A multi-national, open labelled, randomised, stratified, parallel group 36 week comparison of twice daily Biphasic Insulin Aspart 30 versus thrice daily Biphasic Insulin Aspart 50 and 70 all in combination with metformin in subjects with type 2 diabetes. (INTENSIMIX-trial)

ovo Nordisk A/S0 个研究点目标入组 0 人开始时间: 2005年2月23日最近更新: 2020年10月13日

试验速览

暂无简介。

•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
•3.Currently treated with human or analogue insulin once or twice daily for at least 3 months
•4.Currently treated with metformin within the interval of 1000 - 2550 mg daily. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period
•5.Male or female age = 18 years of age
•6.HbA1c = 7.5% and =12.0% (based on HPLC/ Central lab.)
•7.Total daily insulin dose < 1.80 U/kg body weight
•8.Able and willing to perform SMPG
•9.Willing to take up to 3 insulin injections per day
•10.Willing to eat 3 main meals (breakfast, lunch and dinner) per day.
•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

•1.Known or suspected allergy to trial products or related products
•2.Previous participation in this trial (participation defined as screening)
•3.BMI < 25.0 or > 40.0 kg/m2
•4.Impaired hepatic function (alanine aminotransferase (ALAT/SGPT) or alkaline phosphatase (AP) = 2 times upper referenced limit)
•5.Impaired renal function with serum creatinine = 135 µmol/L (1.5 mg/dl)
•6.Cardiac disease, within the last 12 months, defined as:
•- decompensated heart failure (NYHA class III or IV)
•- unstable angina pectoris
•- myocardial infarction
•7.Proliferative retinopathy or macular oedema requiring acute treatment
•8.Metformin contraindications according to local practice
•9.TZD’s within 6 months prior to randomisation
•10.Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. For woman of childbearing potential adequate contraceptive measures are considered as: An intrauterine device, oral contraceptives and barrier methods. Except for Denmark and France where barrier methods are not accepted as adequate contraceptives
•11.Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
•12.Any disease or condition which the Investigator feels would interfere with the trial
•13.Receipt of any investigational drug within 1 month prior to this trial.

发起方