Introduction & Objective: The UVLab platform - equipped with a metabolic model and 6062 virtual subjects (VS) with type 2 diabetes (T2D) - describes T2D heterogeneity. This work evaluates UVLab's ability to replicate the findings from a 26-week phase 3 clinical trial (NCT01336023) comparing degludec (IDeg), liraglutaide (Lira), and a fixed-ratio combination of the two (IDegLira).

Methods: IDeg, Lira, and IDegLira were administered to the VS according to clinical trial protocol. Subpopulations matching early trial glycemic metrics were selected; later data were not used to inform the simulations. Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), daily drug dose, and hypoglycemia events (HE) over the 26-week study were compared between clinical trial and simulations.

Results: Subpopulations of 208, 283, and 417 VS for the IDeg, Lira, and IDegLira arm, respectively, were selected using a method matching mean and standard deviation of HbA1c, FPG, and HE from trial baseline, week-4, and week-8 (IDegLira only) data. Figure 1 shows the evolution of glycemic metrics, comparing clinical trial and simulations. Overall median absolute relative error across all metrics and arms was 2.6% [0.6-11%].

Conclusion: UVLab effectively replicates trial outcomes, affirming its predictive capability for T2D treatment. This endorses in-silico models for treatment planning and enhancement of clinical trials.

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Disclosure

M. Ganjiarjenaki: None. C. Fabris: Research Support; Novo Nordisk A/S. Other Relationship; Novo Nordisk A/S, Dexcom, Inc. A. El Fathi: None. D. Lv: None. B. Kovatchev: Research Support; Dexcom, Inc., Novo Nordisk, Tandem Diabetes Care, Inc. Other Relationship; Dexcom, Inc., Johnson & Johnson Medical Devices Companies, Novo Nordisk, Sanofi. M.D. Breton: Consultant; Dexcom, Inc. Research Support; Dexcom, Inc. Speaker's Bureau; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc., Novo Nordisk. Speaker's Bureau; Vertex Pharmaceuticals Incorporated. Consultant; PhysioLogic Devices. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi.

© 2024 by the American Diabetes Association
2024
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