The Copenhagen Insulin and Metformin Therapy Trial (CIMT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00657943 |
Recruitment Status :
Completed
First Posted : April 14, 2008
Last Update Posted : February 4, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |
- Carotid intima media thickness [ Time Frame: 18 months ]
- adverse events [ Time Frame: 18 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Thomas Almdal, MD DMSc | Hvidovre University Hospital |
Responsible Party: | Lise Tarnow, professor, Steno Diabetes Center Copenhagen |
ClinicalTrials.gov Identifier: | NCT00657943 |
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 |
carotid intima media |
thickness insulin metformin |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Insulin Insulin, Globin Zinc Metformin Insulin Aspart |
Insulin, Long-Acting Insulin degludec, insulin aspart drug combination Insulin Detemir Protamines Hypoglycemic Agents Physiological Effects of Drugs Heparin Antagonists Molecular Mechanisms of Pharmacological Action Coagulants |