Jean-François Yale1, Lori Berard2, Mélanie Groleau3, Pasha Javadi3, John Stewart3, Stewart B Harris4. 1. Department of Medicine, McGill University, Montreal, Quebec, Canada. 2. Winnipeg Regional Health Authority, Health Sciences Centre, Winnipeg Diabetes Research Group, Winnipeg, Manitoba, Canada. 3. Sanofi Canada, Medical Affairs, Montreal, Quebec, Canada. 4. Department of Family Medicine, Western University, London, Ontario, Canada. Electronic address: Stewart.Harris@schulich.uwo.ca.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulinglargine 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Sunil M Jain; Krishna Seshadri; A G Unnikrishnan; Manoj Chawla; Pramila Kalra; V P Vipin; E Ravishankar; Jay Chordia; Sambit Das; Jasjeet Wasir; S M Bandookwala; Neelakshi Deka; Ghanshyam Agarwal; G Vijaykumar; Suhas Erande Journal: Diabetes Ther Date: 2020-02-03 Impact factor: 2.945
Authors: Lori Berard; Noreen Antonishyn; Kathryn Arcudi; Sarah Blunden; Alice Cheng; Ronald Goldenberg; Stewart Harris; Shelley Jones; Upender Mehan; James Morrell; Robert Roscoe; Rick Siemens; Michael Vallis; Jean-François Yale Journal: Diabetes Ther Date: 2018-02-23 Impact factor: 2.945