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

Markus Harboe Olsen*, Thomas P Almdal, Sten Madsbad, Christian Ovesen, Christian Gluud, Simone B Sneppen, Leif Breum, Christoffer Hedetoft, Thure Krarup, Louise Lundby-Christensen, Elisabeth R Mathiesen, Michael E Røder, Henrik Vestergaard, Niels Wiinberg, Janus C Jakobsen

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstract

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).

OriginalsprogEngelsk
Artikelnummer101095
Antal sider6
TidsskriftContemporary Clinical Trials Communications
Vol/bind33
DOI
StatusUdgivet - jun. 2023

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© 2023 The Authors.

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