Ides M Colin1, Kathy Alexandre2, Jacques Bruhwyler3, André Scheen4, Ann Verhaegen5. 1. Endocrino-Diabetology Clinical Research Unit, CHR Mons-Hainaut/Groupe Jolimont, Avenue Baudouin de Constantinople 5, 7000, Mons, Belgium. Ides.Michel.COLIN@jolimont.be. 2. Sanofi, Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19, 1831, Diegem, Belgium. 3. Lambda-Plus, Rue Camille Hubert 15, 5032, Gembloux, Belgium. 4. Division of Diabetes, Nutrition and Metabolic Disorders and Clinical Pharmacology Unit, CHU Liège, 4000, Liège, Belgium. 5. Department of Endocrinology, Diabetes and Metabolism, Antwerp University Hospital, 2650, Egedem/Antwerp, Belgium.
Abstract
INTRODUCTION: MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. MATERIALS AND METHODS: Participants were at least 18 years old, with T2DM for more than 1 year, HbA1c 7.0-10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA1c changes at months 3, 6, 9, and 12, and safety. RESULTS: MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p < 0.0001). The main reasons for Gla-300 initiation were to decrease HbA1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p < 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (p < 0.05). There were no statistically significant changes in HbA1c. Safety outcomes, including hypoglycemia, were comparable to previously reported trials. CONCLUSIONS: The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.
INTRODUCTION: MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulinGlargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. MATERIALS AND METHODS:Participants were at least 18 years old, with T2DM for more than 1 year, HbA1c 7.0-10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA1c changes at months 3, 6, 9, and 12, and safety. RESULTS: MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p < 0.0001). The main reasons for Gla-300 initiation were to decrease HbA1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p < 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (p < 0.05). There were no statistically significant changes in HbA1c. Safety outcomes, including hypoglycemia, were comparable to previously reported trials. CONCLUSIONS: The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.
Entities:
Keywords:
Basal-bolus insulin regimen; Hypoglycemia; Insulin glargine 300 U/mL; Quality of life; Type 2 diabetes
Authors: Ayman Abdullah Al Hayek; Asirvatham Alwin Robert; Abdulghani H Al Saeed; Mohamed Abdulaziz Al Dawish Journal: Clin Med Insights Endocrinol Diabetes Date: 2022-05-18