A trial comparing efficacy and safety of NN5401 withinsulin glargine, both in combination with oralantidiabetic drugs in subjects with type 2 diabetes

ovo Nordisk A/S0 个研究点目标入组 0 人开始时间: 2009年8月6日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Informed consent obtained before any trial-related activities. (Trial related activities are defined as any procedures that would not have been performed during standard management of the subject).
•Male or female = 18 years of age
•Type 2 diabetes mellitus (diagnosed clinically) for = 6 months
•Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn [NPH] insulin) OD, for at least 3 months
•Ongoing treatment with: metformin with or without other OADs for at least 3 months prior to randomisation
•HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
•BMI = 40.0 kg/m²
•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

•Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
•Total daily insulin dose above 1 U/kg
•Treatment with glucagon-like peptide 1(GLP-1) receptor agonists within 3 months prior to visit 1
•Current rosiglitazone users
•Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
•Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke;
•decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

发起方