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

Colin, Ides M.; Alexandre, Kathy; Bruhwyler, Jacques; Scheen, André; Verhaegen, Ann

doi:10.1007/s13300-020-00866-2

Article (Scientific journals)

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

Colin, Ides M.; Alexandre, Kathy; Bruhwyler, Jacques et al.

2020 • In Diabetes Therapy, 11 (8), p. 1835-1847

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/249935

DOI
10.1007/s13300-020-00866-2

PubMed
32643130

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Keywords :

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

Abstract :

[en] 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, HbA(1c) 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, HbA(1c) 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 HbA(1c) (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 HbA(1c). 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.

Disciplines :

Endocrinology, metabolism & nutrition
Pharmacy, pharmacology & toxicology

Author, co-author :

Colin, Ides M.

Alexandre, Kathy

Bruhwyler, Jacques

Scheen, André ; Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques

Verhaegen, Ann

Language :

English

Title :

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

Publication date :

2020

Journal title :

Diabetes Therapy

ISSN :

1869-6953

eISSN :

1869-6961

Volume :

Issue :

Pages :

1835-1847

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 06 August 2020

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