Efficacy and Safety of Insulin Glargine 300 U/mL in People with Type 2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study

Bipin Sethi, Khalid Al-Rubeaan, Mustafa Unubol, Maria A Mabunay, Baptiste Berthou, Valerie Pilorget, Shireene R Vethakkan, Gustavo Frechtel, Bipin Sethi, Khalid Al-Rubeaan, Mustafa Unubol, Maria A Mabunay, Baptiste Berthou, Valerie Pilorget, Shireene R Vethakkan, Gustavo Frechtel

Abstract

Introduction: The efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.

Methods: The ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA1c] 7.5-10%) on BI were switched to Gla-300. The primary endpoint was change in HbA1c from baseline to 26 weeks. Key secondary endpoints were changes in HbA1c (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.

Results: A total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA1c 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA1c (- 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.

Conclusion: In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.

Gov identifier: NCT03760991.

Keywords: Basal insulin; Glycaemic control; Hypoglycaemia; Insulin glargine 300 U/mL; Type 2 diabetes mellitus.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Change in HbA1c from baseline to week 12 and 26. *Treatment effects are shown as LS mean (95% CI) change from baseline (MMRM model). Gla-300 insulin glargine 300 units/mL, HbA1c glycated haemoglobin, LS least squares, MMRM mixed-effect model with repeated measures, N number of evaluable participants, SD standard deviation
Fig. 2
Fig. 2
Change in A FPG, B Fasting SMPG, C 7-point SMPG and D BI dose from baseline to week 12 and 26. *Treatment effects are shown as LS mean (95% CI) change from baseline (MMRM model); analysis included N=354 for FPG and N=366 for fasting SMPG. BI basal insulin, FPG fasting plasma glucose, Gla-300 insulin glargine 300 units/mL, h hour, MMRM mixed-effect model with repeated measures, N number of evaluable participants, SD standard deviation, SMPG self-monitored plasma glucose

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Source: PubMed

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