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Type 2 DiabetesPhase 4CIMTNCT00657943

The Copenhagen Insulin and Metformin Therapy Trial

A Phase 4 study testing metformin, insulin detemir and insulin aspart + insulin aspart protamin in people with Type 2 Diabetes and Atherosclerosis, run by Steno Diabetes Center Copenhagen at 9 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Type 2 Diabetes, Atherosclerosis, Arteriosclerosis
What is being tested?
metformin, insulin detemir and insulin aspart + insulin aspart protamin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
415 participants
Where
9 sitesDenmark
Study dates
Apr 2008to Dec 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Denmark9 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Bispebjerg Hospital

    Copenhagen, 2400

  • Frederiksberg Hospital

    Frederiksberg, 2000

  • Gentofte Sygehus

    Gentofte Municipality, 2820

  • Steno Diabetes Center

    Gentofte Municipality, 2820

  • Herlev Hospital

    Herlev, 2830

  • Hillerod Sygehus

    Hillerød, 3400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Køge Sygehus

    Køge, 4600

Other trials in Denmark

About this study

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

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.

Being tested
metformin, insulin detemir, insulin aspart + insulin aspart protamin, Insulin aspart
Keywords
carotid, intima, media, thickness, insulin, metformin
Medical subject headings
Diabetes Mellitus, Type 2, Atherosclerosis, Arteriosclerosis, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metforminDrug

    Also called glucophage

    metformin tablets 2 g x 2

  • insulin detemirDrug

    Also called Levemir

    insulin as requested

  • insulin aspart + insulin aspart protaminDrug

    Also called novomix

    insulin as requested

  • Insulin aspartDrug

    Also called NovoRapid

    insulin as requested

Study groups in NCT00657943
Study groupRoleWhat they receive
1MExperimentalMetformin + Levemir x1
Receives: Drug: metformin; Drug: insulin detemir
1PPlacebo comparatorPlacebo + Levemir x1
Receives: Drug: insulin detemir
2MExperimentalmetformin + NovoMix
Receives: Drug: metformin; Drug: insulin aspart + insulin aspart protamin
2PPlacebo comparatorPlacebo + NovoMix
Receives: Drug: insulin aspart + insulin aspart protamin
3MExperimentalMetformin + 4x therapy
Receives: Drug: metformin; Drug: insulin detemir; Drug: Insulin aspart
3PPlacebo comparatorPlacebo + 4x therapy
Receives: Drug: insulin detemir; Drug: Insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Carotid intima media thickness

    Measured: 18 months

Secondary outcomes (1)

  1. adverse events

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657943
Sponsor's protocol ID
EudraCT 2007-006665-33
Acronym
CIMT
Status last verified
Feb 2014
First submitted
8 Apr 2008
Last updated
4 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Olsen MH, Almdal TP, Madsbad S, Ovesen C, Gluud C, Sneppen SB, Breum L, Hedetoft C, Krarup T, Lundby-Christensen L, Mathiesen ER, Roder ME, Vestergaard H, Wiinberg N, Jakobsen JC. Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial - A detailed statistical analysis plan. Contemp Clin Trials Commun. 2023 Feb 24;33:101095. doi: 10.1016/j.conctc.2023.101095. eCollection 2023 Jun.

    PubMed 36923108

  • Hansen CS, Lundby-Christiansen L, Tarnow L, Gluud C, Hedetoft C, Thorsteinsson B, Hemmingsen B, Wiinberg N, Sneppen SB, Lund SS, Krarup T, Madsbad S, Almdal T, Carstensen B, Jorgensen ME; CIMT study group. Metformin may adversely affect orthostatic blood pressure recovery in patients with type 2 diabetes: substudy from the placebo-controlled Copenhagen Insulin and Metformin Therapy (CIMT) trial. Cardiovasc Diabetol. 2020 Sep 26;19(1):150. doi: 10.1186/s12933-020-01131-3.

    PubMed 32979921

  • Nordklint AK, Almdal TP, Vestergaard P, Lundby-Christensen L, Boesgaard TW, Breum L, Gade-Rasmussen B, Sneppen SB, Gluud C, Hemmingsen B, Jensen T, Krarup T, Madsbad S, Mathiesen ER, Perrild H, Tarnow L, Thorsteinsson B, Vestergaard H, Lund SS, Eiken P. The effect of metformin versus placebo in combination with insulin analogues on bone mineral density and trabecular bone score in patients with type 2 diabetes mellitus: a randomized placebo-controlled trial. Osteoporos Int. 2018 Nov;29(11):2517-2526. doi: 10.1007/s00198-018-4637-z. Epub 2018 Jul 19.

    PubMed 30027438

  • 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, Roder 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.

    PubMed 26916685

  • Lundby-Christensen L, Tarnow L, Boesgaard TW, Lund SS, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Roder 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.

    PubMed 26916684

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metformin, insulin detemir and insulin aspart + insulin aspart protamin in people with Type 2 Diabetes and Atherosclerosis, run by Steno Diabetes Center Copenhagen at 9 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carotid intima media thickness (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00657943, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.

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