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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

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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...

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Published in: Diabetes Research and Clinical Practice
ISSN: 0168-8227
Published: Elsevier BV 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa60645
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spelling 2022-09-09T16:28:34.7085655 v2 60645 2022-07-27 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 2fd4b7c3f82c6d3bd546eff61ff944e9 0000-0003-1002-1238 David Owens David Owens true false 2022-07-27 BMS 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. Journal Article Diabetes Research and Clinical Practice 190 110012 Elsevier BV 0168-8227 Cluster; C-peptide; Type 2 diabetes; Randomised clinical trial; Real-world studies 1 8 2022 2022-08-01 10.1016/j.diabres.2022.110012 COLLEGE NANME Biomedical Sciences COLLEGE CODE BMS Swansea University 2022-09-09T16:28:34.7085655 2022-07-27T12:17:57.0992032 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Wolfgang Landgraf 1 Gregory Bigot 2 Sibylle Hess 3 Olof Asplund 4 Leif Groop 5 Emma Ahlqvist 6 Annemari Käräjämäki 7 David Owens 0000-0003-1002-1238 8 Brian M. Frier 9 Geremia B. Bolli 10 60645__24858__cde53ab96ba746f4b32eb22a7a1ef0ba.pdf 60645_VoR.pdf 2022-08-05T11:55:53.5460273 Output 2002647 application/pdf Version of Record true © 2022 The Authors. This is an open access article under the CC BY-NC-ND license true eng http://creativecommons.org/licenses/by-nc-nd/4.0/
title 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
spellingShingle 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
David Owens
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv 2fd4b7c3f82c6d3bd546eff61ff944e9
author_id_fullname_str_mv 2fd4b7c3f82c6d3bd546eff61ff944e9_***_David Owens
author David Owens
author2 Wolfgang Landgraf
Gregory Bigot
Sibylle Hess
Olof Asplund
Leif Groop
Emma Ahlqvist
Annemari Käräjämäki
David Owens
Brian M. Frier
Geremia B. Bolli
format Journal article
container_title Diabetes Research and Clinical Practice
container_volume 190
container_start_page 110012
publishDate 2022
institution Swansea University
issn 0168-8227
doi_str_mv 10.1016/j.diabres.2022.110012
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description 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.
published_date 2022-08-01T04:18:55Z
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