Randomized placebo controlled study of the effect of Ranolazine on HbA1c level in Type 2 diabetes mellitus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c at Week 12
研究概览
简要总结
Diabetes mellitus has become endemic in India.It predisposes to microvascular, macrovascular complications leading to coronarysyndromes , cerebrovascular accidents, retinopathy, nephropathy, & and manyother diseases.
Ranolazine – a drug approved to be used in coronarysyndromes, showed to improve glycemic control in CARISA TRIAL. Mechanism ofaction of glycemic control is yet to be explored.
So a study is planned to evaluate the effect ofranolazine on HbA1c, fasting glucose, serum insulin, & C-Peptide. The studydesign would be a randomized placebo controlled trial. Study population wouldbe patients attending diabetic clinic of IPGME&R & SSKM Hospital,Kolkata. Target sample size will be 34 patients in each group suffering fromtype 2 Diabetes currently on non-insulinantidiabetic therapy (Metformin) inaddition to diet and exercise.
After obtaining written informed consent from eitherpatient, subjects would be randomly allocated to two groups – one to receiveranolazine and the other to receive placebo as add on to standard oralhypoglycemic medication (Metformin).
Data would be analyzed in the Department ofPharmacology, IPGME&R and the results will be compiled into the doctoralthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢18 to65 years old •Subjects with T2DM currently on non-insulin antidiabetic therapy (metformin) in addition to diet and exercise •Body mass index (BMI) ≥ 20 kg/m2 and ≤ 35 kg/m2 •HbA1c
- •10% •Female of child-bearing potential must agree to use effective methods of contraception •Signed written informed consent.
排除标准
- 未提供
结局指标
主要结局
Change from baseline in HbA1c at Week 12
时间窗: 12 weeks
Change from baseline in 2-hour postprandial serum glucose at Week 12
时间窗: 12 weeks
Change from baseline in fasting serum glucose at Week 12
时间窗: 12 weeks
次要结局
- Change from baseline in fasting serum C-peptide at Weeks 12(Change from baseline in fasting serum insulin at Weeks 12)