Efficacy 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

Abstract

Aims/IntroductionTo investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.Materials and MethodsThis 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%).ResultsDulaglutide 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.ConclusionsThese findings support once‐weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.

Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies

“…It is a little higher in AWARD-CHN2, which may be related to oral antihyperglycemic medication background use (i.e., metformin and/or sulfonylurea) in AWARD-CHN2 patients, suggesting that administration of dulaglutide with metformin and/or sulfonylurea may increase incidence of hypoglycemia in clinical practice in the older population. Dulaglutide was well tolerated in Chinese patients, and the incidence of TEAEs was generally low [10,11]. GI TEAEs are the most common AEs in patients using GLP-1RAs, and in accordance, this analysis shows that GI adverse events, particularly diarrhea, were the most common TEAEs in the present study [25].…”

“…Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) enhance insulin secretion and suppress glucagon secretion in a glucose-dependent manner [7] and impart low risk of hypoglycemia [8] and could be considered for the management of glycemic control in older people with T2D with either previous cardiovascular disease or cardiovascular risk factors [9]. Dulaglutide, a once-weekly GLP-1RA approved for treatment of T2D in China, has been reported to be beneficial in Chinese patients with T2D in two phase 3 trials (AWARD-CHN1 and AWARD-CHN2) [10,11].…”

Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naïve Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1

“…The most frequently reported GI TEAEs included diarrhea, nausea, and abdominal distension, with a higher incidence reported in the dulaglutide groups compared with glimepiride (Table 2). SMBG profile, insulin sensitivity, and beta cell function) were also more pronounced after treatment with dulaglutide (both doses), which is consistent with the results of an overall study [15] and Chinese population [18].…”

“…Furthermore, in the overall population study [15], the Chinese subgroup [18], and the current OAM-naïve Chinese group, there were significantly more patients attaining HbA1c \ 7.0% in the dulaglutide 1.5 mg group than in the glimepiride group (74.1% vs 57.4%, P \ 0.001 for the overall population [15]; 71.7% vs 57.5%, P = 0.005 for Chinese subgroup [18]; 86.2% vs 65.5% P = 0.002 for patients who were OAMnaïve). Moreover, in this post hoc analysis, compared to glimepiride, a significantly greater proportion of patients treated with dulaglutide (1.5 mg and 0.75 mg) reached a target HbA1c of \ 7.0%, with greater reductions in body weight and hypoglycemia at week 26.…”

Achieving the composite end‐point of glycated hemoglobin <7.0% without weight gain or hypoglycemia with once‐weekly dulaglutide in Chinese patients with type 2 diabetes: A post‐hoc analysis

“…Furthermore, the numbers of patients who attained the CE with DU (1.5/0.75 mg) and GLAR were lower after 52 weeks of treatment as compared with 26 weeks. This was due to the tail‐raising of HbA1c reduction and weight reduction at week 26, with a continuing low hypoglycemic rate at weeks 26 and 52, associated with DU.…”