NCT02303405终止2 期
Comparing the Effects of Hydroxychloroquine (HCQ) to Pioglitazone in Type 2 Diabetic Patients Failing Maximal Doses of Metformin Plus a Sulfonylurea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea.
详细描述
A 4-month, randomized, prospective, open-label comparison trial of 4 months of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-75, inclusive
- •Known type 2 diabetes (diagnosed according to 1997 ADA diagnostic criteria)
- •At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea
- •Hemoglobin A1c ≥ 7.5% and < 11.0%
- •Body mass index (BMI) < 45 kg/m2
- •Able to comply with all scheduled visits and requirements of the protocol
排除标准
- •Any contraindications to the use of metformin or a sulfonylurea
- •Extreme hyperglycemia (FPG ≥ 300 mg/dL), symptoms of polyuria or polydipsia, or Hemoglobin A1c ≥ 11.0%
- •Current use of insulin; history or clinical suspicion of type 1 diabetes mellitus
- •Symptomatic hypoglycemia occurring at an average frequency > once per day
- •Highly erratic dietary schedules, extremely food insecure households, or homelessness that may adversely affect good glycemic control, as judged by the investigators
- •Occupations that involve regular operation of motor vehicles or other heavy machinery that may pose a hazard in the event of unanticipated blurred vision
- •Known history of Class III or IV heart failure, cardiac arrhythmias, severe peripheral edema, advanced osteoporosis, documented bladder malignancies, or other intolerance to pioglitazone
- •Known history of collagen vascular disorders, glucose-6-phosphate dehydrogenase deficiency, hematologic disorders, psoriasis, or any known intolerance to hydroxychloroquine
- •Known history of pre-proliferative or proliferative retinopathy, or any clinically significant retinal abnormalities noted on the patient's most recent (i.e., within 1 year) ophthalmologic exam; subjects who have not received their routine annual ophthalmologic surveillance for diabetic retinopathy within the past year must have their annual surveillance performed before screening
- •An estimated GFR (by the Modification of Diet in Renal Disease (MDRD) formula) < 45 mL/min, or a history of nephrotic syndrome (defined as a spot urine protein-creatinine ratio of > 3500 mg per g urine creatinine)
- •Subjects with active hemoglobin abnormalities that render the Hemoglobin A1c measurement unreliable
- •History of any clinically significant hepatic, cardiovascular, infectious, dermatologic, psychiatric, or other major systemic disease that, in the opinion of the investigator, may make the use of pioglitazone or hydroxychloroquine unsafe, or otherwise make the interpretation of the data difficult.
- •Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception or do not agree to use a reliable form of contraception. Reliable forms of contraception include systemic contraceptives (oral, implant or injection), diaphragm with spermicide, cervical cap, IUD, or condoms with spermicide.
- •Current pregnancy or lactation.
- •Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study (e.g., glucocorticoids).
- •Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
- •Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
研究组 & 干预措施
Hydroxychloroquine
Experimental
Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months
干预措施: Hydroxychloroquine (Drug)
Pioglitazone
Active Comparator
Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Hemoglobin A1c
时间窗: 4 months
Glycemic control
次要结局
- Fasting Plasma Glucose(4 months)
- Percent of Subjects Achieving HbA1c < 7.5%(4 months)
- Weight(4 months)
- Body Mass Index(4 months)
- HOMA-IR(4 months)
- QUICKI(4 months)
- Hs-CRP(4 months)
- Leucocyte Count(4 months)
- Hypoglycemic Events(4 months)
- Adverse Events(4 months)
研究者
研究点 (1)
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