Publications

BACKGROUND:
In the REWIND CV outcomes trial, the addition of dulaglutide 1.5 mg (DU) vs placebo (PL) to standard of care reduced the composite risk of CV death, nonfatal MI and nonfatal stroke in patients with type 2 diabetes and prior CV disease or CV risk factors. DU also reduced glycated hemoglobin (HbA1c) and weight (LSM difference -0.61% and -1.46 kg, respectively). This post hoc analysis assessed the effect of DU on HbA1c change when adjusting for the effects of key time-dependent and baseline characteristics and within-trial weight loss in the REWIND trial.

METHODS:
Change from baseline in HbA1c was assessed up to 72 months using MMRM models both unadjusted and adjusted for concomitant antihyperglycemic medication use, duration of diabetes, comorbidities (nephropathy and retinopathy) and BMI, individually, and by the degree of weight loss achieved.

RESULTS:
At all timepoints, a significant reduction in HbA1c from baseline was observed with DU independent of concomitant antihyperglycemic medication use, duration of diabetes, comorbidities, BMI and weight loss (p less than or equal to 0.005). An increase in HbA1c was generally observed with PL. HbA1c changes significantly differed between DU and PL at all timepoints (p less than or equal to 0.032). Similar HbA1c reductions were observed in the unadjusted analysis (p less than 0.001).

CONCLUSION:
DU treatment was associated with a durable decrease in HbA1c over 72 months, irrespective of concomitant antihyperglycemic medication use, duration of diabetes, comorbidities, BMI and weight loss.