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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
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