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

Abstract

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.

Effects of a Dulaglutide plus Calorie-Restricted Diet versus a Calorie-Restricted Diet on Visceral Fat and Metabolic Profiles in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial

“…Concerning adverse events, GI events are common side effects of GLP1 RAs. In our study, 37.14% of the PCOS participants with dulaglutide treatment reported at least one GI TEAE, which was comparable with those observed in individuals with T2D receiving 1.5 mg once-weekly dulaglutide as described in the Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) trials [ 46 , 47 ]. Compared with the AWARD studies [ 46 , 47 ], the current study had higher incidences of nausea, vomiting, constipation, and loss of appetite.…”

“…In our study, 37.14% of the PCOS participants with dulaglutide treatment reported at least one GI TEAE, which was comparable with those observed in individuals with T2D receiving 1.5 mg once-weekly dulaglutide as described in the Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) trials [ 46 , 47 ]. Compared with the AWARD studies [ 46 , 47 ], the current study had higher incidences of nausea, vomiting, constipation, and loss of appetite. A possible explanation for this might be the younger study population, and more GI events might have occurred in the higher baseline BMI subgroups [ 48 ].…”

ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide

“…Bettge and colleagues reported that only a small percentage (\15%) of patients in their study discontinued dulaglutide treatment in the first year of treatment [30]. According to a very recent observation on Chinese patients with T2D (N = 787) who were treated with dulaglutide once weekly in two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) [31], most of the gastrointestinal AEs associated with dulaglutide were mild to moderate in severity; their incidence was more pronounced during the first 2 weeks of dulaglutide treatment but declined rapidly as treatment continued. Healthcare providers should take gastrointestinal-related issues into account when prescribing a GLP-1RA, but disparities between patient experiences and physician perceptions have been revealed, suggesting gaps in physician-patient communication [32].…”