CTRI/2010/091/000151未知2 期
A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline Diabetes Therapies
试验速览
- 阶段
- 2 期
- 入组人数
- 244
- 试验地点
- 8
- 主要终点
- Evaluate canakinumab effects on change from baseline of meal challenge derived insulin secretion rate relative to glucose at 4 weeks for each population
研究概览
简要总结
Planned number of patients from India is 60.Planned FPFV is 21st April 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •1.Patient must fulfill all criteria in one of the following groups:* Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study * Diagnosis of Type 2 diabetes in stable treatment with metformin * Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea * Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy * Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin 2.HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group 3.Age from 18-74 years, inclusive, and of either sex.
排除标准
- •1.Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes 2.History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol: 3.Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.
结局指标
主要结局
Evaluate canakinumab effects on change from baseline of meal challenge derived insulin secretion rate relative to glucose at 4 weeks for each population
时间窗: 4 weeks
次要结局
- * Evaluate the effect on change from baseline of other meal challenge derived parameters, including insulin, glucose and other glycemic control parameters(4 weeks)
- * Provide information on canakinumab effects on improving glucose parameters in people with impaired glucose tolerance(4 weeks)
- * Assess safety and tolerability for all study populations(4 weeks)
研究者
研究点 (8)
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