In a pooled analysis, patients treated with dulaglutide 1.5 mg showed an average reduction in of -1.26% for men and -1.33% for women after 6 months.
Dulaglutide treatment produced consistent reductions in HbA1c across different gender groups and varying durations of diabetes.
Patients with a higher baseline HbA1c (≥8.5%) experienced greater reductions in HbA1c compared to those with lower levels (<8.5%).
Similar trends in reductions were observed in line with HbA1c changes.
Body weight changes were generally comparable across different durations of diabetes and baseline HbA1c subgroups, with women experiencing slightly more favorable outcomes.
The incidence and rate of hypoglycaemia were lower in patients with higher baseline HbA1c, although results varied in one specific study involving mealtime insulin.
Simplified
AIMS: To evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in patients with type 2 diabetes by subgroups of gender, duration of diabetes and baseline (HbA1c) in the dulaglutide clinical development programme (AWARD-1 to -6 and -8 clinical trials).
METHODS: Change in HbA1c was analysed by gender, duration of diabetes (<5, ≥5 years and <10, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia and gastrointestinal adverse events were evaluated for individual trials.
RESULTS: In the pooled analysis of patients treated with dulaglutide 1.5 mg at 6 months, the reductions in HbA1c from baseline were similar across gender (men: least squares [LS] mean -1.26% [95% confidence interval {CI} -1.36, -1.16]; women: LS mean -1.33% [95% CI -1.43, -1.24]) and among duration of diabetes subgroups (<5 years: LS mean -1.32% [95% CI -1.43, -1.22]; ≥5 and <10 years: LS mean -1.33% [95% CI -1.43, -1.22]; ≥10 years: -1.24% [95% CI -1.35, -1.14]). Patients with baseline HbA1c ≥8.5% had greater HbA1c reductions than patients with baseline HbA1c <8.5%, (≥8.5%: LS mean -1.86% [95% CI -1.97, -1.75]; <8.5%: LS mean -1.02% [95% CI -1.12, -0.93]). Reductions in (FBG) were consistent with HbA1c changes. Similar results were observed with dulaglutide 0.75 mg. In general, body weight changes were similar among duration of diabetes and in baseline HbA1c subgroups, respectively; women had a numerically greater weight loss or less weight gain than men with both dulaglutide doses. There was no clinically meaningful difference in hypoglycaemia trends by gender or duration of diabetes. Hypoglycaemia incidence and rate were generally lower in patients with baseline HbA1c ≥8.5% than in those with <8.5%, except for the AWARD-4 study (combination with mealtime insulin).
CONCLUSIONS: Across the AWARD studies, dulaglutide demonstrated significant improvements in glycaemic control irrespective of gender, duration of diabetes, or baseline HbA1c, with greater HbA1c and FBG reductions in patients with a higher baseline HbA1c. Dulaglutide was well tolerated, with a safety profile similar to other glucagon-like peptide-1 receptor agonists.
Key numbers
-1.26%
Reduction (Dulaglutide 1.5 mg)
LS mean reduction at 6 months for men receiving dulaglutide 1.5 mg.
-1.86%
Reduction (Dulaglutide 1.5 mg)
LS mean reduction at 6 months for patients with baseline ≥8.5%.
5470
Total Patients Analyzed
Total number of patients across seven phase III studies.
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F. G. is now carrying out clinical trials as co‐investigator for Eli Lilly and Sanofi, providing advisory services to Eli Lilly, Sanofi, Takeda, AstraZeneca, and Lifescan, and receiving grant support from Takeda, Eli Lilly, and Lifescan. B. G. has received honoraria for participating in advisory boards from: Amgen, AstraZeneca, Boehringer Ingelheim, Lilly, Merck, Novo Nordisk and has received honoraria for lectures from these companies as well as from Bristol Myers Squibb and Novartis. S. D.‐J. is principal Investigator/Co‐investigator for Clinical Trials Contracts to University of Tennessee, AstraZeneca, Novo Nordisk, Boehringer Ingelheim, and consultant/advisory board member of Amgen, Merck, Sanofi, AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Janssen, Response Scientific, Inc. V. T., I. P., M. Y., N. Z. and L. E. G. P. are employees and stock holders of Eli Lilly and Company. K. E. R. is an employee of Eli Lilly and Company.
