The Copenhagen Insulin and Metformin Therapy Trial

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Collaborators: Bispebjerg Hospital; Copenhagen Trial Unit, Center for Clinical Intervention Research; Frederiksberg University Hospital; Herlev Hospital; Hillerod Hospital, Denmark; Hvidovre University Hospital; Novo Nordisk A/S; Rigshospitalet, Denmark; University Hospital Koge; University Hospital, Gentofte, Copenhagen; Zealand University Hospital
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Long-Acting; Metformin; Protamines

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