The 28-week, prospective, multicenter, open-label OPTIMIZE study, conducted in Belgium (presented at ADA 2018) and Canada, evaluated treatment optimization with once-daily (OD) Gla-300 in combination with a prandial insulin analog in adults with T1DM previously uncontrolled (HbA1c 8-10%) on twice-daily (BID) BI as part of basal-bolus therapy.
The intent-to-treat and safety populations comprised 94 patients (53.2% women; 51.1% from Belgium); mean (SD) age 49.4 (13.1) years and BMI 27.8 (4.7) kg/m². Prior to the study, 45.7% received insulin glargine 100 U/mL and 52.1% insulin detemir. There was a statistically significant reduction in HbA1c from baseline to month 6 (p<0.0001; Table). A statistically significant increase in BI dose (p=0.032) was observed, but there were no significant changes in prandial insulin dose. Hypoglycemic event rates did not significantly change (Table). Statistically significant improvements were seen in the Diabetes Treatment Satisfaction Questionnaire total and perceived hyperglycemia scores, and patient satisfaction score for number of injections (p<0.0001).
In this clinically challenging population, better overall treatment satisfaction and improvement in HbA1c, without increase in the rate of hypoglycemia, was achieved on switching from BID to OD Gla-300 plus prandial insulin.
C. Mathieu: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; AstraZeneca, Novartis AG, Novo Nordisk A/S, Sanofi. P. Stella: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Bruhwyler: Other Relationship; Self; Sanofi. K.C. Alexandre: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi.
Sanofi (EudraCT 2015-001186-46)
