Research Paper Volume 9, Issue 3 pp 769—777
Individualizing treatment targets for elderly patients with type 2 diabetes: factors influencing clinical decision making in the 24-week, randomized INTERVAL study
- 1 Diabetes and Vascular Research Centre, University of Exeter Medical School, Exeter EX2 5AX, UK
- 2 Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA
- 3 Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland
received: November 8, 2016 ; accepted: February 19, 2017 ; published: March 5, 2017 ;https://doi.org/10.18632/aging.101188
How to Cite
We tested the feasibility of setting individualized glycemic goals and factors influencing targets set in a clinical trial in elderly patients with type 2 diabetes.
A 24-week, randomized, double-blind, placebo-controlled study was conducted in 45 outpatient centers in seven European countries. 278 drug-naïve or inadequately controlled (mean HbA1c 7.9%) patients with type 2 diabetes aged ≥70 years with HbA1c levels ≥7.0% and ≤10.0% were enrolled. Investigator-defined individualized HbA1c targets and the impact of baseline characteristics on individualized treatment targets was evaluated.
The average individualized HbA1c target was set at 7.0%. HbA1c at baseline predicted a target setting such that higher the HbA1c, more aggressive was the target (P<0.001). Men were more likely to be set aggressive targets than women (P=0.026). Frailty status of patients showed a trend towards significance (P=0.068), whereas diabetes duration, age, or polypharmacy did not. There was heterogeneity between countries regarding how baseline factors were viewed.
Despite training and guidance to individualize HbA1c goals, targets were still set in line with conventional values. A strong influence of country-specific guidelines on target setting was observed; confirming the importance of further education to implement new international guidelines in older adults.
FAS: full analysis set; HbA1c: glycated hemoglobin; INTERVAL: INdividualized Treatment targets for EldeRly patients with type 2 diabetes using Vildagliptin Add-on or Lone therapy.