CIMT: The Copenhagen Insulin and Metformin Therapy Trial

Sponsor

Steno Diabetes Center Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00657943

Collaborator

Hvidovre University Hospital (Other), Hillerod Hospital, Denmark (Other), Frederiksberg University Hospital (Other), University Hospital, Gentofte, Copenhagen (Other), Rigshospitalet, Denmark (Other), Bispebjerg Hospital (Other), Herlev Hospital (Other), Zealand University Hospital (Other), Copenhagen Trial Unit, Center for Clinical Intervention Research (Other), Novo Nordisk A/S (Industry)

415

Enrollment

Locations

Arms

Duration (Months)

46.1

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Atherosclerosis Arteriosclerosis	Drug: metformin Drug: insulin detemir Drug: insulin aspart + insulin aspart protamin Drug: Insulin aspart	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

415 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1M Metformin + Levemir x1	Drug: metformin metformin tablets 2 g x 2 Other Names: glucophage Drug: insulin detemir insulin as requested Other Names: Levemir
Placebo Comparator: 1P Placebo + Levemir x1	Drug: insulin detemir insulin as requested Other Names: Levemir
Experimental: 2M metformin + NovoMix	Drug: metformin metformin tablets 2 g x 2 Other Names: glucophage Drug: insulin aspart + insulin aspart protamin insulin as requested Other Names: novomix
Placebo Comparator: 2P Placebo + NovoMix	Drug: insulin aspart + insulin aspart protamin insulin as requested Other Names: novomix
Experimental: 3M Metformin + 4x therapy	Drug: metformin metformin tablets 2 g x 2 Other Names: glucophage Drug: insulin detemir insulin as requested Other Names: Levemir Drug: Insulin aspart insulin as requested Other Names: NovoRapid
Placebo Comparator: 3P Placebo + 4x therapy	Drug: insulin detemir insulin as requested Other Names: Levemir Drug: Insulin aspart insulin as requested Other Names: NovoRapid

Outcome Measures

Primary Outcome Measures

Carotid intima media thickness [18 months]

Secondary Outcome Measures

adverse events [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Rigshospitalet	Copenhagen	Denmark	2100
2	Bispebjerg Hospital	Copenhagen	Denmark	2400
3	Frederiksberg Hospital	Frederiksberg	Denmark	2000
4	Gentofte Sygehus	Gentofte	Denmark	2820
5	Steno Diabetes Center	Gentofte	Denmark	2820
6	Herlev Hospital	Herlev	Denmark	2830
7	Hillerod Sygehus	Hillerod	Denmark	3400
8	Hvidovre Hospital	Hvidovre	Denmark	2650
9	Køge Sygehus	Koge	Denmark	4600