NCT02015130

Brief Summary

The prevalence of Type 2 diabetes (T2D) is rising rapidly worldwide. In Denmark approximately 8% of adults have T2D and more than 25.000 are diagnosed each year. This has vast consequences for society and the patient. Standardized treatment aiming at normalizing blood glucose and hypertension comparable to healthy individuals, have been tested in large studies. The effect on cardiovascular disease and other complications have been modest at best and one study showed an increased mortality with intensive treatment. The standardized treatment often results in polypharmacy, which increases the risk of patients discontinuing treatment. We propose a new approach to treatment of T2D, where the patients' individual characteristics are considered. The aetiology of the diabetes can be different, which warrants different treatment. Many patients have concomitant illness which can affect the way the patient is treated. A tight regulation of blood glucose can in some patient constitute a risk of adverse effects, especially hypoglycemia. In that sense individual targets for the treatment are important. Effective lifestyle treatment has importance for a successful outcome and we therefore offer an application that can help the patient and the physician organizing activity individually. The objective of individual treatment is to choose the most effective medication. If a prescribed drug does not have the desired effect it should be replaced with a different drug. The overall goal is to reduce the number of substances and side-effects, but simultaneous improve treatment and reduce the incidence of cardiovascular and other diabetes-related complications. This will in turn result in improved quality of life and improved adherence to treatment. The potential effect of individual tailored treatment of T2D is to improve the guidelines of treatment, not only to improve the patients' health, but also to reduce the socioeconomic consequences of the growing T2D prevalence

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,246

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

12 years

First QC Date

December 3, 2013

Last Update Submit

September 18, 2017

Conditions

Type 2 DiabetesHypertension

Keywords

Type 2 diabeteshypertensionindividual

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint: 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 cancer

    10 year

Secondary Outcomes (3)

  • All cause mortality

    10 years

  • Socioeconomic cost

    10 years

  • Quality of life

    10 years

Other Outcomes (14)

  • Myocardial infarction, non-fatal

    10 years

  • Death from myocardial infarction

    10 years

  • Coronary revascularisation, CABG or PCI

    10 years

  • +11 more other outcomes

Study Arms (2)

individual treatment

EXPERIMENTAL

Individualized treatment

Other: Individual treatment

control group

NO INTERVENTION

treatment according to current national guidelines

Interventions

Individual treatmentOTHER

See detailed description

Also known as: mulitinterventional
individual treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly discovered diabetes patients clinically classified as T2D patients of both sex'
  • Participation in the DD2 cohort
  • Signed informed consent

You may not qualify if:

  • Patients with age under 18
  • Type 1 diabetes. If patients at baseline investigations have age\<30 years AND C-peptid\<300pmol/l AND GAD-ab titer\> 20 IU/ml they are also considered as having type 1 diabetes.
  • Life expectancy below 2 years
  • Psychiatric or mental disease that affects the patients ability to give informed consent or participate adequately in the study
  • Ongoing abuse of alcohol or illicit drugs that affects the patients ability to give informed consent or participate adequately in the study
  • Participation in any other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital of south west Denmark

Esbjerg, 6700, Denmark

Location

Medicinsk afdeling.Holbæk Sygehus.

Holbæk, 4300, Denmark

Location

Næstved Lægecenter

Næstved, 4700, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (3)

  • Norlen T, Olesen TB, Domazet SL, Nielsen JS, Brond JC, Olsen MH, Hojlund K, Stidsen JV. Physical activity and albuminuria in individuals recently diagnosed with type 2 diabetes. J Diabetes Complications. 2025 Aug;39(8):109065. doi: 10.1016/j.jdiacomp.2025.109065. Epub 2025 May 13.

    PMID: 40398345DERIVED

  • Domazet SL, Tarp J, Thomsen RW, Hojlund K, Stidsen JV, Brond JC, Grontved A, Nielsen JS. Accelerometer-derived physical activity and sedentary behaviors in individuals with newly diagnosed type 2 diabetes: A cross-sectional study from the Danish nationwide DD2 cohort. Front Sports Act Living. 2023 Jan 25;4:1089579. doi: 10.3389/fspor.2022.1089579. eCollection 2022.

    PMID: 36761371DERIVED

  • Stidsen JV, Nielsen JS, Henriksen JE, Friborg SG, Thomsen RW, Olesen TB, Olsen MH, Beck-Nielsen H. Protocol for the specialist supervised individualised multifactorial treatment of new clinically diagnosed type 2 diabetes in general practice (IDA): a prospective controlled multicentre open-label intervention study. BMJ Open. 2017 Dec 10;7(12):e017493. doi: 10.1136/bmjopen-2017-017493.

    PMID: 29229652DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • jacob Stidsen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Henning Beck-Nielsen, Dr.med, MD

    Odense University Hospital

    STUDY CHAIR

  • Jeppe Gram, MD, Phd

    Esbjerg Hospital - University Hospital of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Jan Erik Henriksen, MD, Phd

    Odense University Hospital

    STUDY CHAIR

  • Jens Nielsen, PhD

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 19, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

DK(4)