Statistical Analysis Plan for the INTIMET study (Insulin Resistance in Type 1 Diabetes Managed with Metformin)

This document provides the full statistical analysis plan (SAP) for the INTIMET study (Insulin Resistance in Type 1 Diabetes Managed with Metformin), a randomised double-blinded placebo-controlled trial, designed to evaluate the effect of metformin on insulin resistance and cardiometabolic health in type 1 diabetes. This trial was prospectively registered within the Australian and New Zealand Clinical Trials Registry (ACTRN12619001440112). The study protocol has previously been published (Snaith JR et al, Diabetic Medicine 2021).