TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL

It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulin glargine 300 units/mL (GLA-300). The objective of this study was to compare safety and efficacy of 2 titration algorithms, INSIGHT and EDITION, for GLA-300 in people with uncontrolled type 2 diabetes mellitus, mainly in a primary care setting. This was a 12-week, open-label, randomized, multicentre pilot study. Participants were randomly assigned to 1 of 2 algorithms: they either increased their dosage by 1 unit/day (INSIGHT, n=108) or the dose was adjusted by the investigator at least once weekly, but no more often than every 3 days (EDITION, n=104). The target fasting self-monitored blood glucose was in the range of 4.4 to 5.6 mmol/L. The percentages of participants reaching the primary endpoint of fasting self-monitored blood glucose ≤5.6 mmol/L without nocturnal hypoglycemia were 19.4% (INSIGHT) and 18.3% (EDITION). At week 12, 26.9% (INSIGHT) and 28.8% (EDITION) of participants achieved a glycated hemoglobin value of ≤7%. No differences in the incidence of hypoglycemia of any category were noted between algorithms. Participants in both arms of the study were much more satisfied with their new treatment as assessed by the Diabetes Treatment Satisfaction Questionnaire. Most health-care professionals (86%) preferred the INSIGHT over the EDITION algorithm. The frequency of adverse events was similar between algorithms. A patient-driven titration algorithm of 1 unit/day with GLA-300 is effective and comparable to the previously tested EDITION algorithm and is preferred by health-care professionals. Il n'a pas pu être établi si l'utilisation d' un algorithme qui implique l'augmentation des doses d'insuline de 1 unité/jour peut causer plus d'hypoglycémie avec une insuline à action prolongée (insuline glargine 300 unités/mL; GLA-300). L'objectif de cette étude était de comparer l'innocuité et l'efficacité de 2 algorithmes de titration, INSIGHT et EDITION, utilisé avec GLA-300 chez les personnes dont le diabète sucré de type 2 n'était pas contrôllé, et ce, principalement dans des milieux de soins de santé de première ligne. Il s'agissait d'une étude clinique ouverte, multicentrique et à répartition aléatoire de 12 semaines. Les participants étaient répartis de manière aléatoire à l'un des 2 groupes : soit ils augmentaient leur dose de 1 unité/jour (algorithme INSIGHT, n=108), soit le chercheur ajustait la dose