Study Design and Baseline Characteristics of Patients with T2DM in the Post-marketing Safety Study of Dulaglutide in China (TRUST-CHN)

Abstract

Background TRUST-CHN is a prospective, post-marketing safety study in patients with type 2 diabetes mellitus (T2DM) in China to evaluate the safety and effectiveness of dulaglutide in real-world clinical practice. We report here the study design and baseline characteristics of enrolled patients. Methods The study design was described, and baseline data were analyzed, including demographic characteristics, T2DM duration, comorbidities, dulaglutide treatment patterns, and concomitant medications. Results For the present analysis of this ongoing study, data were collected from January 2020 to November 2021. A total of 3313 patients were enrolled, of whom 3294 patients were included in the safety analysis. In total, 1047 patients had a prior history of dulaglutide use before being enrolled in the study. The mean (standard deviation [SD]) age of study subjects was 50.1 (13.2) years, 85.1% were aged < 65 years; 67.9% were male, and 35.9% had an education of university level or higher. Mean (SD) duration of T2DM was 6.4 (6.7) years. Baseline mean (SD) glycated hemoglobin was 8.8% (2.2%), and mean (SD) body mass index was 28.1 (4.1) kg/m 2 . A total of 2867 (87%) patients had at least one comorbidity, the most frequently reported of which were overweight/obesity (87.1%), hyperlipidemia (50.5%), hypertension (47.9%), diabetic neuropathy (18.9%), and coronary artery disease (15.7%). Almost all (99.7%) patients were treated with 1.5 mg dulaglutide; at baseline, 24.8% were treated with this medication as monotherapy and 75.2% in combination therapy with other medications, including metformin (42.3%), sodium glucose co-transporter2 inhibitor (26.7%), insulin (18.3%), α-glucosidase inhibitor (13.1%), sulfonylurea (5.3%), dipeptidyl peptidase 4 inhibitor (4.4%), glucagon-like peptide 1 receptor agonist (2.7%), and thiazolidinedione (2.4%). Conclusion The present analysis revealed real-world baseline characteristics of patients with T2DM in China who use dulaglutide enrolled in TRUST-CHN. These data will enable further exploration of the characteristics of patients with T2DM in China and provide an insight on the current use of dulaglutide in clinical practice. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01268-2.

Safety and effectiveness of dulaglutide in Chinese adults with type 2 diabetes mellitus in a real‐world setting: A prospective, observational post‐marketing study

“…Details of the study design have been published previously 13 . Briefly, adults (≥18 years of age) with T2DM who were prescribed dulaglutide in routine clinical practice were eligible if they were not participating in an interventional clinical study, and were not/had no intention of becoming pregnant or breastfeeding during the study.…”

Dulaglutide (Trulicity)-Induced Acute Pancreatitis: A Case Report

“…Dulaglutide is typically used in combination with other oral hypoglycemic medications, such as metformin, and has been found to cause weight loss due to its ability to cause early satiety by slowing gastric emptying. This weight loss potential has made GLP-1 analogs widely used in diabetic patients [ 4 ].…”