NCT01541215已完成3 期
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population
排除标准
- •Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics
研究组 & 干预措施
Lira + Met
Experimental
干预措施: liraglutide (Drug)
Lira + Met
Experimental
干预措施: metformin (Drug)
Placebo + Met
Placebo Comparator
干预措施: placebo (Drug)
Placebo + Met
Placebo Comparator
干预措施: metformin (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, week 26
Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
次要结局
- Change From Baseline in 7-point Self-measured Plasma Glucose(Week 0, week 52)
- Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)(Week 0, week 52)
- Ratio to Baseline: HOMA-B(Week 0, week 52)
- Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)(Week 0, week 26)
- Ratio to Baseline: HOMA-IR(Week 0, week 52)
- Ratio to Baseline: Total Cholesterol(Week 0, week 52)
- Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol(Week 0, week 26)
- Ratio to Baseline: LDL Cholesterol(Week 0, week 52)
- Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol(Week 0, week 26)
- Ratio to Baseline: VLDL Cholesterol(Week 0, week 52)
- Change in Bone Age Assessment (X-ray of Left Hand and Wrist)(Week 0, week 52)
- Pubertal Assessment/Progression (Tanner Staging)(Week 0, week 26, week 52)
- Growth (Height Velocity)(Week 0, week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
- Number of Subjects Having HbA1c Below 7.0%(Week 52)
- Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes(Week 52)
- Number of Subjects Having HbA1c Below 7.5%(Week 52)
- Change in HbA1c(Week 0, week 52)
- Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)(Week 0, week 26)
- Number of Subjects Having HbA1c Maximum 6.5%(Week 52)
- Change in FPG(Week 0, week 52)
- Change From Baseline in Body Weight(Week 0, week 52)
- Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104(Week 52, week 104)
- Change in Mean 7-point Self-measured Plasma Glucose(Week 0, week 26)
- Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol(Week 0, week 26)
- Ratio to Baseline: HDL Cholesterol(Week 0, week 52)
- Ratio to Baseline: Triglycerides(Week 0, week 52)
- Ratio to Baseline: Free Fatty Acids(Week 0, week 52)
- Change From Baseline in Pulse(Week 0, week 52)
- Change From Baseline in Height SDS(Week 0, week 52)
- Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)(Week 0, week 52)
- Change From Baseline in BMI Standard Deviation Score (SDS)(Week 0, week 52)
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure)(Week 0, week 52)
- Ratio to Baseline: Fasting Insulin(Week 0, week 52)
- Ratio to Baseline: Fasting Pro-insulin(Week 0, week 52)
- Ratio to Baseline: Pro-insulin/Insulin Ratio(Week 0, week 52)
- Ratio to Baseline: Fasting Glucagon(Week 0, week 52)
- Ratio to Baseline: Fasting C-peptide(Week 0, week 52)
- Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)(Week 0, week 26)
- Height Velocity SDS(Week 0, week 52)
- Number of Hypoglycaemic Episodes(0-52 weeks)
- Number of Adverse Events (Week 0-26)(0-26 weeks)
- Number of Adverse Events (Week 0-52)(0-52 weeks)
- Number of Serious Adverse Events (Week 0-26)(0-26 weeks)
- Number of Serious Adverse Events (Week 0-52)(0-52 weeks)
- Number of Adverse Events (Week 53-104)(Week 53-104)
- Number of Serious Adverse Events (Week 53-104)(Weeks 53-104)
- Growth (Height Velocity)- Week 104(Week 0, week 104)
- Height Velocity SDS- Week 104(Week 0, week 104)
- Change From Week 52 in Height SDS- Week 104(Week 52, week 104)
- Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104(Week 52, week 104)
- Number of Adverse Events (Week 53-156)(Week 53-156)
- Number of Serious Adverse Events (Week 53-156)(Weeks 53-156)
- Growth (Height Velocity)- Week 156(Week 0, week 156)
- Height Velocity SDS- Week 156(Week 0, week 156)
- Change From Week 52 in Height SDS- Week 156(Week 52, week 156)
- Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156(Week 52, week 156)
- Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156(Week 52, week 156)
研究者
研究点 (1)
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