No Cover Image

Journal article 639 views 75 downloads

Distribution and characteristics of newly-defined subgroups of type 2 diabetes in randomised clinical trials: Post hoc cluster assignment analysis of over 12,000 study participants

Wolfgang Landgraf, Gregory Bigot, Sibylle Hess, Olof Asplund, Leif Groop, Emma Ahlqvist, Annemari Käräjämäki, David Owens Orcid Logo, Brian M. Frier, Geremia B. Bolli

Diabetes Research and Clinical Practice, Volume: 190, Start page: 110012

Swansea University Author: David Owens Orcid Logo

  • 60645_VoR.pdf

    PDF | Version of Record

    © 2022 The Authors. This is an open access article under the CC BY-NC-ND license

    Download (1.91MB)

Check full text

DOI (Published version): 10.1016/j.diabres.2022.110012

Abstract

AimsNewly-defined subgroups of type 2 diabetes mellitus (T2DM) have been reported from real-world cohorts but not in detail from randomised clinical trials (RCTs).MethodsT2DM participants, uncontrolled on different pre-study therapies (n = 12.738; 82 % Caucasian; 44 % with diabetes duration > 10...

Full description

Published in: Diabetes Research and Clinical Practice
ISSN: 0168-8227
Published: Elsevier BV 2022
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa60645
Tags: Add Tag
No Tags, Be the first to tag this record!
Abstract: AimsNewly-defined subgroups of type 2 diabetes mellitus (T2DM) have been reported from real-world cohorts but not in detail from randomised clinical trials (RCTs).MethodsT2DM participants, uncontrolled on different pre-study therapies (n = 12.738; 82 % Caucasian; 44 % with diabetes duration > 10 years) from 14 RCTs, were assigned to new subgroups according to age at onset of diabetes, HbA1c, BMI, and fasting C-peptide using the nearest centroid approach. Subgroup distribution, characteristics and influencing factors were analysed.ResultsIn both, pooled and single RCTs, “mild-obesity related diabetes” predominated (45 %) with mean BMI of 35 kg/m2. “Severe insulin-resistant diabetes” was found least often (4.6 %) and prevalence of “mild age-related diabetes” (23.9 %) was mainly influenced by age at onset of diabetes and age cut-offs. Subgroup characteristics were widely comparable to those from real-world cohorts, but all subgroups showed higher frequencies of diabetes-related complications which were associated with longer diabetes duration. A high proportion of “severe insulin-deficient diabetes” (25.4 %) was identified with poor pre-study glycaemic control.ConclusionsClassification of RCT participants into newly-defined diabetes subgroups revealed the existence of a heterogeneous population of T2DM. For future RCTs, subgroup-based randomisation of T2DM will better define the target population and relevance of the outcomes by avoiding clinical heterogeneity.
Keywords: Cluster; C-peptide; Type 2 diabetes; Randomised clinical trial; Real-world studies
College: Faculty of Medicine, Health and Life Sciences
Start Page: 110012

Similar Items