The Copenhagen Insulin and Metformin Therapy Trial

Type 2 Diabetes Clinical Trial

— CIMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657943
• Other study ID #: EudraCT 2007-006665-33
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2008
• Last updated: February 2, 2014
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Type 2 Diabetes

Intervention

Drug:
• metformin
metformin tablets 2 g x 2
• insulin detemir
insulin as requested
• insulin aspart + insulin aspart protamin
insulin as requested
• Insulin aspart
insulin as requested

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Frederiksberg Hospital	Frederiksberg
Denmark	Gentofte Sygehus	Gentofte
Denmark	Steno Diabetes Center	Gentofte
Denmark	Herlev Hospital	Herlev
Denmark	Hillerod Sygehus	Hillerod
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Køge Sygehus	Koge

Sponsors (11)

Lead Sponsor	Collaborator
Steno Diabetes Center	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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid intima media thickness		18 months	No
Secondary	adverse events		18 months	Yes