Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.

INTRODUCTION: Gastrointestinal (GI) events are a common side effect of glucagon-like peptide 1 (GLP-1) receptor agonists (RA) class. This post hoc analysis assessed the characteristics of GI adverse events in Chinese patients with type 2 diabetes (T2D) who were treated with once-weekly dulaglutide from two randomized clinical trials. METHODS: Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included. Descriptive statistics were used to present the data. The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated. RESULTS: A total of 787 Chinese patients with T2D were included in this analysis. Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE). The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively. A total of 12 patients (1.5%) discontinued the dulaglutide treatment as a result of GI TEAEs. The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively. The incidence of GI TEAEs was more frequent during the first 2 weeks of dulaglutide treatment; however, the incidence declined rapidly after 2 weeks and remained low until week 26. CONCLUSIONS: Most of the GI TEAEs associated with once-weekly dulaglutide (1.5 mg and 0.75 mg) were mild to moderate in severity. The incidence of GI TEAEs was more pronounced during the first 2 weeks of dulaglutide treatment but declined rapidly as treatment continued, and was low at week 26, indicating that dulaglutide was well tolerated in Chinese patients with T2D. TRIAL REGISTRATION: NCT01648582 and NCT01644500.