and 400 mg
administered once daliy for 24 weeks with existing
dose of metformin
Control Intervention1: Placebo: Matching placebo of
Sponsors
Ipca Laboratories Ltd
Eligibility
Inclusion 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
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 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. Patients with triglycerides >= 500 mg/dL 11. Patients with history of G6PD deficiency, aplastic anemia or agranulocytosis, granulocytopenia 12. Patients with history of psoriasis, blisters, porphyria, rash, scaling, scaling eczema 13. Patients with history of myalgia, proximal myopathy, neuropathy including symptomatic autonomic neuropathy 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. Patients 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 HCQ is indicated (such as rheumatoid arthritis [RA], systemic lupus erythematosus [SLE] etc.) 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 other OHA 27. Patients receiving anti-obesity drugs or undergoing bariatric surgery within 24 weeks prior to consent 28. Patients receiving systemic steroids at the time of consent or have received it in past 3 months 29. Patients with chronic use of non-steroidal anti inflammatory agents 30. Patients receiving concomitant medications known to have an interaction wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare mean change in glycated hemoglobin (HbA1c) between HCQ group and placebo groupTimepoint: At Week 24 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of study medications based on incidence of adverse events AEs clinical and laboratory, changes in laboratory parameters and incidences of hypoglycemia.Timepoint: Throughout the duration of study;To evaluate and compare mean change in fasting blood glucose (FBG) and 2-h post-prandial blood glucose (PPG) between HCQ group and placebo groupTimepoint: At Week 12 and Week 24 from baseline;To evaluate and compare mean change in following parameters Total Cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and non HDL-C Body weight, BMI, waist circumference and waist to hip ratio High-sensitivity C-reactive protein (hs-CRP), white blood cells (WBC) and erythrocyte sedimentation rate (ESR)Timepoint: At Week 12 and Week 24 from baseline;To evaluate and compare mean change in HbA1c between HCQ group and placebo groupTimepoint: At Week 12 from baseline;To evaluate and compare mean change in HbA1c, FBG, and PPG between different treatment groupsTimepoint: At Week 12 and Week 24 from baseline;To evaluate and compare percentage of patient achieving HbA1c level less than 7.0 percent between treatment groupsTimepoint: At Week 24 | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Ltd.
Outcome results
None listed