A multicentre, open-label, randomized comparison of once daily insulin detemir given pre-breakfast or bedtime, according to need, with bedtime insulin glargine in people with type 2 diabetes characterized by an asymmetric insulin requirement between the day and night. - Birdsong

ewcastle Primary Care Trust0 个研究点目标入组 146 人开始时间: 2007年1月5日最近更新: 2020年7月27日

适应症

试验速览

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•Patient criteria to be eligible for this study will consist of the following:
•Males and females aged =18 years, diagnosed with type 2 diabetes, who are willing to give informed consent
•Patients currently receiving treatment with two insulin injections daily (morning and evening) of either NPH, or a fixed ratio human insulin or insulin analogue premix (such as 30% soluble / 70% protaminated), with or without concomitant use of oral glucose-lowering medication (OGLDs), which will be left unchanged during the trial.
•Insulin treatment as described above to have been taken for a duration of at least 2 months
•Patients able and willing to perform self-monitoring of plasma glucose
•Patients will be screened for the following inclusion criteria:
•A ratio of morning insulin dose:evening insulin dose >1.3:1 (peripheral insulin resistance substudy) or
•A ratio of evening insulin dose:morning insulin dose >1.3:1 (hepatic glucose output substudy).
•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

•Patients to be excluded from this study will include:
•Patients with HbA1c >9.0 or <6.5 % at entry visit
•Patients with body mass index >40.0 kg/m2 at entry visit
•Patients who are pregnant or for whom pregnancy during the trial is a possibility
•Patients currently receiving treatment with thiazolidinediones or meglitinide derivatives, that cannot be stopped for the duration of the trial
•Patients with high insulin dose requirements >100 U/day at entry visit
•Patients on mixed insulin regimens, such as NPH insulin and a premixed insulin, or different ratios of premixed insulin morning and evening
•Patients with known or suspected allergy to trial products or related products
•Any condition that the local investigator feels would interfere with trial participation or the evaluation of results

发起方

ewcastle Primary Care Trust