A Prospective, Multicentric, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM
研究概览
简要总结
This is a multicentre, randomized, open label study on comparison of change in HbA1c between Glargine OD + Glulisine and Premixed insulin in insulin naïve patients for 24 weeks in 200 patients with T2DM. This study will be conducted in seven centres in Chennai. The primary outcome measures will be to compare the effects of Glargine OD + Glulisine versus Premixed insulin on changes in HbA1c in insulin naïve T2DM patients at 24 weeks. The secondary outcomes will be effect of Glargine OD + Glulisine versus Premixed insulin based treatment on fasting blood glucose, postprandial blood glucose, 7-point self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%, Insulin dose, Overall adverse events, Weight, BMI, Blood pressure, Symptomatic Hypoglycemia and Severe hypoglycemic at 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Insulin naïve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months
- •Both men and women of age more than or equal to 18 and less than or equal to 65 years
- •Have an HbA1c more than or equal to 7.5% and less than or equal to 10.5% with fasting blood glucose more than or equal to 150 mg/dl and/or Postprandial blood glucose more than or equal to 200 mg/dl
- •Body mass index less than or equal to 40 kg/m2
- •Have given written informed consent to participate in this study in accordance with local regulations
- •Subject must have access to telephone for calling into the clinical center as part of test product compliance.
排除标准
- •Type 1 diabetes
- •BMI more than 40 kg/m2
- •Subject is being treated for severe active infection of any type
- •Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study
- •Planned surgery in the next 6 months
- •Any event forecasted to require a temporary need to switch to insulin.
结局指标
主要结局
To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM
时间窗: 24 weeks
次要结局
- Fasting plasma glucose(24 weeks)
- Severe Hypoglycemia(24 weeks)
- Weight(24 weeks)
- Body Mass Index(24 weeks)
- Postprandial glucose(24 weeks)
- 7-point self-monitored blood glucose (SMBG) profiles(24 weeks)
- Overall adverse events(24 weeks)
- Symptomatic Hypoglycemia(24 weeks)
- Percentage of participants with HbA1c less than 7%(24 weeks)
- Insulin Dose(24 weeks)
- Blood pressure(24 weeks)