Characteristics of subjects with type 2 diabetes enrolled in randomized controlled trials and non‐randomized controlled trials in Japan: A systematic review

• Published in: Journal of diabetes investigation Vol. 14; no. 2; pp. 236 - 246
• Main Authors: Kadowaki, Takashi, Shoji, Ayako, Taguchi, Yurie
• Format: Journal Article
• Language: English
• Published: Japan John Wiley & Sons, Inc 01.02.2023; John Wiley and Sons Inc; Wiley
• Subjects: Agonists; Blood pressure; Body mass index; Cardiovascular disease; Cholesterol; Clinical trials; Cohort analysis; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Dipeptidyl-Peptidase IV Inhibitors - pharmacology; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases - therapeutic use; Drugs; GLP-1 receptor agonists; Glucagon; Glucagon-like peptide 1; Glucagon-Like Peptide-1 Receptor; Glucose; Glucose‐lowering drugs; Glycated Hemoglobin; High density lipoprotein; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - therapeutic use; Japan; Lipoproteins; Literature reviews; Non-Randomized Controlled Trials as Topic; Original; Patient Selection; Peptidase; Peptides; Quality of life; Randomized Controlled Trials as Topic; Sodium; Sodium-glucose cotransporter; Systematic review; Trends; Triglycerides; Type 2 diabetes; Vein & artery diseases; Japan; Systematic review; Glucose-lowering drugs; Type 2 diabetes
• ISSN: 2040-1116; 2040-1124; 2040-1124
• DOI: 10.1111/jdi.13872

Aims/Introduction This study aimed to understand the characteristics of type 2 diabetes subjects enrolled in randomized controlled trials (RCTs) and non‐RCTs according to therapeutic regimens through systematic literature review. Materials and Methods PubMed and the database of the Japanese Medical Society (ICHUSHI) were searched for studies published from 2010 to 2019 reporting the efficacy and safety of glucose‐lowering drugs in Japanese individuals with suboptimally controlled type 2 diabetes, and therapeutic regimens, demographics and clinical characteristics at the baseline were extracted. We evaluated the treatment arms, not the placebo arms. Results The literature searches identified 2,656 publications, 145 of which met all eligibility criteria and included 282 eligible arms. In the past 10 years, dipeptidyl peptidase‐4 inhibitor was the most frequently studied in both RCTs and non‐RCTs. Regarding the characteristics of enrolled subjects, sodium–glucose cotransporter 2 inhibitor and glucagon‐like peptide‐1 receptor agonist have been studied more in relatively obese subjects, and insulin has been studied in higher proportion of subjects with disease duration ≥10 years. Most of the RCTs included subjects aged 55–64 years, whereas a higher proportion of dipeptidyl peptidase‐4 inhibitor and insulin arms in the non‐RCTs included those aged ≥65 years. Dipeptidyl peptidase‐4 inhibitor and sodium–glucose cotransporter 2 inhibitor were evaluated in subjects with no abnormalities in blood pressure or lipid parameters; however, only a few reports of those parameters have been assessed with glucagon‐like peptide‐1 receptor agonist and insulin. Conclusions As RCTs and non‐RCTs differ in the baseline characteristics of type 2 diabetes subjects, it is necessary to integrate and evaluate both to understand the actual treatment status of type 2 diabetes. This study shows findings from a systematic review of RCTs and non‐RCTs published in the past 10‐years on adult subjects with suboptimally controlled type 2 diabetes (T2D) despite receiving one or more glucose‐lowering drugs in Japan. The characteristics of studied subjects were different among study designs. Our study also found that subjects with older age and comorbidities were rarely included in both RCTs and non‐RCTs.