Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 846
- 试验地点
- 1
- 主要终点
- Change (%) From Baseline in Body Weight (Fasting)
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds
- •HbA1c 7.0-10.0% (both inclusive)
- •Body Mass Index (BMI) at least 27.0 kg/m^2
- •Stable body weight
- •Preceding failed dietary effort
排除标准
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
- •Known proliferative retinopathy or maculopathy
- •History of acute or chronic pancreatitis
- •Obesity induced by drug treatment
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive disorder or suicide attempt
- •Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- •Screening calcitonin of 50 ng/L or above
- •Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
研究组 & 干预措施
Lira 3.0 mg
干预措施: liraglutide (Drug)
Lira 1.8 mg
干预措施: liraglutide (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change (%) From Baseline in Body Weight (Fasting)
时间窗: Week 0, week 56
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Proportion of Subjects Losing at Least 5% of Baseline Body Weight
时间窗: at 56 weeks
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Proportion of Subjects Losing More Than 10% of Baseline Body Weight
时间窗: at 56 weeks
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
次要结局
- Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)(Week 0, week 56)
- Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%(at 56 weeks)
- Incidence of Hypoglycaemic Episodes(Weeks 0-56)
- Proportion of Subjects Reaching Target HbA1c Below 7%(at 56 weeks)
- Change From Baseline in Waist Circumference(Week 0, week 68)
- Change (%) From Baseline in Body Weight (Fasting)(Week 0, week 68)
- Change (%) From Week 56 to 68 in Body Weight (Fasting)(Week 56, week 68)
- Change From Week 56 to 68 in Waist Circumference(Week 56, week 68)