Abstract
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).