Safety and effectiveness of dulaglutide in Chinese adults with type 2 diabetes mellitus in a real‐world setting: A 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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