NCT00862875已完成4 期
Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
Institut de Recherches Cliniques de Montreal1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Changes in total fat mass (in kg)
研究概览
简要总结
The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator.
- •Inadequate Glucose control: Hemoglobin A1c (HbA1c) percentage in the range of ≥ 7.5 - 12.0%
- •Stable body weight for previous 3 months (± 5 kg).
- •Structured exercise lower than 4 hours per week.
- •Metformin ≥1.5 g/day
排除标准
- •Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
- •Type 1 Diabetes Mellitus
- •Previous treatment with insulin (< 6 months prior inclusion). Insulin therapy for less than 6 days at the time of an acute event is acceptable.
- •Secondary diabetes mellitus (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young
- •Proliferative retinopathy/maculopathy requiring treatment
- •Hypoglycemia unawareness or recurrent major hypoglycaemia
- •Pregnancy and breast-feeding
- •Unstable coronary artery disease
- •Heart Failure as defined by class IV according to NYHA classification
- •Recent (< 6 months) history of myocardial infarction, stroke or T.I.A, ventricular arrhythmias, or unstable supra-ventricular arrhythmias.
- •Renal Insufficiency. Creatinine clearance < 40 ml/min (MDRD formula).
- •Acute (< 2 months) or Chronic infectious diseases requiring either hospitalization or antibiotic treatment for more than 2 weeks
- •Recent (< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer
- •Major psychiatric diseases
- •History of drug addiction
- •Previous bariatric surgery
- •Medication that affects weight such as
- •Systemic corticosteroids (prednisone)
- •Anti-obesity medication (Xenical® or Meridia®)
- •Antidepressant medication associated with significant weight impact such as Zyprexa®, Remeron® based on investigator judgment.
- •Growth hormone therapy or testosterone supplementation should be initiated for at least 6 months and at stable dose for 3 months prior to enrolment
- •Medication that affects glycemic control and hypoglycemic unawareness based on investigator judgment.
研究组 & 干预措施
1:Insulin detemir
Experimental
Insulin detemir (Levemir® - Novolin® 4 pen)
干预措施: Detemir or Glargine (Drug)
2:Insulin Glargin
Active Comparator
Insulin glargine (Lantus® - Solostar®)
干预措施: Detemir or Glargine (Drug)
结局指标
主要结局
Changes in total fat mass (in kg)
时间窗: Baseline and 6 months
次要结局
- Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.(Baseline and 6 months)
研究者
Rémi Rabasa-Lhoret
MD, PhD
Institut de Recherches Cliniques de Montreal
研究点 (1)
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