Post-trial monitoring of a randomised controlled trial of intensive glycaemic control in type 2 diabetes extended from 10 years to 24 years (UKPDS 91)
Authors' conclusion
Early intensive glycaemic control with sulfonylurea or insulin, or with metformin, compared with conventional glycaemic control, appears to confer a near-lifelong reduced risk of death and myocardial infarction. Achieving near normoglycaemia immediately following diagnosis might be essential to minimise the lifetime risk of diabetes-related complications to the greatest extent possible.
Study context
- Population
- Surviving UKPDS participants with newly diagnosed T2D at the end of the 10-year post-trial monitoring period, linked to National Health Service (NHS) data; mean age at baseline 50.2 years (SD 8.0), 41.3% female1,489 linked to NHS data
- Participants
- 1,525 participants
- Comparison
- Early intensive glycaemic control vs conventional glycaemic control
- Primary endpoint
- Seven prespecified aggregate clinical outcomes: any diabetes-related endpoint, diabetes-related death, death from any cause, MI, stroke, peripheral vascular disease, microvascular disease
- Follow-up
- Up to 24 years after trial end
Methodological detailsextended follow-up via routinely collected NHS data, seven prespecified aggregate clinical outcomes, Kaplan-Meier time-to-event and log-rank analyses, Follow-up from baseline 0 to 42 years, median 17.5 years (IQR 12.3-26.8); overall follow-up increased by 21%, from 66 972 to 80 724 person-years
- Extended follow-up via routinely collected NHS data
- Seven prespecified aggregate clinical outcomes
- Kaplan-Meier time-to-event and log-rank analyses
- Follow-up from baseline 0 to 42 years, median 17.5 years (IQR 12.3-26.8); overall follow-up increased by 21%, from 66 972 to 80 724 person-years
Primary result
As reported in the abstract
Overall relative risk reductions vs conventional glycaemic control
- SU or insulin · absolute risk reduction 2.7%
- relative risk reduction, death from any cause 10% (95% CI 2–17); P = 0.015
- SU or insulin · absolute risk reduction 3.3%
- relative risk reduction, MI 17% (95% CI 6–26); P = 0.002
- SU or insulin · absolute risk reduction 3.5%
- relative risk reduction, microvascular disease 26% (95% CI 14–36); P < 0.0001
- Metformin · absolute risk reduction 4.9%
- relative risk reduction, death from any cause 20% (95% CI 5–32); P = 0.010
- Metformin · absolute risk reduction 6.2%
- relative risk reduction, MI 31% (95% CI 12–46); P = 0.003
Original publication
Post-trial monitoring of a randomised controlled trial of intensive glycaemic control in type 2 diabetes extended from 10 years to 24 years (UKPDS 91). Lancet. Published 18 May 2024. doi:10.
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