CTRI/2020/03/023714招募中3 期
A Randomized, Double-blind, Parallel Arm, Dose Optimization Study to Assess Efficacy and Safety of Hydroxychloroquine in Type 2 Diabetes Patients Uncontrolled on Metformin and Sulfonylurea Combination
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 213
- 试验地点
- 24
- 主要终点
- 1.To evaluate mean change in glycated hemoglobin (HbA1c) in HCQ 200 mg group
研究概览
简要总结
This is a randomized, double blind, parallel arm, comparative, multicentric, dose optimization study. A total of 213 patients with type 2 diabetes, receiving at least 1000 mg/day to maximum 2000 mg/day of metformin in combination with 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) and following routine diet and exercise regime for at least 12 weeks, and satisfying the study inclusion/exclusion criteria will be enrolled in this study. All eligible patients will be divided into one of the three groups in 1:1:1 ratio at baseline/randomization/enrollment visit (Week 0) to receive one of the following 3 treatments:1. HCQ 200 mg + Matching placebo of HCQ 300 mg and 400 mg for 24 weeks
2. HCQ 300 mg + Matching placebo of HCQ 200 mg and 400 mg for 24 weeks
3. HCQ 400 mg + Matching placebo of HCQ 200 mg and 300 mg for 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 cause QT prolongation 31.Patients with known history of hypersensitivity to HCQ, or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of any severe allergic disease.
- •32.Patients with substance abuse within the last year 33.Patients consuming alcohol more than 21 units /week 34.Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.
- •35.Pregnant or lactating women.
- •36.Women of childbearing potential not practicing contraception.
结局指标
主要结局
1.To evaluate mean change in glycated hemoglobin (HbA1c) in HCQ 200 mg group
时间窗: At Week 24 from baseline
2.To evaluate mean change in HbA1c in HCQ 300 mg group
时间窗: At Week 24 from baseline
3.To evaluate mean change in HbA1c in HCQ 400 mg group
时间窗: At Week 24 from baseline
次要结局
- To evaluate mean change in HbA1c in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups
- To evaluate mean change in fasting plasma glucose (FPG) and 2-hr postprandial plasma glucose (PPG) in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups(At Week 12 and Week 24 from baseline)
- To evaluate mean change in lipid profile (total cholesterol [TC], triglyceride [TG], high density lipoprotein-cholesterol [HDL-C], low density lipoprotein-cholesterol [LDL-C] and non-HDL-C) in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups(At Week 12 and Week 24 from baseline)
- To evaluate mean change in body weight, body mass index (BMI), waist circumference and waist to hip ratio in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups(At Week 12 and Week 24 from baseline)
- To evaluate mean change in high-sensitivity C-reactive protein (hs-CRP), white blood cells (WBC) and erythrocyte sedimentation rate (ESR) in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups(At Week 24 from baseline)
- To evaluate percentage of patients achieving HbA1c level 7.0% in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups(At Week 24)
- To assess the safety and tolerability of study medications based on incidence of adverse events (AEs) (clinical and laboratory), changes in laboratory parameters and incidence of hypoglycemia(Throughout the duration of study)
研究者
研究点 (24)
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