CTRI/2008/091/000035已完成2 期
Assessment of safety and efficacy of biphasic human insulin IU 100 to EX1000 on glycaemic control in subjects with type 2 diabetes.
ovo Nordisk India Private Limited AS0 个研究点目标入组 224 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
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
- •1. Type 2 diabetes for at least 12 months
- •2. Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
- •3. Body Mass Index (BMI) less than or equal to 40.0 kg/m2
- •4. HbA1c less than or equal to 9.5%
- •5. FPG (SMPG) less than or equal to 12 mmol/L
- •6.Age 18 years and older.
排除标准
- •1. Treatment with more than 1IU/kg insulin daily
- •2. Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- •3. Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
- •4. Known or suspected allergy to trial products or related products
- •5. Receipt of any investigational drug within one month prior to this trial
- •6. Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
研究者
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