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临床试验/CTRI/2021/11/037750
CTRI/2021/11/037750招募中3 期

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

Ipca Laboratories Ltd29 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2022年1月2日最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
入组人数
364
试验地点
29
主要终点
To evaluate and compare mean change in glycated hemoglobin (HbA1c) between HCQ group and placebo group
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicentric, randomized, placebo-controlled, double-blind, parallel-group study. A total of 364 patients with type 2 diabetes receiving a stable dose of metformin monotherapy at least 1000 mg/day for at least 12 weeks, weighing ≥ 60 kg, and satisfying the study inclusion/exclusion criteria will be randomized in 1:1:1:1 ratio to receive one of the following treatments for 24 weeks along with an existing dose of metformin (at least 1000 mg/day):

  1. HCQ 200 mg + matching placebo of HCQ 300 mg + matching placebo of HCQ 400 mg
  2. HCQ 300 mg + matching placebo of HCQ 200 mg + matching placebo of HCQ 400 mg
  3. HCQ 400 mg + matching placebo of HCQ 200 mg + matching placebo of HCQ 300 mg
  4. Matching placebo of HCQ 200 mg + matching placebo of HCQ 300 mg + matching placebo of HCQ 400 mg

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 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.

排除标准

  • •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 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 with HCQ 31.Patients receiving drugs known to cause QT prolongation 32.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 33.Patients with substance abuse within the last year 34.Patients consuming alcohol more than 21 units /week 35.Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrolment.
  • •36.Pregnant or lactating women 37.Women of childbearing potential not practicing contraception.

结局指标

主要结局

To evaluate and compare mean change in glycated hemoglobin (HbA1c) between HCQ group and placebo group

时间窗: At Week 24 from baseline

次要结局

  • To evaluate and compare mean change in HbA1c between HCQ group and placebo group(At Week 12 from baseline)
  • To evaluate and compare mean change in fasting blood glucose (FBG) and 2-h post-prandial blood glucose (PPG) between HCQ group and placebo group(At Week 12 and Week 24 from baseline)
  • To evaluate and compare mean change in HbA1c, FBG, and PPG between different treatment groups(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 groups(At Week 24)
  • 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.(Throughout the duration of study)
  • 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)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (29)

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