Results of the INTERVAL study were published online in The Lancet today and for the first time demonstrated the feasibility of setting and achieving individualised treatment targets in elderly patients with type 2 diabetes.
Previous large-scale studies, which used aggressive, identical HbA1c targets for all patients with type 2 diabetes, raised questions due to failure of elderly patients to reach treatment goals and detrimental outcomes.[2,3] Accordingly, current treatment guidelines recommend individualised goals in elderly patients based on characteristics such as age, comorbidities and frailty; however, no studies using individual targets have previously been conducted.[1,4–6]
The INTERVAL study introduced the unique endpoint of investigator-defined individualised HbA1c targets, reflecting guidance in current guidelines,[1,4–6]. 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 individualised treatment goals without major tolerability issues than those treated with placebo on top of background oral antidiabetic treatment.
“Novartis is committed to supporting research that has the potential to advance the management of type 2 diabetes and provide new insights on ways to improve patient care,” said David Epstein, Division Head of Novartis Pharmaceuticals. “This first of its kind study shows the effectiveness of a patient-centric approach in the treatment of elderly patients with type 2 diabetes and demonstrates that individualised treatment targets are achievable with vildagliptin without tolerability issues.”
In the 24-week INTERVAL study, 52.6% of patients treated with vildagliptin achieved unique, investigator-identified individualised treatment goals compared to 27% 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 hypoglycaemia, no reported cases of pancreatitis or clinically significant hepatic-related events, and no new safety signals.
- Strain D et al. Individualised treatment targets for elderly patients with type 2 diabetes mellitus using vildagliptin add-on or lone therapy (INTERVAL): a 24-week, randomised, double-blind, placebo-controlled study. The Lancet, Early Online Publication, 23 May 2013. doi:10.1016/S0140-6736(13)60995-2. Last accessed 23 May 2013.
- Ginsberg A. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) Lipid Trial. Diabetes Care 2011.34;107-108.
- Patel A et al, for the ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-72.
- Kirkman MS et al. Diabetes in older adults. Diabetes Care 2012;35:2650-64.
- Inzucchi SE et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364-79.
- Sinclair AJ et al. European Diabetes Working Party for Older People 2011 clinical guidelines for type 2 diabetes mellitus: executive summary. Diabetes Metab 2011;37(3):S27-38.