Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks
研究概览
简要总结
The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included
排除标准
- •Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.
- •Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered
研究组 & 干预措施
Group 1
Acarbose_BAY G5421
干预措施: Bay G5421 Glucobay (Drug)
Group 2
Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks
时间窗: baseline and 16 weeks
The primary outcome will be summarized separately in acarbose and metformin monotherapy treated patients having carbohydrates consumption (National Institute of Nutrition (NIN), India recommend50% to 60% of total calories from carbohydrates in balance diet : - Below NIN recommendation (\< 50%) - As per NIN recommendation (50% to 60%) - Above NIN recommendation (\> 60%)
次要结局
- Mean change of HbA1c(Baseline and 16 weeks)
- Mean change of high density lipoprotein cholesterol(HDL)(Baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of LDL(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of TG(baseline and 16 weeks)
- Mean change of triglyceride(TG)(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of HbA1c(baseline and 16 weeks)
- Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks(baseline and 16 weeks)
- Mean change of fasting blood glucose(FBG)(Base line and 16 weeks)
- Mean change of Body weight(baseline and 16 weeks)
- Mean change of low density lipoprotein cholesterol(LDL)(baseline and 16 weeks)
- Mean change of total cholesterol(TC)(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of HDL(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of FBG(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of Body weight(baseline and 16 weeks)
- Compare the mean change between acarbose and metformin arm of TC(baseline and 16 weeks)
- Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period(16 weeks)