CTRI/2009/091/001036已完成3 期
Efficacy and safety of Hydroxychloroquine in the Treatment of Type II Diabetes Mellitus: A Double Blind, Randomized Comparison with Pioglitazone
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 17
- 主要终点
- Mean change in FBG, PPG and HbA1C
研究概览
简要总结
This study is a randomized, double blind, parallel group, multicentre trial comparing the safety and effecacy of hydroxychloroquine 400 mg and pioglitazone 15 mg in patients with type II diabetes mellitus.In this study, patients receiving gliclazide/glimepiride+ metformin with uncontrolled type II diabetes will undergo a pre run-in period of upto 1 month (if required), followed by run-in period (compulsory for 3 months). Patients uncontrolled after run-in period will be randomized to receive either hydroxychloroquine 400 mg or pioglitazone 15 mg for 6 months in addition to the previous therapy that they were receiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed of type II diabetes defined by ADA criteria and are uncontrolled by combination therapy of two oral hypoglycemic agents i.e. either metformin greater than or equal to 1000mg/day in combination with glimepiride greater than or equal to 4mg/day or gliclazide greater than or equal to 160mg/day combination
- •Patients with HbA1c greater than or equal to 7.5 % and less than or equal to 11.5 % at baseline visit (HbA1C 7.5 % and less than or equal to 11.5 % for screening visit)
- •Patients with body weight greater than or equal to 60 kg
- •Patients willing and likely to fully comply with study procedures and restrictions and ready to give written informed consent.
排除标准
- •Patients with other than Type II diabetes
- •Patients with a history of any retinopathy including diabetic retinopathy
- •Patients with abnormal renal and liver function.
- •Patients with disease of blood or haematopoetic organs
- •Patient with known history of diabetic ketoacidosis
- •Patients receiving insulin therapy
- •Patients with known history of hypersensitivity to hydroxychloroquine, glimepiride, gliclazide, metformin , pioglitazone or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of severe allergic disease
- •Pregnant or lactating women.
- •Women of childbearing potential not practicing contraception.
结局指标
主要结局
Mean change in FBG, PPG and HbA1C
时间窗: At week 12 and week 24 from baseline
次要结局
- Clinical improvement in terms of HbA1c, FBG and PPG levels, To assess the safety and tolerability of test product as compaired to reference product characterised by changes in liver function test opthalmologic changes at week 12 and week 24 post randomization.(at week 12 and week 24)
研究者
研究点 (17)
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