NCT00656422终止3 期
Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- To describe changes in hepatic fat content between groups.
研究概览
简要总结
The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age > 18 years and < 80 years
- •Gender: female, male
- •Type 2 diabetes
- •BMI: 20.0 - 38.0
- •Anti-GAD antibody negative
- •Fasting blood glucose > 126 mg/dl
- •HbA1c 7.0 - 11.0%
- •Need for insulin therapy
排除标准
- •Previous therapy with insulin within the last 3 months prior to inclusion into the study
- •Previous therapy with glitazones within the last 6 months prior to inclusion into the study
- •Change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed)
- •Concomitant participation in other clinical trials
- •Type 1 diabetes
- •Cardiac and macrovascular disease
- •Malignancy including leukaemia and lymphoma within the last 5 years
- •Liver disease: cirrhosis or chronic active hepatitis, except fat liver
- •Significant renal dysfunction
- •other Endocrine disease
- •significant laboratory abnormalities
- •History of active substance abuse (including an average alcohol consume of > 40g/day and drugs) within the past 2 years
- •Female patients: Pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important)
- •Present therapy with systemic steroids
- •Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
- •Use of anti-obesity drugs 3 months prior or during the trial
- •Potentially unreliable subjects, probably non compliant subjects, and those judged by the investigator to be unsuitable for the study
- •Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
- •Known hypersensitivity to insulin detemir, insulin glargine or to any of the other components
研究组 & 干预措施
insulin Levemir
Experimental
干预措施: insulin Levemir (Drug)
insulin Lantus
Experimental
干预措施: insulin Lantus (Drug)
结局指标
主要结局
To describe changes in hepatic fat content between groups.
时间窗: week 26, week 52
次要结局
- To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine.(week 26, week 52)
- To evaluate changes in body fat and visceral adipose tissue between groups.(week 26, week 52)
- To describe changes in waist and hip circumferences between groups.(weel 26, week 52)
- To describe changes in eating behavior and food selection between groups.(week 26, week 52)
- To describe changes in well being and disease perception between groups.(week 26, week 52)
- To evaluate the daily insulin dose between groups.(1 year)
- To describe the fasting blood glucose between groups.(1 year)
- To evaluate hypoglycaemia between groups.(1 year)
- To evaluate safety between groups.(1 year)
研究者
研究点 (5)
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