Analysis of Long-term Follow-up of a Randomized Clinical Trial With Departures From Assigned Treatments: Estimation of Metformin Effects on Diabetes and Its Complications in the Diabetes Prevention Program Outcomes Study
Authors' conclusion
Elucidating metformin's long-term role in mitigating diabetes-related complications beyond its effects on diabetes prevention is challenging.
Study context
- Population
- High-risk adults in the DPP and its long-term follow-up DPPOS
- Comparison
- Metformin vs placebo
Methodological detailslong-term follow-up over 22 years, statistical methods accounting for departures from assigned treatment, intention-to-treat comparison, Departures from assigned metformin or placebo occurred mainly after diabetes developed (HbA1c ≥7.0%), managed by clinicians outside the study
- Long-term follow-up over 22 years
- Statistical methods accounting for departures from assigned treatment
- Intention-to-treat comparison
- Departures from assigned metformin or placebo occurred mainly after diabetes developed (HbA1c ≥7.0%), managed by clinicians outside the study
Primary result
As reported in the abstract
Diabetes incidence
- Metformin consistently reduced diabetes incidence across methods accounting for treatment deviations
Further findings
Diabetes complications and other outcomes after diabetes diagnosis
- All analytic methods gave similar metformin effect estimates, with 95% CIs for HRs including 1.0 for all outcomes except diabetes incidence; conclusions did not substantially change from the simpler ITT analysis
Original publication
Analysis of Long-term Follow-up of a Randomized Clinical Trial With Departures From Assigned Treatments: Estimation of Metformin Effects on Diabetes and Its Complications in the Diabetes Prevention Program Outcomes Study. Diabetes Care. Published 26 August 2025. doi:10.
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