Effect of NPH insulin, insulin detemir and insulin glargine on IGFBP-1 production and serum IGF-I in subjects with type 1 diabetes: An open-label, randomised, triple cross-over trial

niversity of Aarhus0 个研究点开始时间: 2012年1月16日最近更新: 2012年3月20日

研究概览

暂无简介。

•1.Informed consent obtained before any trial-related activities.
•2.Diagnosis of diabetes mellitus according to WHO criteria; history and clinical course consistent with type 1 diabetes.
•3.Diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (CSII) at least 6 months at time of inclusion.
•4.Total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
•5.HbA1c between 6% and 9% (both values included).
•6.Age = 18 years.
•7.BMI between 18.5 and 28 kg /m2 (including both values).
•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 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Known or suspected allergy to trial product(s) or related products.
•2.Recurrent major hypoglycaemic episodes.
•3.Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
•4.Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
•5.Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
•6.Kidneys: Impaired renal function corresponding to serum-creatinin > 150 µmol/l according to the local laboratory.
•7.Any disease judged by the investigator to affect the trial.
•8.Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures – adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

发起方

niversity of Aarhus