OBJECTIVE: The aim of this post hoc analysis was to assess the efficacy and safety of once-weekly dulaglutide in Hispanic/Latino patients with type 2 diabetes (T2D) in phase 3 AWARD trials 1 to 6. METHODS: Hispanic/Latino data at Week 26 were pooled across studies for each dulaglutide dose to analyze the change from baseline in glycosylated hemoglobin (HbA1c), percent to HbA1c goal, and adverse events (AEs). Change from baseline in HbA1c, change from baseline in weight and hypoglycemia were analyzed by Hispanic/Latino and non-Hispanic/Latino subgroups for each study. RESULTS: Of the 3,136 patients randomized to dulaglutide 1.5 or 0.75 mg, 949 were reported as having Hispanic/Latino ethnicity. Baseline characteristics were similar for Hispanic/Latino and overall populations, except there were slightly more Hispanic/Latino females and weight was slightly lower for Hispanic/Latino patients. Hispanic/Latino patients receivingdulaglutide 1.5 mg had a reduction in HbA1c of 1.25% (95% confidence interval [CI]: -1.35, -1.15); dulaglutide 0.75 mg had a reduction of 1.07% (95% CI: -1.18, -0.96). Reductions in HbA1c and percent to goal HbA1c <7% and ≤6.5% were similar between Hispanic/Latino patients and the overall population. Weight change and hypoglycemia were similar between Hispanic/Latino and non-Hispanic/Latino subgroups for all studies. Treatment-emergent AEs were consistent with the overall population. CONCLUSION:Dulaglutide improved glycemic control with the potential for weight loss in Hispanic/Latino patients with T2D. Dulaglutide was well tolerated and had a low risk of hypoglycemia when used without insulin secretagogues or insulin. In the Hispanic/Latino population, dulaglutide efficacy and safety was consistent with that of the overall population. ABBREVIATIONS: AE = adverse event AWARD = Assessment of Weekly AdministRation of dulaglutide in Diabetes BID = twice daily CARMELA = The Cardiovascular Risk Factor Multiple Evaluation of Latin America CI = confidence interval GLP-1 RA = glucagon-like peptide-1 receptor agonist HbA1c = glycosylated hemoglobin T2D = type 2 diabetes.
RCT Entities:
OBJECTIVE: The aim of this post hoc analysis was to assess the efficacy and safety of once-weekly dulaglutide in Hispanic/Latino patients with type 2 diabetes (T2D) in phase 3 AWARD trials 1 to 6. METHODS: Hispanic/Latino data at Week 26 were pooled across studies for each dulaglutide dose to analyze the change from baseline in glycosylated hemoglobin (HbA1c), percent to HbA1c goal, and adverse events (AEs). Change from baseline in HbA1c, change from baseline in weight and hypoglycemia were analyzed by Hispanic/Latino and non-Hispanic/Latino subgroups for each study. RESULTS: Of the 3,136 patients randomized to dulaglutide 1.5 or 0.75 mg, 949 were reported as having Hispanic/Latino ethnicity. Baseline characteristics were similar for Hispanic/Latino and overall populations, except there were slightly more Hispanic/Latino females and weight was slightly lower for Hispanic/Latino patients. Hispanic/Latino patients receiving dulaglutide 1.5 mg had a reduction in HbA1c of 1.25% (95% confidence interval [CI]: -1.35, -1.15); dulaglutide 0.75 mg had a reduction of 1.07% (95% CI: -1.18, -0.96). Reductions in HbA1c and percent to goal HbA1c <7% and ≤6.5% were similar between Hispanic/Latino patients and the overall population. Weight change and hypoglycemia were similar between Hispanic/Latino and non-Hispanic/Latino subgroups for all studies. Treatment-emergent AEs were consistent with the overall population. CONCLUSION: Dulaglutide improved glycemic control with the potential for weight loss in Hispanic/Latino patients with T2D. Dulaglutide was well tolerated and had a low risk of hypoglycemia when used without insulin secretagogues or insulin. In the Hispanic/Latino population, dulaglutide efficacy and safety was consistent with that of the overall population. ABBREVIATIONS: AE = adverse event AWARD = Assessment of Weekly AdministRation of dulaglutide in Diabetes BID = twice daily CARMELA = The Cardiovascular Risk Factor Multiple Evaluation of Latin America CI = confidence interval GLP-1 RA = glucagon-like peptide-1 receptor agonist HbA1c = glycosylated hemoglobin T2D = type 2 diabetes.
Authors: Chantal Mathieu; Stefano Del Prato; Fady T Botros; Vivian T Thieu; Imre Pavo; Nan Jia; Axel Haupt; Chrisanthi A Karanikas; Luis-Emilio García-Pérez Journal: Diabetes Obes Metab Date: 2018-05-02 Impact factor: 6.577