Visual Abstract

Insulin icodec* (icodec) is a once-weekly basal insulin in clinical development. In a phase 2 treat-to-target trial (NCT03922750) in patients with T2D switching from daily insulin (N=154), icodec with an initial 100% loading dose (LD; doubling the first dose) showed greater time in range (TIR, 70-180 mg/dL) vs. insulin glargine U100 (IGlar U100) at weeks 15 and 16 (primary endpoint), as measured by double-blinded Dexcom G6® CGM. This post hoc analysis compared TIR, time above range (TAR, >180 mg/dL) and below range (TBR, <70 and <54 mg/dL) for icodec (LD and no loading dose - NLD) vs. IGlar U100 throughout the 16-week period. Over the 16 weeks, overall observed mean TIRs were 71.4% for icodec LD, 60.7% for icodec NLD and 64.3% for IGlar U100. TBR<70 mg/dL and TBR<54 mg/dL remained below the recommended targets (<4% and <1%, respectively) in all groups over the 16 weeks. At weeks 15 and 16, proportion of patients achieving a combination of >70% TIR and <4% TBR<70 mg/dL were 64.2% for icodec LD, 40.0% for icodec NLD and 45.8% for IGlar U100. Icodec LD prevented a mild transient increase in TAR observed during the switch with icodec NLD and appeared to lead to a lower TAR than IGlar U100 over the 16 weeks. Overall, switching to icodec LD appeared to result in higher TIR and lower TAR than IGlar U100 through 16 weeks. TBR remained within the recommended targets. *Proposed INN.

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Disclosure

H. S. Bajaj: Other Relationship; Self; Eli Lilly and Company, Novo Nordisk, Research Support; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Kowa Pharmaceuticals America, Inc., Merck & Co., Inc., Sanofi, Tricida, Inc. R. Beck bang: Employee; Self; Novo Nordisk A/S. A. Gowda: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. M. M. Koefoed: Employee; Self; Novo Nordisk. P. A. Senior: Other Relationship; Self; Novo Nordisk, Vertex Pharmaceuticals Incorporated, Research Support; Self; Novo Nordisk. R. M. Bergenstal: Advisory Panel; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Onduo LLC., Roche , Sanofi, United Healthcare , Consultant; Self; Abbott Diabetes, Ascensia , Dexcom, Inc., Eli Lilly and Company, Hygieia, Johnson & Johnson, Medtronic, Novo Nordisk, Onduo LLC., Roche, Sanofi, United Healthcare, Other Relationship; Self; HealthPartners Institute, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Helmsley Charitable Trust, Hygieia, Johnson & Johnson, Medtronic, NIDDK, Novo Nordisk, Onduo LLC., Roche, Sanofi, United Healthcare.

© 2021 by the American Diabetes Association
2021
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