Individually tailored treatment in type 2 diabetes

Individually tailored treatment in type 2 diabetes - Individually tailored treatment in type 2 diabetes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004883-23-DK

Enrollment

Unknown

Registered

2012-12-20

Start date

2012-12-20

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): 1) All cause death 2) Socioeconomic cost & quality of life ;Timepoint(s) of evaluation of this end point: After 10 years of follow-up	—

Countries

Denmark

Contacts

Public ContactHenning Beck-Nielsen

Henning Beck-Nielsen

henning.beck-nielsen@ouh.regionsyddanmark.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026