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
- Conditions
- Diabetes MellitusMedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-002047-92-GB
- Lead Sponsor
- ewcastle Primary Care Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 146
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary objectives will include the assessment of any between-treatment differences in single point plasma glucose levels or multi-point blood glucose profile, HbA1c, incidence of hypoglycaemia, blood glucose variability, weight change, or lipid profile.;Main Objective: The primary objective of this study is to assess whether insulin detemir, when injected once-daily at an individually appropriate time (either before breakfast or at bedtime), can provide superior blood glucose control to insulin glargine injected indiscriminantly at bedtime, in people who had clearly different dose requirements, day and night, when their insulin was previously given as a twice-daily regimen.<br><br>;Primary end point(s): The proportion of patients (responders) achieving average pre-breakfast plasma glucose < 6.5 mmol/l and pre-dinner plasma glucose < 6.5 mmol/l in the last week of study, without hypoglycaemia in the last 4 weeks of the study confirmed by a blood glucose reading of < 3.5 mmol/l.
- Secondary Outcome Measures
Name Time Method