NCT00696657已完成2 期
Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.
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
- •Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
- •Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
- •HbA1c: 7.0-10.0 % (both inclusive)
- •Body weight between 60 kg and 110 kg
排除标准
- •Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
- •Impaired liver or kidney function
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
- •Recurrent major hypoglycaemia or hypoglycaemic unawareness
- •Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
研究组 & 干预措施
G1
Placebo Comparator
干预措施: placebo (Drug)
A
Experimental
干预措施: semaglutide (Drug)
B
Experimental
干预措施: semaglutide (Drug)
C
Experimental
干预措施: semaglutide (Drug)
D
Experimental
干预措施: semaglutide (Drug)
E
Experimental
干预措施: semaglutide (Drug)
F
Experimental
干预措施: semaglutide (Drug)
G2
Placebo Comparator
干预措施: placebo (Drug)
G3
Placebo Comparator
干预措施: placebo (Drug)
G4
Placebo Comparator
干预措施: placebo (Drug)
G5
Placebo Comparator
干预措施: placebo (Drug)
G6
Placebo Comparator
干预措施: placebo (Drug)
H
Experimental
干预措施: liraglutide (Drug)
I
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
HbA1c
时间窗: After 12 weeks of treatment.
Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.
次要结局
- Change From Baseline in ECG(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)(Week 0, week 12)
- Percentage of Subjects With an Adverse Events(After 12 weeks of treatment.)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)(Week 0, week 12.)
- Change From Baseline in Vital Signs (Pulse)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)(Week 0, week 12.)
- Percentage of Subjects With Hypoglycaemic Episode(After 12 weeks of treatment)
- Change From Baseline in Vital Signs (Blood Pressure; SBP)(Week 0, week 12)
- Change From Baseline in Vital Signs (Blood Pressure; DBP)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)(Week 0, week 12)
- Change From Baseline in Calcitonin(Week 0, week 12.)
- Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)(Week 0, week 12)
- Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)(Week 0, week 12)
- Percentage of Subjects Developing Anti-semaglutide Antibodies(After 12 weeks of treatment)
- Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)(Week 0, week 12)
研究者
研究点 (1)
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