Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis

Abstract

Introduction: To evaluate the efficacy and safety of dulaglutide 0.75 and 1.5 mg in patients with type 2 diabetes mellitus (T2DM) by baseline glycated hemoglobin (HbA1c) \ 8.5% or C 8.5% after 26 weeks of treatment.Methods: Assessment of the Weekly Admin-istRation of dulaglutide in Diabetes (AWARD) China 1 (CHN1) study (NCT01644500, n = 556) included patients on dulaglutide vs. glimepiride who were treatment naïve or on monotherapy but discontinued therapy. AWARD-CHN2 (NCT01 648582, n = 591) patients were on dulaglutide vs. insulin glargine and continued on metformin and/or sulfonylurea. Mean daily dose of glimepiride and insulin glargine was 2.51 mg and 21.0 IU, respectively. Post hoc analyses were conducted based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the Chinese population. Change from baseline in HbA1c and body weight was analyzed by individual study. Results: In the two studies, 70.1% of patients in AWARD-CHN1 and 59.7% in AWARD-CHN2 had baseline HbA1c \ 8.5% (mean HbA1c 7.4% and 7.6%, respectively) and 29.9% in AWARD-CHN1 and 40.3% in AWARD-CHN2 had baseline HbA1c C 8.5% (mean HbA1c 9.2% and 9.4%, respectively). In AWARD-CHN1, the HbA1c reductions at 26 weeks with baseline HbA1c \ 8.5% and C 8.5%, respectively, were dulaglutide 1.5 mg: -1.1% and -2.2%; dulaglutide 0.75 mg: -0.9% and -2.0%; glimepiride: -0.7% and -1.4%. In AWARD-CHN2, the HbA1c reductions at 26 weeks with baseline HbA1c \ 8.5% and C 8.5%, respectively, were dulaglutide 1.5 mg: -1.2% and -2.3%; dulaglutide 0.75 mg: -1.0% and -1.7%; and insulin glargine: -0.6% and -1.7%. Irrespective of baseline HbA1c, body Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11439636.Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13300-020-00804-2) contains supplementary material, which is available to authorized users.

Glycaemic Control in People with Diabetes Starting Treatment with Fast-Acting Insulin Aspart: a US Database Study

“…However, HbA1c was significantly reduced in individuals with T1D or T2D with a baseline HbA1c level > 8.5%; this was not observed for those who already had better glycaemic control before switching to faster aspart (baseline HbA1c ≤ 8.5%). This is in agreement with previous studies, which found that patients with a baseline HbA1c of ≤ 8.5% had a lesser reduction in HbA1c in response to insulin treatment, compared with those with baseline HbA1c > 8.5% [ 20 , 21 ]. Additional analyses showed that an improvement in HbA1c can be achieved with faster aspart, regardless of prior exposure to SGLT2i or GLP-1 RA.…”

Study Design and Baseline Characteristics of Patients with T2DM in the Post-marketing Safety Study of Dulaglutide in China (TRUST-CHN)

“…In a post-hoc analysis of two Chinese patient populations with T2DM, the efficacy of dulaglutide was further evaluated according to baseline HbA1c < 8.5% or ≥ 8.5% after 26 weeks of treatment [ 26 ]. Dulaglutide achieved a greater HbA1c reduction, combined with weight loss and lower risk of hypoglycemia, compared with active comparators (glimepiride and insulin glargine) regardless of baseline HbA1c; patients with a higher baseline HbA1c did achieve greater HbA1c reductions [ 26 ].…”

“…In a post-hoc analysis of two Chinese patient populations with T2DM, the efficacy of dulaglutide was further evaluated according to baseline HbA1c < 8.5% or ≥ 8.5% after 26 weeks of treatment [ 26 ]. Dulaglutide achieved a greater HbA1c reduction, combined with weight loss and lower risk of hypoglycemia, compared with active comparators (glimepiride and insulin glargine) regardless of baseline HbA1c; patients with a higher baseline HbA1c did achieve greater HbA1c reductions [ 26 ]. In the same Chinese populations, another post-hoc analysis showed that dulaglutide improved glycemic control combined with a slight body weight reduction and low hypoglycemia risk in patients with a BMI < 25 kg/m 2 ; this result suggests that BMI is not a necessary consideration for dulaglutide treatment in Chinese patients with T2DM [ 27 ].…”

Long-Term Cost-Effectiveness Analysis of Once-Weekly Semaglutide versus Dulaglutide in Patients with Type 2 Diabetes with Inadequate Glycemic Control in China

“…The effect of basal insulin was applied from the second year using data of insulin glargine. The effect of insulin glargine on HbA 1c , BMI, and hypoglycemic events among Chinese patients with T2D were derived from the study of Yu et al [37].…”