Association of Baseline Factors With Glycemic Outcomes in GRADE: A Comparative Effectiveness Randomized Clinical Trial
Authors' conclusion
Several baseline factors were associated with the glycemic outcome but not with differential effectiveness of the four medications. Failure to maintain HbA1c <7% was largely driven by younger age and higher HbA1c at baseline. Factors that predict earlier glycemic deterioration could help in targeting patients for more aggressive management.
Study context
- Population
- T2D diagnosed <10 years, on metformin, HbA1c 6.8–8.5%
- Participants
- 5,047 participants
- Comparison
- Glargine vs glimepiride vs liraglutide vs sitagliptin, added to metformin; association of baseline factors with glycemic outcome
- Primary endpoint
- Glycemic outcome: HbA1c ≥7.0%, subsequently confirmed
- Follow-up
- Years 1 and 4
Methodological detailscomparative effectiveness, univariate and multivariate regression, classification and regression tree (CART) analyses
- Comparative effectiveness
- Univariate and multivariate regression
- Classification and regression tree (CART) analyses
Primary result
As reported in the abstract
Baseline factors associated with glycemic outcome · years 1 and/or 4
- Univariate: younger age (<58 years), Hispanic ethnicity, higher HbA1c, fasting glucose and TG, lower insulin secretion and relatively greater insulin resistance associated with the glycemic outcome at years 1 and/or 4
- No factors associated with differential effectiveness of the medications by year 4
- Multivariate: treatment group, younger age, higher baseline HbA1c and fasting glucose jointly associated with the glycemic outcome by year 4
- Superiority of glargine and liraglutide at year 4 persisted after control for multiple baseline factors
- CART: failure to maintain HbA1c <7% by year 4 more likely for younger participants and those with baseline HbA1c ≥7.4%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Association of Baseline Factors With Glycemic Outcomes in GRADE: A Comparative Effectiveness Randomized Clinical Trial. Diabetes Care. Published 29 January 2024. doi:10.
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