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. 2020 Aug;11(8):1835-1847.
doi: 10.1007/s13300-020-00866-2. Epub 2020 Jul 8.

Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study

Ides M Colin  1 , Kathy Alexandre  2 , Jacques Bruhwyler  3 , André Scheen  4 , Ann Verhaegen  5
Affiliations

Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study

Ides M Colin et al. Diabetes Ther. 2020 Aug.

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.

Keywords: Basal-bolus insulin regimen; Hypoglycemia; Insulin glargine 300 U/mL; Quality of life; Type 2 diabetes.

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Figures

Fig. 1
Fig. 1
Participant disposition in MAGE. AE adverse event, ITT intent-to-treat, PP per-protocol, T1DM type 1 diabetes
See this image and copyright information in PMC

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