The Copenhagen Insulin and Metformin Therapy Trial (CIMT)
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| ClinicalTrials.gov Identifier: NCT00657943 |
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Recruitment Status :
Completed
First Posted : April 14, 2008
Last Update Posted : February 4, 2014
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Sponsor:
Steno Diabetes Center
Collaborators:
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
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1M
Metformin + Levemir x1
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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
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Drug: insulin detemir
insulin as requested
Other Name: Levemir |
|
Experimental: 2M
metformin + NovoMix
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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 |
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Experimental: 3M
Metformin + 4x therapy
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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 |
Primary Outcome Measures :
- Carotid intima media thickness [ Time Frame: 18 months ]
Secondary Outcome Measures :
- adverse events [ Time Frame: 18 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| 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:
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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 |