A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week treatment period assessing the efficacy and safety of lixisenatide in patients with type 2 diabetes insufficiently controlled with basal insulin with or without metformin.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 432
- 试验地点
- 13
- 主要终点
- Absolute change of HbA1c from baseline to week 24.
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled,2-arm parallel-group, multicenter study with a 24-week treatment periodassessing the efficacy and safety of lixisenatide in patients with type 2diabetes insufficiently controlled with basal insulin with or without metforminthat will be conducted in 18 Sites in India. China has 30 Sites, Russia has 7sites and South Korea has 7 sites. The Primary objective is to assess theeffects on glycemic control of lixisenatide in comparison to placebo as anadd-on treatment to basal insulin with or without metformin in terms of HbA1creduction over a period of 24 weeks in insufficiently controlled type 2diabetic patients. The Secondary objective is to assess lixisenatide safety andtolerability, anti-lixisenatide antibodydevelopment and the effects oflixisenatide over 24 weeks on following parameters:
• Percentageof patients reaching HbA1c<7% or ≤6.5%,
• 2-hourpostprandial plasma glucose (PPG) and plasma glucose (PG) excursions duringstandardized meal challenge test,
• Fastingplasma glucose (FPG),
• Change in7-point self-monitored plasma glucose (SMPG) profile,
• Bodyweight,
• Change indaily basal insulin doses,
• Percentageof patients with HbA1c<7% and no symptomatic hypoglycemia, percentage ofpatients with HbA1c<7% and no body weight gain and percentage of patientswith HbA1c<7% and no symptomatic hypoglycemia and no body weight gain.
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
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients with type 2 diabetes mellitus, diagnosed at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin with or without metformin.
- •â€¢Signed written informed consent.
排除标准
- •Age less than legal age of adulthood.
- •HbA1c less than 7% or more than 10.5%.
- •Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
- •If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
- •History of hypoglycemia unawareness.
- •Body Mass Index (BMI) ≤20 kg/m².
- •For complete information, please contact the study team.
结局指标
主要结局
Absolute change of HbA1c from baseline to week 24.
时间窗: week 24.
次要结局
- To assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c7% or ≤6.5%, 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profile), body weight, change in daily basal insulin dose.(week 24)