Individually tailored treatment in type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-004883-23-DK
• Lead Sponsor: Henning Beck-Nielsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-20
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Newly discovered T2D patients of both sex`
2)Participation in the DD2 cohort
3)Signed informed consent

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 1696
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

Exclusion Criteria

1)Patients with age under 18
2)Type 1 diabetes
3)Life expectancy below 2 years
4)Psychiatric or mental disease
5)Ongoing abuse of alcohol or illicit drugs
6)Participation in any other clinical trial
7)Pregnancy at time of inclusion or planned future pregnancy (A negative pregnancy test is mandatory before inclusion. In women who are sterile, infertile or is postmenopausal (12 month without menstruation) this test is omitted.)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of individually tailored treatment compared to contemporary treat-to-target” approach on the incidence of a composite endpoint consisting of micro- and macrovascular events, cancer, severe hypoglycaemic events and over-all death over a 10 year period.;Secondary Objective: Secondary objectives is to show that individualised treatment reduce the number of pharmacological agents used, reduce the number of side effects, improve quality of life and is cost efficient. ;Primary end point(s): The primary endpoint will be a composite endpoint of all cause mortality, non-fatal myocardial infarction, coronary revascularization, cardiac arrest with resuscitation, heart failure, non-fatal stroke, progression of nephropathy or retinopathy, severe hypoglycaemia and development of cancer.;Timepoint(s) of evaluation of this end point: After a mean follow-up of 10 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1)All cause death<br>2)Socioeconomic cost & quality of life<br>;Timepoint(s) of evaluation of this end point: After 10 years of follow-up