[HTML][HTML] Distribution and characteristics of newly-defined subgroups of type 2 diabetes in randomised clinical trials: Post hoc cluster assignment analysis of over …
W Landgraf, G Bigot, S Hess, O Asplund… - Diabetes Research and …, 2022 - Elsevier
W Landgraf, G Bigot, S Hess, O Asplund, L Groop, E Ahlqvist, A Käräjämäki, DR Owens…
Diabetes Research and Clinical Practice, 2022•ElsevierAims 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 …
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 …
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.
Elsevier
