Background: The efficacy and safety of switching to Gla-300 in T2DM uncontrolled on BI has been demonstrated in RCTs and RWE studies in the US and EU. However, similar data in wider geographic regions are limited. ARTEMIS-DM is a multicentre, interventional, single-arm, Phase IV study aimed to evaluate the impact of this switch in 14 countries across Asia, Middle East - Africa and Latin America.
Methods: ARTEMIS-DM study enrolled participants with HbA1c between 7.5 and 10%. Primary endpoint was change in HbA1c from baseline to 26 weeks.
Results: Of 372 participants (50% male), the mean (SD) age was 60.9 (10.0) years and BMI was 29.57 (5.43) kg/m2. Majority of participants (62.6%) were <65 years and median diabetes duration was 12 years. A total of 222 (59.7%) participants had insulin glargine (100 U/mL) as previous BI. There was a decrease in mean HbA1c and fasting plasma glucose (FPG) at Weeks 12 and 26 (Table). Any hypoglycemic event occurred in 20.4% of the people with 1 (0.3%) event of severe hypoglycemia and 9.4% of people experienced nocturnal hypoglycemia. With a recommended titration algorithm, the mean dose increased from 0.35 U/kg at baseline to 0.5 U/kg at Week 26.
Conclusion: In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration was associated with improved glycemic control and low incidence of hypoglycemia.
B. Sethi: None. K. Alrubeaan: None. M. Unubol: None. M. N. Mabunay: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. B. Berthou: None. V. Pilorget: Employee; Self; Sanofi. G. Frechtel: None.