Open AccessEfficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study
Author(s) -
Shi Li Xin,
Liu Xiao Min,
Shi Yong Quan,
Li Quan Min,
Ma Jian Hua,
Li Yan Bing,
Du Li Ying,
Wang Feng,
Chen Lu Lu
Publication year - 2020
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.13075
Subject(s) - glimepiride , dulaglutide , medicine , glycated hemoglobin , type 2 diabetes , post hoc analysis , glycemic , gastroenterology , diabetes mellitus , endocrinology , exenatide
Abstract Aims/Introduction To investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes. Materials and Methods This was a post‐hoc analysis of a Chinese randomized, double‐blind, non‐inferiority, phase III study. Patients ( n = 572) with inadequate glycemic control received dulaglutide 1.5 mg ( n = 189) or 0.75 mg ( n = 194) once‐weekly or glimepiride (1–3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non‐inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non‐inferiority margin 0.4%). Results Dulaglutide 1.5 mg and 0.75 mg were non‐inferior ( P < 0.001) and superior ( P ≤ 0.002) versus glimepiride for the change in glycated hemoglobin from baseline to week 26. The least‐squares mean differences (95% confidence interval) versus glimepiride were dulaglutide 1.5 mg, −0.53% (−0.74, −0.32) and dulaglutide 0.75 mg, −0.32% (−0.53, −0.12). Significantly more patients attained glycated hemoglobin <7.0% at week 26 in the dulaglutide 1.5 mg (71.7%) versus the glimepiride (57.5%; P = 0.005) group. The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group ( P < 0.01). The overall incidence and rate of hypoglycemia were lower in both of the dulaglutide groups versus the glimepiride group. At week 26, bodyweight had increased from baseline in the glimepiride group and decreased from baseline in both dulaglutide groups. The most frequent gastrointestinal drug‐related adverse events with dulaglutide were diarrhea, abdominal distension, nausea and vomiting. Conclusions These findings support once‐weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.