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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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Atherosclerosis Arteriosclerosis Drug: metformin Drug: insulin detemir Drug: insulin aspart + insulin aspart protamin Drug: Insulin aspart Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1M
Metformin + Levemir x1
Drug: metformin
metformin tablets 2 g x 2
Other Name: glucophage
Drug: insulin detemir
insulin as requested
Other Name: Levemir
Placebo Comparator: 1P
Placebo + Levemir x1
Drug: insulin detemir
insulin as requested
Other Name: Levemir
Experimental: 2M
metformin + NovoMix
Drug: metformin
metformin tablets 2 g x 2
Other Name: glucophage
Drug: insulin aspart + insulin aspart protamin
insulin as requested
Other Name: novomix
Placebo Comparator: 2P
Placebo + NovoMix
Drug: insulin aspart + insulin aspart protamin
insulin as requested
Other Name: novomix
Experimental: 3M
Metformin + 4x therapy
Drug: metformin
metformin tablets 2 g x 2
Other Name: glucophage
Drug: insulin detemir
insulin as requested
Other Name: Levemir
Drug: Insulin aspart
insulin as requested
Other Name: NovoRapid
Placebo Comparator: 3P
Placebo + 4x therapy
Drug: insulin detemir
insulin as requested
Other Name: Levemir
Drug: Insulin aspart
insulin as requested
Other Name: NovoRapid


Outcome Measures

Primary Outcome Measures :
  1. Carotid intima media thickness [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT00657943


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Gentofte Sygehus
Gentofte, Denmark, 2820
Steno Diabetes Center
Gentofte, Denmark, 2820
Herlev Hospital
Herlev, Denmark, 2830
Hillerod Sygehus
Hillerod, Denmark, 3400
Hvidovre Hospital
Hvidovre, Denmark, 2650
Køge Sygehus
Koge, Denmark, 4600
Sponsors and Collaborators
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
Investigators
Principal Investigator: Thomas Almdal, MD DMSc Hvidovre University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lise Tarnow, professor, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT00657943     History of Changes
Other Study ID Numbers: EudraCT 2007-006665-33
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Lise Tarnow, Steno Diabetes Center:
carotid
intima
media
thickness
insulin
metformin

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Metformin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants