Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study

Background Guidelines suggest setting individualised targets for glycaemic control in elderly patients with type 2 diabetes, despite no evidence. We aimed to assess the feasibility of setting and achieving individualised targets over 24 weeks along with conventional HbA(1c) reduction using vildagliptin versus placebo. Methods In this multinational, double-blind, 24 week study, we enrolled drug-naive or inadequately controlled (glycosylated haemoglobin A(1c) [HbA(1c)] >= 7.0% to <= 10.0%) patients with type 2 diabetes aged 70 years or older from 45 outpatient centres in Europe. Investigators set individualised treatment targets on the basis of age, baseline HbA(1c), comorbidities, and frailty status before a validated automated system randomly assigned patients (1: 1) to vildagliptin (50 mg once or twice daily as per label) or placebo. Coprimary efficacy endpoints were proportion of patients reaching their investigator-defined HbA(1c) target and HbA(1c) reduction from baseline to study end. The study is registered with ClinicalTrials.gov, number NCT01257451, and European Union Drug Regulating Authorities Clinical Trials database, number 2010-022658-18. Findings Between Dec 22, 2010, and March 14, 2012, we randomly assigned 139 patients each to the vildagliptin and placebo groups. 37 (27%) of 137 patients in the placebo group achieved their individualised targets by education and interactions with the study team alone and 72 (52.6%) of 137 patients achieved their target in the vildagliptin group (adjusted odds ratio 3.16, 96.2% CI 1.81-5.52; p<0.0001). This finding was accompanied by a clinically relevant 0.9% reduction in HbA(1c) from a baseline of 7.9% with vildagliptin and a between-group difference of -0.6% (98.8% CI -0.81 to -0.33; p<0.0001). The overall safety and tolerability was similar in the vildagliptin and placebo groups, with low incidence of hypoglycaemia and no emergence of new safety signals. Interpretation This study is the first to introduce and show the feasibility of using individualised HbA(1c) targets as an endpoint in any type 2 diabetes population. Individualised glycaemic target levels are achievable with vildagliptin without any tolerability issues in the elderly type 2 diabetes population.