Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial
An erratum to this article was published (Lancet Diabetes Endocrinol, Nov 2023 ↗)
Primary result · Incidence rate of diabetesResult — go to the resultHazard ratio 0.83 95% CI 0.70–0.99Authors' conclusion
Metformin plus lifestyle intervention further reduced the risk of developing diabetes than lifestyle intervention alone in Chinese people with impaired glucose regulation, showing additional benefits of combined intervention in preventing progression to diabetes without new safety concerns.
Study context
- Population
- Chinese adults aged 18–70 years with impaired glucose regulation (impaired glucose tolerance or impaired fasting glucose, or both), BMI 21–32 kg/m²; 43 endocrinology departments across Chinarandomized 1:1
- Participants
- 1,678 adults
- Comparison
- Metformin plus lifestyle intervention vs lifestyle intervention alone
- Metformin + lifestylen = 831
- Lifestyle alonen = 847reference
- Primary endpoint
- Incidence of newly diagnosed diabetes
- Follow-up
- end of 2-year follow-up
Methodological detailsmulticentre, open-label, block randomisation (1:1)
- Multicentre
- Open-label
- Block randomisation (1:1)
Primary result
Incidence rate of diabetes · median follow-up 2.03 years
Hazard ratio
0.83
95% CI 0.70–0.99
log-rank p=0.043
By group
Metformin + lifestyle
17.27 per 100 person-years
95% CI 15.19–19.56
Lifestyle alone
19.83 per 100 person-years
CI 17.67–22.18
As reported in the abstract
Safety
Adverse events
- Higher proportion with AEs in metformin + lifestyle vs lifestyle alone, primarily more gastrointestinal AEs
- Serious AEs similar in both groups
Original publication
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