The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 9
- 主要终点
- Carotid intima media thickness
研究概览
简要总结
Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females over 30 years of age
- •Type 2 diabetes
- •Body mass index (BMI): 25.0-39.9 kg/m2
- •HbA1c above 7.5 %
- •Antidiabetic tablet-treatment during 1 year minimum AND / OR
- •Insulin treatment during a minimum of 3 months
- •Negative pregnancy test
- •Signed, informed consent
排除标准
- •MI, coronary revascularization, TCI,or apoplexy within the last 3 months
- •TCI with verified stenosis of above 70%
- •Heart failure (NYHA class III or IV)
- •Former cancer patient, unless disease-free period of more than 5 years
- •estimated creatinine clearance < 60 ml/min Liver disease
- •Alcohol abuse
- •Drug abuse
- •Retinopathy with on-going laser treatment at start of study
- •Other acute or chronic serious disease leading to hypoxia
- •Pregnant or breastfeeding women
- •Women of child-bearing potential, not using contraceptives
- •Allergy to medication used in the study
- •Incapable of understanding the nature of the informed consent
研究组 & 干预措施
1M
Metformin + Levemir x1
干预措施: metformin (Drug)
1M
Metformin + Levemir x1
干预措施: insulin detemir (Drug)
1P
Placebo + Levemir x1
干预措施: insulin detemir (Drug)
2M
metformin + NovoMix
干预措施: metformin (Drug)
2M
metformin + NovoMix
干预措施: insulin aspart + insulin aspart protamin (Drug)
2P
Placebo + NovoMix
干预措施: insulin aspart + insulin aspart protamin (Drug)
3M
Metformin + 4x therapy
干预措施: metformin (Drug)
3M
Metformin + 4x therapy
干预措施: insulin detemir (Drug)
3M
Metformin + 4x therapy
干预措施: Insulin aspart (Drug)
3P
Placebo + 4x therapy
干预措施: insulin detemir (Drug)
3P
Placebo + 4x therapy
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Carotid intima media thickness
时间窗: 18 months
次要结局
- adverse events(18 months)
研究者
Lise Tarnow
professor
Steno Diabetes Center Copenhagen