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
What is the feasibility of setting and achieving individualized targets over 24 weeks, along with conventional glycosylated hemoglobin (HbA1c) reduction, using vildagliptin compared to placebo?
A multinational, double-blind, 24-week study was conducted in drug-naive or inadequately controlled (HbA1c ≥7.0% to ≤10.0%) patients with type 2 diabetes ages 70 years or older from 45 outpatient centers in Europe. Investigators set individualized treatment targets on the basis of age, baseline HbA1c, 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. Co-primary efficacy endpoints were proportion of patients reaching their investigator-defined HbA1c target and HbA1c reduction from baseline to study end.
A total of 139 patients were randomly assigned to the vildagliptin and placebo groups: 37 (27%) of 137 patients in the placebo group achieved their individualized 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; p < 0.0001). This finding was accompanied by a clinically relevant 0.9% reduction in HbA1c from a baseline of 7.9% with vildagliptin and a between-group difference of –0.6%, p < 0.0001). The overall safety and tolerability was similar in the vildagliptin and placebo groups, with low incidence of hypoglycemia and no emergence of new safety signals.
This study is the first to introduce and show the feasibility of using individualized HbA1c targets as an endpoint in any type 2 diabetes population. Individualized glycemic target levels are achievable with vildagliptin without any tolerability issues in the elderly type 2 diabetes population.
More than one half of elderly patients with type 2 diabetes do not achieve conventionally recommended goals of glycemic control (HbA1c <7%). Guidelines for elderly diabetics have included individualized treatment targets of glycemic control despite the absence of efficacy and safety from trial data in persons over 70 years. This study demonstrated that the selective dipeptidyl peptidase 4 (DPP4) is safe and effective in elderly patients with type 2 diabetes and can be used for individualized glycemic targets.
Keywords: Incidence, Hemoglobin A, Blood Glucose, Nitriles, Europe, Diabetes Mellitus
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