Study Results
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Basic Information
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COMPLETED
PHASE4
415 participants
INTERVENTIONAL
2008-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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1M
Metformin + Levemir x1
metformin
metformin tablets 2 g x 2
insulin detemir
insulin as requested
1P
Placebo + Levemir x1
insulin detemir
insulin as requested
2M
metformin + NovoMix
metformin
metformin tablets 2 g x 2
insulin aspart + insulin aspart protamin
insulin as requested
2P
Placebo + NovoMix
insulin aspart + insulin aspart protamin
insulin as requested
3M
Metformin + 4x therapy
metformin
metformin tablets 2 g x 2
insulin detemir
insulin as requested
Insulin aspart
insulin as requested
3P
Placebo + 4x therapy
insulin detemir
insulin as requested
Insulin aspart
insulin as requested
Interventions
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metformin
metformin tablets 2 g x 2
insulin detemir
insulin as requested
insulin aspart + insulin aspart protamin
insulin as requested
Insulin aspart
insulin as requested
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Hillerod Hospital, Denmark
OTHER
Frederiksberg University Hospital
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Rigshospitalet, Denmark
OTHER
Bispebjerg Hospital
OTHER
Herlev Hospital
OTHER
Zealand University Hospital
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Novo Nordisk A/S
INDUSTRY
Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Lise Tarnow
professor
Principal Investigators
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Thomas Almdal, MD DMSc
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Locations
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Rigshospitalet
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Frederiksberg Hospital
Frederiksberg, , Denmark
Gentofte Sygehus
Gentofte Municipality, , Denmark
Steno Diabetes Center
Gentofte Municipality, , Denmark
Herlev Hospital
Herlev, , Denmark
Hillerod Sygehus
Hillerød, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Køge Sygehus
Køge, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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EudraCT 2007-006665-33
Identifier Type: -
Identifier Source: org_study_id
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