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Emulating the Grade Trial Using Real-World Data

Speaker(s)

Deng Y1, Polley E2, Ross J3, Shah ND1, McCoy R1
1Mayo Clinic, Rochester, MN, USA, 2The University of Chicago, Chicago, IL, USA, 3Yale University, New Haven, CT, USA

OBJECTIVES

: To emulate the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) using real-world data prior to its publication.

METHODS

: We applied GRADE trial criteria to claims and laboratory data from OptumLabs Data Warehouse (OLDW) from 1/25/2010 to 6/30/2019. The study population was comprised of patients ≥30 years old with hemoglobin A1c (HbA1c) 6.5-8.5% on metformin monotherapy who started glimepiride, liraglutide, sitagliptin, or insulin glargine and met GRADE eligibility criteria. The primary outcome was time to HbA1c ≥7.0% and secondary outcomes were other metabolic, microvascular, macrovascular, and safety outcomes specified by GRADE. Propensity score (PS) weighting was used to emulate randomization of the groups, which were then compared using Kaplan-Meier estimate and Cox proportional hazards regression.

RESULTS

: We identified 8252 patients (19.7% of adults with diabetes who started the study drugs in OLDW) meeting GRADE eligibility criteria (glimepiride arm=4318, liraglutide arm=690, sitagliptin arm=2993, glargine arm=251). The glargine arm was excluded from analyses due to small sample size. Median times to primary metabolic failure were 364 (95% CI, 347-382) days for glimepiride, 741 (471-1171) days for liraglutide, and 342 (300-370) days for sitagliptin. Liraglutide was associated with lower risk of primary metabolic failure compared to glimepiride (HR 0.57 [0.43-0.77]) and sitagliptin (HR 0.56 [0.42-0.76]). Results were consistent for secondary metabolic failure (HbA1c ≥7.5% after reaching primary outcome). There were no significant differences among treatment groups for other secondary outcomes.

CONCLUSIONS

: In this emulation of the GRADE trial, liraglutide was significantly more effective at improving glycemic control than glimepiride or sitagliptin.

Code

CO32

Topic

Clinical Outcomes, Real World Data & Information Systems

Topic Subcategory

Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Reproducibility & Replicability

Disease

Drugs