CTRI/2010/091/001212已完成3 期
A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment
Boehringer Ingelheim Pharmaceuticals0 个研究点目标入组 1,400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
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
- •Inclusion Criteria:
- •1)Diagnosis type 2 diabetes mellitus,
- •2) male and female on diet and exercise regimen, drug naive or pre-treated with metformin 12 weeks prior to randomisation,
- •3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1,
- •4) 18 years or more (Restricted to patients <= 65 years of age as per upper age limit imposed by the DCG(I) for patients recruited in India),
- •5) BMI equal or less than 45Kg/m2.
排除标准
- •Exclusion Criteria:
- •1)uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in,
- •2)any other antidiabetic drug within 12 weeks prior to randomisation except metformin,
- •3) myocardial infarction, stroke or transient ischemic attack within 12 weeks of informed consent,
- •4) indication liver disease,
- •5)moderate to severe renal impairment,
- •6)bariatric surgery within past 2 years,
- •7)medical history of cancer or treatment for cancer within last 5 years,
- •8)blood dyscrasias or any disorders causing haemolysis or unstable red blood cell,
- •9)contraindications hypersensitivity to concomitant drugs,
- •10) treatment with anti-obesity drugs
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