Type 2 & other diabetes

Safety and effectiveness of dulaglutide in Chinese adults with type 2 diabetes mellitus in a real‐world setting: A prospective, observational post‐marketing study

Diabetes Obes MetabPublished Prospective observational post-marketing study

Authors' conclusion

Dulaglutide showed a safety profile consistent with previous reports and significantly reduced HbA1c in a real-world setting. These findings support the clinical use of dulaglutide and inform the individualized treatment of patients with T2DM in China.

Study context

Population
Adults with T2DM prescribed dulaglutide in routine clinical practice, 46 hospitals in Chinasafety analysis set
Participants
3,291 adults
Outcome
Incidence of TEAEs and serious AEs in patients who received ≥1 dose of dulaglutide
Follow-up
Up to 24 weeks
Methodological detailsreal-world, multicentre (46 hospitals in China), 20 January 2020 to 24 November 2021
  • Real-world
  • Multicentre (46 hospitals in China)
  • 20 January 2020 to 24 November 2021

Main finding

As reported in the abstract

Treatment-emergent adverse events (TEAEs)
1333 (40.5%)
Nausea
n = 193, 5.9%
Diarrhoea
n = 183, 5.6%
Decreased appetite
n = 179, 5.4%
Serious AEs
160 (4.9%)
TEAEs leading to treatment discontinuation
212 (6.4%)

Observational data: associations, not effects.

Further findings

Mean absolute change in HbA1c (exploratory) · baseline to week 24

Mean absolute change in HbA1c
−1.65% (p < .001)

HbA1c reduction by subgroup (post hoc) · week 24

Greater reduction with T2DM duration ≤5 years
P = 0.002
Greater reduction with baseline HbA1c ≥8.5%
P < 0.001
Greater reduction without atherosclerotic CVD
P = 0.002

Mean absolute change in body weight (exploratory) · baseline to week 24

Mean absolute change in body weight
−2.62 kg (p < .001)

Safety

Adverse events · up to 24 weeks

TEAEs
1333 (40.5%)
Serious AEs
160 (4.9%)
Discontinuation due to TEAEs
212 (6.4%)

Original publication

Safety and effectiveness of dulaglutide in Chinese adults with type 2 diabetes mellitus in a real‐world setting: A prospective, observational post‐marketing study. Diabetes Obes Metab. Published 23 August 2023. doi:10.1111/dom.15252

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