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Individually Tailored Treatment of Type 2 Diabetes (ITT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Odense University Hospital
Sponsor:
Collaborators:
Region Southern Denmark
Hospital of South West Denmark
General Practice Research Database
Information provided by (Responsible Party):
Jacob Volmer Stidsen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02015130
First received: December 3, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Type 2 Diabetes
Hypertension
Other: Individual treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individually Tailored Treatment of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Socioeconomic cost [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Myocardial infarction, non-fatal [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Death from myocardial infarction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Coronary revascularisation, CABG or PCI [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Heart failure: New, hospital admission due to acute deterioration (not related to new MI) or chronic regression in NYHA class [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Stroke or TCI, non-fatal [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Death from stroke [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Other revascularisation procedures [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Amputation due to macrovascular insufficiency [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Cardiac arrest with resuscitation [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Renal failure (defined by the need for chronic dialysis), development of macroalbuminuria, doubling of creatinine (only above 200) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Proliferative retinopathy or macular oedema that require laser therapy, vitrectomy, diabetes related blindness (snellen visual acuity below 0.1) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Severe hypoglycaemic events [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • All-cause malignant cancer (not basocellular carcinoma) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • All cause hospitalization [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2246
Study Start Date: October 2013
Estimated Study Completion Date: October 2025
Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: individual treatment
Individualized treatment
Other: Individual treatment
See detailed description
Other Name: mulitinterventional
No Intervention: control group
treatment according to current guidelines

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015130

Contacts
Contact: Jacob Stidsen, MD 0045 26582040 jacob.volmer.stidsen@rsyd.dk

Locations
Denmark
Hospital of south west Denmark Not yet recruiting
Esbjerg, Denmark, 6700
Sub-Investigator: Monija Mrgan, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Principal Investigator: jacob Stidsen, MD         
Sponsors and Collaborators
Odense University Hospital
Region Southern Denmark
Hospital of South West Denmark
General Practice Research Database
Investigators
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
  More Information

No publications provided

Responsible Party: Jacob Volmer Stidsen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02015130     History of Changes
Other Study ID Numbers: Eudract2012-004883-23
Study First Received: December 3, 2013
Last Updated: December 12, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Type 2 diabetes
hypertension
individual

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

ClinicalTrials.gov processed this record on November 20, 2014