Status:
COMPLETED
The Copenhagen Insulin and Metformin Therapy Trial
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Hvidovre University Hospital
Hillerod Hospital, Denmark
Conditions:
Type 2 Diabetes
Atherosclerosis
Eligibility:
All Genders
30+ years
Phase:
PHASE4
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 metfo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00657943
Start Date
April 1 2008
End Date
December 1 2012
Last Update
February 4 2014
Active Locations (9)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
4
Gentofte Sygehus
Gentofte Municipality, Denmark, 2820