EUCTR2006-003269-15-SE进行中（未招募）不适用
Impact of exercise training and insulin treatment in patients with type 2 diabetes treated with metformin
Karolinska University hospital0 个研究点开始时间: 2006年7月11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
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
- •1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •2.Type 2 diabetes according to clinical judgment.
- •3.Duration of type 2 diabetes = 12 months since diagnosis.
- •4.C-peptide ?0.4 nmol/L
- •5.Insulin naïve. Short term insulin treatment (7 days or less within the last 6 months) is allowed.
- •6.Oral anti-diabetic treatment for at least 4 months.
- •7.Age ? 35 and ?65 years, female or male.
- •8.BMI ? 35 kg/m2.
- •9.HbA1c =7.0% at screening and based on analysis from the central laboratory are eligible for the study.
- •10.Able and willing to adhere to the trial-specific insulin/OAD/exercise regimen for the entire trial period.
- •11.Able and willing to perform self-monitoring of blood glucose according to the protocol.
- •12.Able and willing to perform tests and examinations specified in the protocol.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous participation in this trial. Participation is defined as randomisation.
- •2.Receipt of any investigational drug within 4 weeks prior to this trial.
- •3.Anticipated change in dose of concomitant medication which may interfere with glucose metabolism, such as systemic corticosteroids, non-selective beta-blockers, mono amine oxidase (MAO) inhibitors and anabolic steroids.
- •4.Proliferative retinopathy or maculopathy that requires acute treatment or has had laser treatment within the last 6 months.
- •5.Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator.
- •6.Impaired hepatic function measured as alanine aminotransferase (ALAT) ? three times the upper reference limit based on analysis from the central laboratory.
- •7.Impaired renal function measured as S-creatinine ?130 µmil/L
- •8. Cardiac disease defined as :
- •a.Unstable angina pectoris
- •b.Myocardial infarction (MI) within the last 6 months
- •c.Congestive heart failure NYHA class III and IV
- •9.Uncontrolled treated/untreated hypertension (systolic blood pressure ?180 mmHg and/or diastolic blood pressure ? 105mmHg).
- •10.Chronic foot ulcer.
- •11.Proliferative retinopathy.
- •12.Physical limitations which do not allow the patient to participate in an exercise training program.
- •13.Uncontrolled thyroid disorder.
- •14.Known or suspected allergy to trial product or related products.
- •15.Malignancy.
- •16.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
- •17.Any other condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results.
- •18.GAD positive.
- •19.Tiazolidindione therapy within 6 months prior to trial.
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