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 Pharmaceuticals13 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2010年1月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
- 试验地点
- 13
- 主要终点
- Change from baseline in HbA1c after 104 weeks of treatment
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1-4mg daily) given for 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin. The study is designed to show non-inferiority of BI 10773 to glimepiride.Approximately 200 trial sites from 23 countries will participate in this study. Approximately 220 patients will be recruited in India from 12 sites. The first patient from India is expected to be screened on 25 October 2010
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
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.
结局指标
主要结局
Change from baseline in HbA1c after 104 weeks of treatment
时间窗: Baseline and 104 Weeks
次要结局
- Occurrence of Hypoglycaemic events(104 Weeks)
- Occurrence of adverse events of protocol specific significant AEs(104 Weeks)
- Occurrence of Cardiovascular events (Clinical Event Committee adjudication results)(104 weeks)
- Incidence of Adverse events(Baseline and 104 Weeks)
- The change in blood pressure (SBP and DBP)(Baseline and 52 Weeks)
- The change in body weight(Baseline and 52 Weeks)
- The occurrence of confirmed symptomatic hypoglycaemic events(Baseline and 52 Weeks)
研究者
研究点 (13)
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