A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 978
- 试验地点
- 136
- 主要终点
- Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period
研究概览
简要总结
Primary objective:
To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents
Secondary objectives of the comparative period (24 weeks):
>To assess the effect of insulin glargine in comparison with liraglutide on:
- HbA1c level
- Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period
- Percentage of patients whose HbA1c has increased at the end of the comparative period
- Fasting Plasma Glucose (FPG)
- 7-point Plasma Glucose (PG) profiles
- Hypoglycemia occurrence
- Body weight
- Adverse events
Objectives of the extension period (24 weeks):
>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:
- HbA1c level
- FPG
- 7-point PG profiles
- Hypoglycemia occurrence
- Body weight
- Adverse events
详细描述
Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:
- A 2-week of screening period,
- A 24-week comparative period,
- A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period),
- A 1-week follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Insulin Glargine
Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study.
The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 < FPG ≤ 100 mg/dL (3.9 < FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.
干预措施: Insulin glargine (Drug)
Insulin Glargine
Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study.
The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 < FPG ≤ 100 mg/dL (3.9 < FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.
干预措施: Metformin (Drug)
Liraglutide
Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study.
The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.
干预措施: Liraglutide (Drug)
Liraglutide
Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study.
The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.
干预措施: Metformin (Drug)
结局指标
主要结局
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period
时间窗: week 12, week 24
The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward \[LOCF\] value).
次要结局
- Daily Dose of Insulin Glargine(week 1, week 2, week 6, week 12, week 24)
- Body Weight: Change From Beginning to End of the Extension Period(week 24, week 30, week 36, week 48)
- Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period(baseline (week -2), week 12, week 24)
- Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period(baseline (week -2), week 12, week 24)
- Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period(baseline (week -2), week 12, week 24)
- Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period(week 36, week 48)
- Daily Dose of Liraglutide(week 1, week 2, week 6, week 12, week 24)
- Daily Dose of Insulin Glargine Administered During the Extension Period(week 30, week 36, week 48)
- Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period(week 24, week 36, week 48)
- Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period(baseline (week 0), week 6, week 12, week 18, week 24)
- Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period(week 24, week 30, week 36, week 48)
- Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period(baseline (week 0), week 12, week 24)
- Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period(week 24, week 36, week 48)
- Body Weight: Change From Baseline to the End of the Comparative Period(baseline (week 0), week 2, week 6, week 12, week 18, week 24)
- Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period(all across the comparative period (from week 0 to week 24))
- Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period(all across the extension period (from week 24 to week 48))