The Copenhagen Insulin and Metformin Therapy Trial (CIMT)

This study has been completed.

Sponsor:

Collaborators:

Hvidovre University Hospital

Hillerod Hospital, Denmark

Frederiksberg University Hospital

University Hospital, Gentofte, Copenhagen

Rigshospitalet, Denmark

Bispebjerg Hospital

Herlev Hospital

University Hospital Koge

Copenhagen Trial Unit, Center for Clinical Intervention Research

Novo Nordisk A/S

Information provided by (Responsible Party):

Lise Tarnow, Steno Diabetes Center

ClinicalTrials.gov Identifier:

NCT00657943

First received: April 8, 2008

Last updated: February 2, 2014

Last verified: February 2014

History of Changes

Purpose

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	Intervention	Phase
Type 2 Diabetes Atherosclerosis Arteriosclerosis	Drug: metformin Drug: insulin detemir Drug: insulin aspart + insulin aspart protamin Drug: Insulin aspart	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Insulin Protamine Insulin human Insulin aspart Insulin detemir

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:

Carotid intima media thickness [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]


Enrollment:	415
Study Start Date:	April 2008
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657943

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

University Hospital Koge

Copenhagen Trial Unit, Center for Clinical Intervention Research

Novo Nordisk A/S

Investigators


Principal Investigator:	Thomas Almdal, MD DMSc	Hvidovre University Hospital

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
Study First Received:	April 8, 2008
Last Updated:	February 2, 2014
Health Authority:	Denmark: Ethics Committee Denmark: Danish Medicines Agency Denmark: Danish Dataprotection Agency

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016

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