A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Initiating Insulin Therapy With Insulin Detemir in Combination With Metformin (Levemir DIET)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 611
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight
研究概览
简要总结
This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start
- •Insulin naive subjects
- •HbA1c: 7.0-9.0 % (both inclusive)
- •Body Mass Index (BMI): 25.0-45.0 kg/m^2 (both inclusive)
排除标准
- •Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor agonists within the last 3 months prior to trial enrollment
- •Cardiovascular disease within the last 6 months
- •Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment
- •Cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer)
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
研究组 & 干预措施
Control
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
干预措施: Insulin detemir (Drug)
Dietician
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
干预措施: Insulin detemir (Drug)
Dietician
Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
干预措施: Dietary regimen (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Body Weight
时间窗: Week 0, Week 26
Estimated mean change from baseline in body weight after 26 weeks of treatment.
次要结局
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)(Week 0, Week 26)
- Change From Baseline in Body Mass Index (BMI)(Week 0, Week 26)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, Week 26)
- Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes(Week 0 to Week 26)
- Rate of Treatment Emergent Adverse Events (TEAEs)(Week 0 to Week 26)
- Rate of All Treatment Emergent Hypoglycaemic Episodes(Week 0 to Week 26)