The Copenhagen Insulin and Metformin Therapy Trial (CIMT)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
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 :	April 2008
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Carotid intima media thickness [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. adverse events [ Time Frame: 18 months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Gentofte Sygehus
Gentofte, Denmark, 2820
Steno Diabetes Center
Gentofte, Denmark, 2820
Herlev Hospital
Herlev, Denmark, 2830
Hillerod Sygehus
Hillerod, Denmark, 3400
Hvidovre Hospital
Hvidovre, Denmark, 2650
Køge Sygehus
Koge, Denmark, 4600

Sponsors and Collaborators

Steno Diabetes Center

Hvidovre University Hospital

Hillerod Hospital, Denmark

Frederiksberg University Hospital

University Hospital, Gentofte, Copenhagen

Rigshospitalet, Denmark

Bispebjerg Hospital

Herlev Hospital

Zealand University Hospital

Copenhagen Trial Unit, Center for Clinical Intervention Research

Novo Nordisk A/S

Investigators

Principal Investigator:	Thomas Almdal, MD DMSc	Hvidovre University Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lundby-Christensen L, Vaag A, Tarnow L, Almdal TP, Lund SS, Wetterslev J, Gluud C, Boesgaard TW, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Røder M, Mathiesen ER, Jensen T, Vestergaard H, Hedetoft C, Breum L, Duun E, Sneppen SB, Pedersen O, Hemmingsen B, Carstensen B, Madsbad S. Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial. BMJ Open. 2016 Feb 25;6(2):e008377. doi: 10.1136/bmjopen-2015-008377.

Lundby-Christensen L, Tarnow L, Boesgaard TW, Lund SS, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Røder M, Mathiesen ER, Jensen T, Vestergaard H, Hedetoft C, Breum L, Duun E, Sneppen SB, Pedersen O, Hemmingsen B, Carstensen B, Madsbad S, Gluud C, Wetterslev J, Vaag A, Almdal TP. Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial. BMJ Open. 2016 Feb 25;6(2):e008376. doi: 10.1136/bmjopen-2015-008376.

Responsible Party:	Lise Tarnow, professor, Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00657943 History of Changes
Other Study ID Numbers:	EudraCT 2007-006665-33
First Posted:	April 14, 2008
Last Update Posted:	February 4, 2014
Last Verified:	February 2014

Keywords provided by Lise Tarnow, Steno Diabetes Center:

carotid; intima; media	thickness; insulin; metformin

Additional relevant MeSH terms:

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Insulin, Globin Zinc; Insulin degludec, insulin aspart drug combination; Insulin; Metformin	Insulin Aspart; Insulin, Long-Acting; Insulin Detemir; Protamines; Hypoglycemic Agents; Physiological Effects of Drugs; Heparin Antagonists; Molecular Mechanisms of Pharmacological Action; Coagulants