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
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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. / 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.
In: Contemporary Clinical Trials Communications, Vol. 33, 101095, 2023.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Olsen, Markus Harboe
AU - Almdal, Thomas P.
AU - Madsbad, Sten
AU - Ovesen, Christian
AU - Gluud, Christian
AU - Sneppen, Simone B.
AU - Breum, Leif
AU - Hedetoft, Christoffer
AU - Krarup, Thure
AU - Lundby-Christensen, Louise
AU - Mathiesen, Elisabeth R.
AU - Røder, Michael E.
AU - Vestergaard, Henrik
AU - Wiinberg, Niels
AU - Jakobsen, Janus C.
N1 - Publisher Copyright: © 2023 The Authors
PY - 2023
Y1 - 2023
N2 - 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, 8th of April 2008).
AB - 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, 8th of April 2008).
KW - Clinical outcomes
KW - Detailed statistical analysis plan
KW - Insulin
KW - Metformin
KW - Quality of life
KW - Randomised clinical trial
KW - Type 2 diabetes
U2 - 10.1016/j.conctc.2023.101095
DO - 10.1016/j.conctc.2023.101095
M3 - Journal article
C2 - 36923108
AN - SCOPUS:85149328224
VL - 33
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
SN - 2451-8654
M1 - 101095
ER -
ID: 339138182