Dataset Information

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

ABSTRACT:

Introduction

Glucagon-like peptide (GLP)-1 receptor agonists are glucose-lowering agents associated with weight loss, cardiovascular benefits, and low hypoglycemic risk and are recommended by recent guidelines as first-line therapy for some patients with type 2 diabetes (T2D). This post hoc analysis of the AWARD-CHN1 study compared the efficacy and safety of once-weekly dulaglutide with glimepiride in oral antihyperglycemic medication (OAM)-naïve Chinese patients with T2D.

Methods

AWARD-CHN1 was a phase 3, double-blind study with 737 patients randomized 1:1:1 to once-weekly dulaglutide (1.5 or 0.75 mg) or glimepiride (1-3 mg/day). This is a post hoc analysis of AWARD-CHN1 based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the OAM-naïve Chinese population.

Results

There were 264 OAM-naïve Chinese patients included in this analysis (dulaglutide 1.5 mg, n = 87; dulaglutide 0.75 mg, n = 90; glimepiride, n = 87). A greater glycated hemoglobin (HbA1c) reduction from baseline was observed with dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 2.02% and - 1.84% vs - 1.37%, respectively; both P < 0.001). Significantly more patients in dulaglutide 1.5 mg and 0.75 mg groups achieved HbA1c targets < 7.0% compared to glimepiride (86.2% and 81.1% vs 65.5%; P = 0.002 and P = 0.026, respectively). Beta cell function was significantly increased for dulaglutide groups compared to glimepiride. Mean body weight was significantly reduced for dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 1.40 kg and - 0.96 kg vs + 0.73 kg, respectively; both P < 0.001). Through 26 weeks, 7.9%, 4.2%, and 18.2% of patients reported hypoglycemia, and 40.4%, 23.2%, and 8.0% of patients reported at least one gastrointestinal treatment emergent adverse event, in dulaglutide 1.5 mg, 0.75 mg, and glimepiride groups, respectively.

Conclusions

In this post hoc analysis, dulaglutide was effective in reducing both HbA1c and weight with favorable tolerability and safety profile, which is consistent with results seen in larger international dulaglutide monotherapy studies.

Trial registration

ClinicalTrials.gov NCT01644500.

SUBMITTER: Li YM

PROVIDER: S-EPMC7192982 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:This analysis evaluated the efficacy and safety of dulaglutide in Chinese patients with type 2 diabetes (T2D) aged ??60 and <?60 years. METHODS:This post hoc analysis included patients with T2D enrolled in two phase 3 clinical trials AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582) of dulaglutide 0.75 and 1.5 mg. Patients were categorized into two groups (??60 and <?60 years). Efficacy outcomes (change in glycated hemoglobin [HbA1c], fasting blood glucose [FBG], and weight; percentage of patients achieving HbA1c target [<?7.0%]) and safety outcomes (incidence of hypoglycemia and gastrointestinal treatment-emergent adverse events [GI TEAEs]) at 26 weeks were evaluated for each age group in both trials. RESULTS:A total of 766 patients (??60 years, n?=?222;?<?60 years, n?=?544) were included in the study. A similar reduction of HbA1c was observed in both age groups: AWARD-CHN1, 1.5 mg (least squares mean [LSM] 95% confidence interval [CI] ??60 years: -?1.45% [-?1.69, -?1.21%] and <?60 years: -?1.43% [-?1.59, -?1.28%]) and 0.75 mg (??60 years: -?1.29% [-?1.53, -?1.05%] and <?60 years: -?1.18% [-?1.33, -?1.03%]); AWARD-CHN2, 1.5 mg (??60 years: -?1.60% [-?1.83, -?1.36%] and <?60 years: -?1.64% [-?1.80, -?1.49%]) and 0.75 mg (??60 years: -?1.31% [-?1.55, -?1.08%] and <?60 years: -?1.33% [-?1.48, -?1.17%]). Dulaglutide showed a reduction in HbA1c as early as 4 weeks after initiation of treatment, which was maintained over 26 weeks in both age groups. The percentage of patients achieving HbA1c target?<?7.0% at 26 weeks was also similar in both age groups. Incidence of hypoglycemia and GI TEAEs was low in each age group. CONCLUSION:Treatment with once-weekly dulaglutide improved glycemic control in patients with T2D aged ??60 years and <?60 years and was well tolerated in older patients, suggesting it can be considered a safe and effective treatment option for use in older patients with T2D. TRIAL REGISTRATION:AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582).

Project description:IntroductionWe evaluated the effect of dulaglutide on the relative contributions of fasting glucose (FG) and postprandial glucose (PPG) to overall hyperglycemia in patients with type 2 diabetes (T2D), and assessed responses to dulaglutide versus insulin glargine (glargine) in patients with different baseline glycemic patterns.MethodsThis post-hoc analysis of the phase 3 AWARD-CHN2 trial included data from 560 Chinese patients with uncontrolled T2D who received once-weekly dulaglutide (1.5 or 0.75 mg) or once-daily glargine for 26 weeks. The relative contributions of FG and PPG to overall hyperglycemia across different glycated hemoglobin (HbA1c) categories were calculated using the area under the curve of 7-point self-monitored blood glucose profiles. Patients were also categorized into four subgroups according to median baseline FG (cutoff 8.9 mmol/L) and PPG (cutoff 12.5 mmol/L): low FG/low PPG, low FG/high PPG, high FG/low PPG and high FG/high PPG. Changes in glycemic parameters and body weight were calculated for patients in each subgroup.ResultsAmong patients receiving dulaglutide, higher HbA1c was associated with higher relative contributions of FG and lower relative contributions of PPG to overall hyperglycemia at baseline and week 26 of dulaglutide treatment. After 26 weeks, dulaglutide 1.5 mg led to statistically greater decreases in HbA1c from baseline versus glargine in most subgroups, including the high FG subgroups, and a numerically greater decrease in HbA1c was observed in the low FG/high PPG subgroup. Across all subgroups, higher proportions of patients achieved HbA1c ≤ 6.5% with dulaglutide 1.5 mg than with glargine (all P < 0.05). Dulaglutide 1.5 mg showed better control of body weight than glargine in all subgroups (all P < 0.05).ConclusionsDulaglutide reduced HbA1c through reductions in both FG and PPG across HbA1c categories in T2D patients with uncontrolled hyperglycemia. Furthermore, treatment with dulaglutide provided a greater reduction in HbA1c than glargine, regardless of baseline FG and PPG levels.