SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) was a randomized, double-blind, placebo-controlled trial of 16,492 adult patients with type 2 diabetes, designed to minimize glycemic control differences between Onglyza and placebo by allowing study physicians to actively manage blood glucose through use of additional antidiabetic drugs or dose titration.
In the hypoglycemia assessment, patients were analyzed by antidiabetic medication at baseline (not treated with antidiabetic drugs, treated with metformin alone, treated with sulfonylurea, treated with insulin alone or treated with insulin in combination with other antidiabetic drugs) and HbA1c at baseline.
Results demonstrated no increased rate of hypoglycemia among patients treated with Onglyza compared to placebo when added to metformin monotherapy (2.4 events per 100 patient years for Onglyza vs. 2.6 for placebo; HR: 0.92).
Higher rates of hypoglycemia were noted only in the Onglyza group compared to the placebo group among patients taking sulfonylureas at baseline, regardless of HbA1c (9.7 events per 100 patient years for Onglyza vs. 6.8 for placebo; HR: 1.42). Additionally, a greater percentage of patients taking Onglyza reached their target HbA1c without hypoglycemia, except patients who were treated with sulfonylureas alone at baseline.
Results from SAVOR found rates of any events of adjudication-confirmed pancreatitis were balanced between the Onglyza and placebo treatment groups; 24 patients in the Onglyza arm vs. 21 patients in the placebo arm.
In patients who experienced pancreatitis, the duration of the event, study drug actions and outcome of the adverse event were balanced across the two treatment arms. Observed rates of pancreatic cancer in patients were also low; five in the Onglyza arm vs. 12 patients in the placebo arm.
Onglyza is a competitive DPP4 inhibitor that slows the inactivation of incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.