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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:
Hvidovre University Hospital
Hillerod Hospital, Denmark
Frederiksberg University Hospital
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Bispebjerg Hospital
Herlev Hospital
Zealand University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE April 8, 2008
First Posted Date  ICMJE April 14, 2008
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
Carotid intima media thickness [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00657943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
adverse events [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Copenhagen Insulin and Metformin Therapy Trial
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Atherosclerosis
  • Arteriosclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2014)
415
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2008)
900
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00657943
Other Study ID Numbers  ICMJE EudraCT 2007-006665-33
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lise Tarnow, Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE
  • Hvidovre University Hospital
  • Hillerod Hospital, Denmark
  • Frederiksberg University Hospital
  • University Hospital, Gentofte, Copenhagen
  • Rigshospitalet, Denmark
  • Bispebjerg Hospital
  • Herlev Hospital
  • Zealand University Hospital
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Thomas Almdal, MD DMSc Hvidovre University Hospital
PRS Account Steno Diabetes Center Copenhagen
Verification Date February 2014

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