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 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2
- 发起方
- ovo Nordisk India Private Limited AS
- 入组人数
- 224
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
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
结局指标
主要结局
未指定
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