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Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter
Ides M Colin1, Kathy Alexandre2, Jacques Bruhwyler3
1Endocrino-Diabetology Clinical Research Unit, CHR Mons-Hainaut/Groupe Jolimont, Avenue Baudouin de Constantinople 5, 7000, Mons, Belgium. Ides.Michel.COLIN@jolimont.be.
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.
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