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
  Purpose

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 Intervention Phase
Type 2 Diabetes
Atherosclerosis
Arteriosclerosis
Drug: metformin
Drug: insulin detemir
Drug: insulin aspart + insulin aspart protamin
Drug: Insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Carotid intima media thickness [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 415
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
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: NCT00657943

Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Rigshospitalet
Copenhagen, Denmark, 2100
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

No publications provided

Responsible Party: Lise Tarnow, professor, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT00657943     History of Changes
Other Study ID Numbers: EudraCT 2007-006665-33
Study First Received: April 8, 2008
Last Updated: February 2, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Diabetes Mellitus, Type 2
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Insulin Aspart
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014