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

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Landgraf , W , Bigot , G , Hess , S , Asplund , O , Groop , L , Ahlqvist , E , Käräjämäki , A , Owens , D R , Frier , B M & Bolli , G B 2022 , ' 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 ' , Diabetes Research and Clinical Practice , vol. 190 , 110012 . https://doi.org/10.1016/j.diabres.2022.110012

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
Author: Landgraf, Wolfgang; Bigot, Gregory; Hess, Sibylle; Asplund, Olof; Groop, Leif; Ahlqvist, Emma; Käräjämäki, Annemari; Owens, David R.; Frier, Brian M.; Bolli, Geremia B.
Contributor organization: Centre of Excellence in Complex Disease Genetics
HUS Abdominal Center
Institute for Molecular Medicine Finland
Leif Groop Research Group
Clinicum
University of Helsinki
Date: 2022-08
Language: eng
Number of pages: 8
Belongs to series: Diabetes Research and Clinical Practice
ISSN: 0168-8227
DOI: https://doi.org/10.1016/j.diabres.2022.110012
URI: http://hdl.handle.net/10138/346686
Abstract: Aims: Newly-defined subgroups of type 2 diabetes mellitus (T2DM) have been reported from real-world cohorts but not in detail from randomised clinical trials (RCTs). Methods: T2DM 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. Results: In 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. Conclusions: Classification 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.
Description: Publisher Copyright: © 2022
Subject: 3121 General medicine, internal medicine and other clinical medicine
C-peptide
Cluster
Randomised clinical trial
Real-world studies
Type 2 diabetes
INSULIN GLUCOSE CONTROL
NAIVE PEOPLE
TO-TARGET TRIAL
C -peptide
NPH INSULIN
ORAL-AGENTS
THERAPY
BASAL INSULIN
PLUS METFORMIN
HYPOGLYCEMIA
GLARGINE 100 UNITS/ML
Real -world studies
Peer reviewed: Yes
Rights: cc_by_nc_nd
Usage restriction: openAccess
Self-archived version: publishedVersion


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