We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Individually Tailored Treatment of Type 2 Diabetes (ITT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02015130
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2013
Last Update Posted : September 19, 2017
Region of Southern Denmark
Hospital of South West Denmark
General Practice Research Database
Information provided by (Responsible Party):
Jacob Volmer Stidsen, Odense University Hospital

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

Condition or disease Intervention/treatment
Type 2 Diabetes Hypertension Other: Individual treatment

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2246 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individually Tailored Treatment of Type 2 Diabetes
Study Start Date : October 2013
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: individual treatment
Individualized treatment
Other: Individual treatment
See detailed description
Other Name: mulitinterventional
No Intervention: control group
treatment according to current national guidelines

Primary Outcome Measures :
  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 [ Time Frame: 10 year ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 10 years ]
  2. Socioeconomic cost [ Time Frame: 10 years ]
  3. Quality of life [ Time Frame: 10 years ]

Other Outcome Measures:
  1. Myocardial infarction, non-fatal [ Time Frame: 10 years ]
  2. Death from myocardial infarction [ Time Frame: 10 years ]
  3. Coronary revascularisation, CABG or PCI [ Time Frame: 10 years ]
  4. Heart failure: New, hospital admission due to acute deterioration (not related to new MI) or chronic regression in NYHA class [ Time Frame: 10 years ]
  5. Stroke or TCI, non-fatal [ Time Frame: 10 years ]
  6. Death from stroke [ Time Frame: 10 years ]
  7. Other revascularisation procedures [ Time Frame: 10 years ]
  8. Amputation due to macrovascular insufficiency [ Time Frame: 10 years ]
  9. Cardiac arrest with resuscitation [ Time Frame: 10 years ]
  10. Renal failure (defined by the need for chronic dialysis), development of macroalbuminuria, doubling of creatinine (only above 200) [ Time Frame: 10 years ]
  11. Proliferative retinopathy or macular oedema that require laser therapy, vitrectomy, diabetes related blindness (snellen visual acuity below 0.1) [ Time Frame: 10 years ]
  12. Severe hypoglycaemic events [ Time Frame: 10 years ]
  13. All-cause malignant cancer (not basocellular carcinoma) [ Time Frame: 10 years ]
  14. All cause hospitalization [ Time Frame: 10 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Newly discovered diabetes patients clinically classified as T2D patients of both sex`
  2. Participation in the DD2 cohort
  3. Signed informed consent

Exclusion Criteria:

  1. Patients with age under 18
  2. 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.
  3. Life expectancy below 2 years
  4. Psychiatric or mental disease that affects the patients ability to give informed consent or participate adequately in the study
  5. Ongoing abuse of alcohol or illicit drugs that affects the patients ability to give informed consent or participate adequately in the study
  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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015130

Hospital of south west Denmark
Esbjerg, Denmark, 6700
Medicinsk afdeling.Holbæk Sygehus.
Holbæk, Denmark, 4300
Næstved Lægecenter
Næstved, Denmark, 4700
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Region of Southern Denmark
Hospital of South West Denmark
General Practice Research Database
Principal Investigator: jacob Stidsen, MD Odense University Hospital
Study Chair: Henning Beck-Nielsen, Dr.med, MD Odense University Hospital
Principal Investigator: Jeppe Gram, MD, Phd Hospital of South West Denmark
Study Chair: Jan Erik Henriksen, MD, Phd Odense University Hospital
Study Chair: Jens Nielsen, PhD Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacob Volmer Stidsen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02015130     History of Changes
Other Study ID Numbers: Eudract2012-004883-23
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jacob Volmer Stidsen, Odense University Hospital:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases