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.The 3L Study (Levemir in Late Life)Trial Phase: 4

Phase 1

• Conditions: Type 2 Diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2006-006589-41-FR
• Lead Sponsor: ovo Nordisk Pharmaceutique S.A.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-27
• Study Completion: 2008-12-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

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.Subject = 75 years old,
4.Subject insulin naïve optimally treated by oral antidiabetics drugs (OAD) at maximum tolerated dose for at least 3 months and not achieving therapeutic targets
5.Patients with a medical follow up for at least 3 months
6.10.5%=HbA1c = 8.0% (local dosage within the last 6 months)

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

Exclusion Criteria

1.Type 1 diabetes, secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
2.HbA1c > 10.5%
3.Previous treatment with (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator).
4.Proliferative retinopathy, maculopathy requiring treatment
5.Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
6.End stage liver disease (Prothrombin time < 40% except anticoagulant use, 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
7.Acute disease without bad prognosis (temporary exclusion)
8.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,
9.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
10.Legal incapacity or limited legal capacity,
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.Bad term vital prognosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified