The Copenhagen Insulin and Metformin Therapy Trial (CIMT)

This study has been completed.
Sponsor:
Collaborators:
Hvidovre University Hospital
Hillerod Hospital, Denmark
Frederiksberg University Hospital
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Bispebjerg Hospital
Herlev Hospital
University Hospital Koge
Copenhagen Trial Unit, Center for Clinical Intervention Research
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00657943
First received: April 8, 2008
Last updated: February 2, 2014
Last verified: February 2014

April 8, 2008
February 2, 2014
April 2008
December 2012   (final data collection date for primary outcome measure)
Carotid intima media thickness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00657943 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Copenhagen Insulin and Metformin Therapy Trial
The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial

Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Atherosclerosis
  • Arteriosclerosis
  • Drug: metformin
    metformin tablets 2 g x 2
    Other Name: glucophage
  • Drug: insulin detemir
    insulin as requested
    Other Name: Levemir
  • Drug: insulin aspart + insulin aspart protamin
    insulin as requested
    Other Name: novomix
  • Drug: Insulin aspart
    insulin as requested
    Other Name: NovoRapid
  • Experimental: 1M
    Metformin + Levemir x1
    Interventions:
    • Drug: metformin
    • Drug: insulin detemir
  • Placebo Comparator: 1P
    Placebo + Levemir x1
    Intervention: Drug: insulin detemir
  • Experimental: 2M
    metformin + NovoMix
    Interventions:
    • Drug: metformin
    • Drug: insulin aspart + insulin aspart protamin
  • Placebo Comparator: 2P
    Placebo + NovoMix
    Intervention: Drug: insulin aspart + insulin aspart protamin
  • Experimental: 3M
    Metformin + 4x therapy
    Interventions:
    • Drug: metformin
    • Drug: insulin detemir
    • Drug: Insulin aspart
  • Placebo Comparator: 3P
    Placebo + 4x therapy
    Interventions:
    • Drug: insulin detemir
    • Drug: Insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females over 30 years of age
  • Type 2 diabetes
  • Body mass index (BMI): 25.0-39.9 kg/m2
  • HbA1c above 7.5 %
  • Antidiabetic tablet-treatment during 1 year minimum AND / OR
  • Insulin treatment during a minimum of 3 months
  • Negative pregnancy test
  • Signed, informed consent

Exclusion Criteria:

  • MI, coronary revascularization, TCI,or apoplexy within the last 3 months
  • TCI with verified stenosis of above 70%
  • Heart failure (NYHA class III or IV)
  • Former cancer patient, unless disease-free period of more than 5 years
  • estimated creatinine clearance < 60 ml/min Liver disease
  • Alcohol abuse
  • Drug abuse
  • Retinopathy with on-going laser treatment at start of study
  • Other acute or chronic serious disease leading to hypoxia
  • Pregnant or breastfeeding women
  • Women of child-bearing potential, not using contraceptives
  • Allergy to medication used in the study
  • Incapable of understanding the nature of the informed consent
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00657943
EudraCT 2007-006665-33
Yes
Lise Tarnow, Steno Diabetes Center
Steno Diabetes Center
  • Hvidovre University Hospital
  • Hillerod Hospital, Denmark
  • Frederiksberg University Hospital
  • University Hospital, Gentofte, Copenhagen
  • Rigshospitalet, Denmark
  • Bispebjerg Hospital
  • Herlev Hospital
  • University Hospital Koge
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Novo Nordisk A/S
Principal Investigator: Thomas Almdal, MD DMSc Hvidovre University Hospital
Steno Diabetes Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP