Results of the Novartis-sponsored INTERVAL study have demonstrated the feasibility of setting and achieving individualized treatment targets in elderly patients with type 2 diabetes treated with Novartis drug, Galvus (vildagliptin). In previous large-scale studies, which used aggressive, identical HbA1c targets for all patients with type 2 diabetes, elderly patients failed to reach treatment goals.
Current treatment guidelines recommend individualized goals in elderly patients based on characteristics such as age, comorbidities and frailty; however, no studies using individual targets have previously been conducted.
The INTERVAL study introduced the unique endpoint of investigator-defined individualized HbA1c targets, reflecting guidance in current guidelines. In the study, elderly patients with type 2 diabetes who were treated with Galvus (vildagliptin) achieved greater reductions in HbA1c and were three times more likely to reach individualized treatment goals without major tolerability issues than those treated with placebo on top of background oral antidiabetic treatment.
In the 24-week INTERVAL study, 52.6 percent of patients treated with vildagliptin achieved unique, investigator-identified individualized treatment goals compared to 27 percent of patients treated with placebo (adjusted odds ratio 3.16, 96.2% CI 1.81 to 5.52; p<0.0001). Patients treated with vildagliptin also achieved clinically relevant reductions in HbA1c of 0.9% from a baseline compared to a 0.3% reduction from a baseline in those treated with placebo, a difference of 0.6% (98.8% CI -0.81 to -0.33; p<0.0001). Average baseline HbA1c values for both groups were 7.9%. The overall safety and tolerability profile was similar in the vildagliptin and placebo groups, with a low incidence of hypoglycemia, no reported cases of pancreatitis or clinically significant hepatic-related events, and no new safety signals.
Results from the INTERVAL study were published in the Lancet