Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2)

Abstract

Introduction To evaluate efficacy and safety data of dulaglutide in Chinese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with 1–2 oral antihyperglycemic medications (OAMs). Methods This is a subgroup analysis of a phase 3, open-label, randomized, parallel-arm, 52-week study in Chinese patients aged ≥ 18 years with T2DM who had inadequate glycemic control with OAMs (glycated hemoglobin [HbA1c] ≥ 7.0% and ≤ 11.0%). The primary endpoint was assessment of the noninferiority of dulaglutide 1.5 mg as measured by change in HbA1c, compared with insulin glargine (glargine), using a 0.4% noninferiority margin at week 26. Results A total of 607 patients from China were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or once-daily glargine. At week 26, the least squares mean (LSM) change from baseline in HbA1c was greater with dulaglutide 1.5 mg (− 1.67%) and dulaglutide 0.75 mg (− 1.31%) compared with glargine (− 1.11%). The LSM (95% confidence interval) for the difference of dulaglutide 1.5 mg and 0.75 mg vs glargine was − 0.56% (− 0.75 to − 0.37) and − 0.20% (− 0.39 to − 0.01), respectively. Both doses of dulaglutide were noninferior and superior to glargine at 26 weeks and 52 weeks (two-sided P value < 0.05). The mean body weight decreased ( P < 0.001) and total hypoglycemia rates were lower ( P < 0.05) in the dulaglutide groups compared with the glargine group. Gastrointestinal adverse events (AEs) were the most frequently reported AEs in dulaglutide groups. Conclusion Both doses of dulaglutide are efficacious and tolerable in Chinese patients with T2DM who had inadequate glycemic control on OAMs. Trial Registration ClinicalTrials.gov identifier, NCT01648582. Funding Eli Lilly and Company. Electronic Supplementary Material The online version of this article (10.1007/s13300-019-0646-y) contains supplementary material, which is available to authorized users.

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].…”

Real-world Efficacy and Safety of Dulaglutide in Korean Patients with Type 2 Diabetes Mellitus: A Retrospective Study in a Tertiary Referral Center

“…In the present study, the incidence of gastrointestinal side effects, including mainly nausea, vomiting, and dyspepsia, was similar or slightly higher than those reported in previous RCTs and real-world data [25,[30][31][32]. Self-reported hypoglycemia occurred more frequently in our study (13.4%) than in previous studies and meta-analyses [13,33,34], and all of them received sulfonylurea and/or basal insulin.…”

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

“…Evidence showed that dulaglutide was effective in a global and Asian patient population with few incidences of gastrointestinal (GI) treatment-emergent adverse events (TEAEs) [ 9 – 21 ], consistent with GI TEAEs reported in other GLP-1 RAs [ 22 ]. Previous studies with GLP-1 RAs have reported that GI adverse events occurred more frequently in lower versus higher body mass index (BMI) baseline subgroups [ 23 ], and Chinese patients with T2D have lower BMI compared with western patients [ 2 ].…”