Impact of Insulin Sensitivity and β-Cell Function Over Time on Glycemic Outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE): Differential Treatment Effects of Dual Therapy
Authors' conclusion
Insulin sensitivity and β-cell function affected treatment outcomes irrespective of drug assignment, with greater impact in the sitagliptin group on initial (short-term) HbA1c response in comparison with the glimepiride and liraglutide groups.
Study context
- Population
- GRADE participants on baseline metformin, followed mean ± SD 5.0 ± 1.3 years, HbA1c quarterly and OGTT at baseline, 1, 3 and 5 years
- Participants
- 1,254 / 1,262 / 1,268
- Comparison
- Glimepiride vs liraglutide vs sitagliptin added to metformin; association of insulin sensitivity and β-cell function with glycemic outcomes
- Glimepiriden = 1,254
- Liraglutiden = 1,262
- Sitagliptinn = 1,268
- Primary endpoint
- Glycemic failure: HbA1c ≥7% [53 mmol/mol]
Methodological detailscomparative effectiveness
- Comparative effectiveness
Primary result
As reported in the abstract
Glycemic failure (HbA1c ≥7%)
- Sitagliptin vs glimepiride and liraglutide: greater impact on risk of primary outcome, test of heterogeneity HOMA2-%S
- P = 0.005
- Sitagliptin vs glimepiride and liraglutide: impact on risk of primary outcome, heterogeneity early C-peptide (CP)
- P = 0.11
- Sitagliptin vs glimepiride and liraglutide: greater impact on risk of primary outcome, heterogeneity total CP
- P = 0.025
Secondary outcomes
Initial HbA1c lowering (3 months)
- Greater impact with sitagliptin vs glimepiride and liraglutide, heterogeneity HOMA2-%S
- P = 0.009
- Heterogeneity early CP
- P = 0.018
- Heterogeneity total CP
- P = 0.001
- Higher HOMA2-%S and greater CP responses associated with greater initial HbA1c lowering
Subsequent HbA1c rise
- Lesser impact with sitagliptin vs glimepiride and liraglutide, heterogeneity HOMA2-%S
- P = 0.175
- Heterogeneity early CP
- P = 0.006
- Heterogeneity total CP
- P < 0.001
- HOMA2-%S not associated with subsequent HbA1c rise; greater CP responses associated with slower rise
Secondary outcome: HbA1c >7.5% [58 mmol/mol]
- Higher HOMA2-%S and CP responses each associated with lower risk; no differential treatment effects
Original publication
Impact of Insulin Sensitivity and β-Cell Function Over Time on Glycemic Outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE): Differential Treatment Effects of Dual Therapy. Diabetes Care. Published 8 January 2024. doi:10.
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