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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.
- Source :
-
Diabetes Research & Clinical Practice . Aug2022, Vol. 190, pN.PAG-N.PAG. 1p. - Publication Year :
- 2022
-
Abstract
- <bold>Aims: </bold>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).<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 01688227
- Volume :
- 190
- Database :
- Academic Search Index
- Journal :
- Diabetes Research & Clinical Practice
- Publication Type :
- Academic Journal
- Accession number :
- 158886444
- Full Text :
- https://doi.org/10.1016/j.diabres.2022.110012