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The Copenhagen Insulin and Metformin Therapy Trial (CIMT)

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: NCT00657943
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : February 4, 2014
Information provided by (Responsible Party):

April 8, 2008
April 14, 2008
February 4, 2014
April 2008
December 2012   (Final data collection date for primary outcome measure)
Carotid intima media thickness [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT00657943 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: 18 months ]
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
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, 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
    • Drug: metformin
    • Drug: insulin detemir
  • Placebo Comparator: 1P
    Placebo + Levemir x1
    Intervention: Drug: insulin detemir
  • Experimental: 2M
    metformin + NovoMix
    • 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
    • Drug: metformin
    • Drug: insulin detemir
    • Drug: Insulin aspart
  • Placebo Comparator: 3P
    Placebo + 4x therapy
    • Drug: insulin detemir
    • Drug: Insulin aspart

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
EudraCT 2007-006665-33
Not Provided
Not Provided
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