EUCTR2007-000353-65-DE进行中（未招募）不适用
Weight gain, eating patterns and development of body composition during initiation of basal insulin therapy: a comparison of insulin determir and insulin glargine
niversity Hospital Tübingen0 个研究点目标入组 160 人开始时间: 2008年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age > 18 years and < 80 years
- •- Gender: female, male
- •- Type 2 diabetes
- •- BMI: 20.0 – 38.0 (higher, if MRI is possible)
- •- Anti-GAD antibody negative
- •- Fasting blood glucose > 126 mg/dl
- •- HbA1c 7.0 – 11.0%
- •- Previous therapy with metformin or sulfonylurea or glinide or a combination of metformin with sulfonyurea or metformin with glinide.
- •- Minimal dose per day: 3.5mg Glibenclamid, 3mg Glimepirid, at least 1500mg Metformin, 3mg Repaglinid, 300mg Nateglinid, 60mg Gliclazid MR
- •- Stable oral therapy for at least 3 months
- •- Female patients must have a negative urine pregnancy test prior to study entry and must be either at least two years postmenopausal or using one of the following means of birth control: surgical sterility, double barrier methods, intraunterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods. It is assumed that contraception for male patients is not considered as medically important.
- •- Signed written informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous therapy with insulin 3 months prior to inclusion into the study
- •- Previous therapy with glitazones 6 months prior to inclusion into the study
- •- Changesin therapy with lipid-lowering or anti-hypertensive agents within one month prior to inclusion into the study (a stable lipid-lowering or anti-hyperensive therapy is allowed )
- •- Concomitant participation in other clinical trials
- •- Type 1 diabetes
- •- Cardiovascular disease :
- •o Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs.
- •o Percutaneous coronary intervention within the past 6 months.
- •o Any of the following within the past 6 months:
- •myocardial infarction (MI) (If the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the subject can enter the study at the discretion of the investigator);
- •coronary artery bypass surgery;
- •unstable angina;
- •o Congestive heart failure NYHA class III or IV
- •- Malignancy including leukemia and lymphoma within the last 5 years
- •- Liver disease such as cirrhosis or chronic active hepatitis
- •- Significant renal dysfunction (see also exclusion criteria laboratory abnormalities)
- •- Endocrine disease:
- •o Acromegaly or treatment with growth hormone or similar drugs.
- •o Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks
- •o Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal limits
- •- Any of the following significant laboratory abnormalities:
- •o Serum creatinine levels = 2.5 mg/dl (220 ?mol/l)
- •o Fasting triglycerides ?700 mg/dl (>7.9 mmol/l)
- •- History of active substance abuse (including alcohol > 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, and those judged by the investigator to be unsuitable for the study
- •- Persons who are not familiar with the insulin injection system
- •- Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
- •- Missing signed written informed consent to participate in the study
- •- Known hypersensitivity to insuline detemir, insulin glargine or to any of the other components (see SPC/”Fachinformation appendix 17.2. and 17.3.)
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