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

Snaith, J. R.; Olsen, N.; Greenfield, J. R.

2023-11-20 endocrinology
10.1101/2023.11.20.23298602 medRxiv
Show abstract

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).

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