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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
BACKGROUND: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. METHODS: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, plac...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10009439/ https://www.ncbi.nlm.nih.gov/pubmed/36923108 http://dx.doi.org/10.1016/j.conctc.2023.101095 |
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author | Olsen, Markus Harboe Almdal, Thomas P. Madsbad, Sten Ovesen, Christian Gluud, Christian Sneppen, Simone B. Breum, Leif Hedetoft, Christoffer Krarup, Thure Lundby-Christensen, Louise Mathiesen, Elisabeth R. Røder, Michael E. Vestergaard, Henrik Wiinberg, Niels Jakobsen, Janus C. |
author_facet | Olsen, Markus Harboe Almdal, Thomas P. Madsbad, Sten Ovesen, Christian Gluud, Christian Sneppen, Simone B. Breum, Leif Hedetoft, Christoffer Krarup, Thure Lundby-Christensen, Louise Mathiesen, Elisabeth R. Røder, Michael E. Vestergaard, Henrik Wiinberg, Niels Jakobsen, Janus C. |
author_sort | Olsen, Markus Harboe |
collection | PubMed |
description | BACKGROUND: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. METHODS: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137). We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. DISCUSSIONS: This statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses. TRIAL REGISTRATION: The protocol was approved by the Regional Committee on Biomedical Research Ethics (H-D-2007-112), the Danish Medicines Agency (EudraCT: 2007-006665-33 CIMT), and registered within ClinicalTrials.gov (NCT00657943, 8(th) of April 2008). |
format | Online Article Text |
id | pubmed-10009439 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-100094392023-03-14 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 Olsen, Markus Harboe Almdal, Thomas P. Madsbad, Sten Ovesen, Christian Gluud, Christian Sneppen, Simone B. Breum, Leif Hedetoft, Christoffer Krarup, Thure Lundby-Christensen, Louise Mathiesen, Elisabeth R. Røder, Michael E. Vestergaard, Henrik Wiinberg, Niels Jakobsen, Janus C. Contemp Clin Trials Commun Article BACKGROUND: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. METHODS: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137). We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. DISCUSSIONS: This statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses. TRIAL REGISTRATION: The protocol was approved by the Regional Committee on Biomedical Research Ethics (H-D-2007-112), the Danish Medicines Agency (EudraCT: 2007-006665-33 CIMT), and registered within ClinicalTrials.gov (NCT00657943, 8(th) of April 2008). Elsevier 2023-02-24 /pmc/articles/PMC10009439/ /pubmed/36923108 http://dx.doi.org/10.1016/j.conctc.2023.101095 Text en © 2023 The Authors https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Olsen, Markus Harboe Almdal, Thomas P. Madsbad, Sten Ovesen, Christian Gluud, Christian Sneppen, Simone B. Breum, Leif Hedetoft, Christoffer Krarup, Thure Lundby-Christensen, Louise Mathiesen, Elisabeth R. Røder, Michael E. Vestergaard, Henrik Wiinberg, Niels Jakobsen, Janus C. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10009439/ https://www.ncbi.nlm.nih.gov/pubmed/36923108 http://dx.doi.org/10.1016/j.conctc.2023.101095 |
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