NCT00506662终止4 期
The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 86
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) at Month 7
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.
详细描述
Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Insulin naive
- •Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
- •HbA1c between 8% - 10.5%
排除标准
- •Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
- •Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
- •Proliferative retinopathy, maculopathy requiring treatment,
- •Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
- •End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
- •Acute disease with poor prognosis
- •History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
- •Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator
- •Legal incapacity or limited legal capacity (patients under guardianship or curatorship)
- •Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment)
- •Participation in another clinical trial less than one month before inclusion in this trial
- •Illness requiring repeated hospitalisation
- •Known or suspected allergy to the insulin or any compositional component
- •Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
- •Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
- •Terminal illness
研究组 & 干预措施
Insulin detemir
Experimental
Individually adjusted dose of insulin detemir once daily
干预措施: insulin detemir (Drug)
Insulin NPH
Active Comparator
Individually adjusted dose of insulin NPH once daily
干预措施: insulin NPH (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) at Month 7
时间窗: week 0, month 7
次要结局
- Change in Mean Fasting Plasma Glucose (FPG) at Month 4(week 0, month 4)
- Change in Mean Pre-dinner Plasma Glucose at Month 4(week 0, month 4)
- Mean Number of Total Hypoglycaemic Episodes, Months 5-7(weeks -2-0, months 5-7)
- Change in Mean Pre-lunch Plasma Glucose at Month 7(week 0, month 7)
- Change in Mean Pre-lunch Plasma Glucose at Month 4(week 0, month 4)
- Change in Mean Fasting Plasma Glucose (FPG) at Month 7(week 0, month 7)
- Change in Body Weight at Month 4(week 0, month 4)
- Mean Number of Total Hypoglycaemic Episodes, Months 2-4(weeks -2-0, months 2-4)
- Change in Glycosylated Haemoglobin (HbA1c) at Month 4(week 0, month 4)
- Change in Mean Pre-dinner Plasma Glucose at Month 7(week 0, month 7)
- Change in Body Weight at Month 7(week 0, month 7)
- Mean Number of Total Hypoglycaemic Episodes, Month 1(weeks -2-0, month 1)
研究者
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