evemir® in ageing patients with type 2 diabetesA seven-month open-labelled randomised multi-centre two-group parallel trial comparing administration of insulin detemir once daily in the morning versus NPH insulin once daily in the morning in ageing subjects with type 2 diabetes.Trial Phase: 4 - The 3L Study (Levemir in Later Life)
- Conditions
- Type 2 DiabetesMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-006589-41-GB
- Lead Sponsor
- ovo Nordisk Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 286
1.Informed Consent must be 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.Subject = 70 years old,
4.Subject insulin naïve and optimally treated by oral antidiabetics drugs (OAD) at maximum tolerated dose for at least 3 months and not achieving therapeutic targets
5.8.0% = HbA1c = 10.5% (local dosage within the last 6 months)
6.Able to comply with the requirements of the trial.
Moreover, the metabolic control appropriate for the patients to be included should target an HbA1c between 7.0% and 8.0%.
Concomitant treatment: in case of previous metformin treatment, metformin will be continued at optimal dose, providing renal clearance assessed by MDRD > 60 ml/mn and no renal impairment occurs throughout the study. Thiazolidinediones must be discontinued at least 2 weeks before randomisation. Sulfonylureas and alpha-glucosidase inhibitors must be discontinued at randomisation.
Elderly patients living in specific medical institutions are authorized to take part in the study, as judged by the Investigator, if they are able to give their informed consent, to understand and comply with the study procedures and if there is a benefit for the subject in taking part in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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.Secondary diabetes, MODY (Maturity Onset Diabetes of the Young),
2.Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator),
3.Proliferative retinopathy, maculopathy requiring treatment,
4.Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia,
5.End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD < 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months,
6.Acute disease withpoor prognosis,
7.History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol,
8.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE in the last six months) and any conditions as judged by the investigator,
9.Legal incapacity or limited legal capacity (patients under guardianship or curatorship),
10.Concomitant medication for Alzheimer's treatment (Memantine, Anticholinesterasique treatment),
11.Participation in another clinical trial less than one month before inclusion in this trial,
12.Illness requiring repeated hospitalisation,
13.Known or suspected allergy to the insulin or any compositional component,
14.Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
15.Any other condition that the Investigator feels would interfere with trial participation or evaluation of results,
16.Terminal illness
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method