The Copenhagen Insulin and Metformin Therapy Trial (CIMT)

Steno Diabetes Centers

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes; Arteriosclerosis; Atherosclerosis

Treatments: Drug: Insulin aspart; Drug: insulin detemir; Drug: metformin; Drug: insulin aspart + insulin aspart protamin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00657943

EudraCT 2007-006665-33

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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415 participants in 6 patient groups, including a placebo group

1M

Experimental group

Description:

Metformin + Levemir x1

Treatment:

Drug: metformin

Drug: insulin detemir

1P

Placebo Comparator group

Description:

Placebo + Levemir x1

Treatment:

Drug: insulin detemir

2M

Experimental group

Description:

metformin + NovoMix

Treatment:

Drug: insulin aspart + insulin aspart protamin

Drug: metformin

2P

Placebo Comparator group

Description:

Placebo + NovoMix

Treatment:

Drug: insulin aspart + insulin aspart protamin

3M

Experimental group

Description:

Metformin + 4x therapy

Treatment:

Drug: metformin

Drug: insulin detemir

Drug: Insulin aspart

3P

Placebo Comparator group

Description:

Placebo + 4x therapy

Treatment:

Drug: insulin detemir

Drug: Insulin aspart