The Copenhagen Insulin and Metformin Therapy Trial

Phase 4

Completed

• Conditions: Arteriosclerosis; Atherosclerosis; Type 2 Diabetes
• Interventions: Drug: metformin; Drug: insulin detemir; Drug: insulin aspart + insulin aspart protamin; Drug: Insulin aspart

• Registration Number: NCT00657943
• Lead Sponsor: Steno Diabetes Center Copenhagen

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 available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-02
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2M	insulin aspart + insulin aspart protamin	metformin + NovoMix
2P	insulin aspart + insulin aspart protamin	Placebo + NovoMix
1M	metformin	Metformin + Levemir x1
2M	metformin	metformin + NovoMix
3P	insulin detemir	Placebo + 4x therapy
1M	insulin detemir	Metformin + Levemir x1
1P	insulin detemir	Placebo + Levemir x1
3M	Insulin aspart	Metformin + 4x therapy
3M	metformin	Metformin + 4x therapy
3M	insulin detemir	Metformin + 4x therapy
3P	Insulin aspart	Placebo + 4x therapy

Primary Outcome Measures

Name	Time	Method
Carotid intima media thickness	18 months

Secondary Outcome Measures

Name	Time	Method
adverse events	18 months

Trial Locations

Locations (9)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark

Gentofte Sygehus; 🇩🇰 Gentofte, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Hillerod Sygehus; 🇩🇰 Hillerod, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Køge Sygehus; 🇩🇰 Koge, Denmark