Cohort 2. Age, years 41.0 (10.2) Diabetes duration, years 26.5 (15.8)
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1 Supplementary Table. Participant characteristics in cohort Cohort Number Sex, Male Female Age, years. (.) Diabetes duration, years.5 (5.) BMI, kg.m. (3.) HbA c, % mmol.mol. (.7) () C-peptide, nmol.l.3 (.) Basal insulin dose, U.kg.day.35 (.) Prandial insulin dose, U.kg.day.3 (.) Data are number of participants, or mean (standard deviation). American Diabetes Association. Published online at
2 Supplementary Table. Pharmacokinetic parameters in cohort after multiple doses in steady state Gla-. U.kg Cohort. U.kg Number INS-C max, µu.ml *. ±. 7. ±. INS-t /, h*. ± ±. INS-AUC, µu.h.ml * 3 ± 57 5 ± 3 INS-AUC 3, µu.h.ml * 3 ± 99 3 ± 7 T 5% -INS-AUC, h (9 ) ( ) T 5% -INS-AUC 3, h ( 3) (3 5) ΔINS, µu.ml, ( 9) (9 7) Swing,. (..)).7 (.5.) *Mean ± SD; median (interquartile range); INS-C maxss INS-C ss ; (INS-C maxss INS-C ss )/INS-C ss ; INS-C max = maximum serum insulin concentration; INS-t / = terminal half-life of serum insulin concentration; INS-AUC /3 = area under the concentration versus time curve from time to /3 hours. Supplementary Table 3. Pharmacodynamic parameters in cohort after multiple doses in steady state Cohort Gla-. U.kg. U.kg Number GIR-AUC, mg.kg * () 379 (35) GIR-AUC 3, mg.kg * 353 () 3 (573) GIR max, mg.kg.min 3. (3..) 3.7 ( ) T 5% -GIR-AUC, h ( ) ( ) T 5% -GIR-AUC 3, h ( 3) (3 5) *Mean ± SD; median (interquartile range); GIR-AUC /3 = glucose infusion rate from time to /3 hours; GIR max = maximum smoothed body weight standardized GIR (smoothing factor of.). American Diabetes Association. Published online at
3 Supplementary Table. Cumulative time of blood glucose control below thresholds after last administration on day Cohort Cohort Median time (h) BG (mg.dl ) Gla- Gla-. U.kg. U.kg. U.kg. U.kg * *Clamp level plus mg.dl ( mmol.l ). Note, data are right censored. BG, blood glucose. Supplementary Table 5. Last time of blood glucose below thresholds after last administration on day Median time (h) BG (mg.dl ) Cohort Cohort Gla- Gla-. U.kg. U.kg. U.kg. U.kg * *Clamp level plus mg.dl ( mmol.l ). Note, data are right censored. BG, blood glucose. American Diabetes Association. Published online at
4 Supplementary Figure. Steady-state study design Clamp Clamp Treatment Treatment Cohort (N=). U.kg -. U.kg - Gla-. U.kg - Gla-. U.kg -. U.kg - Cohort (N=). U.kg -. U.kg - Gla-. U.kg - Washout (5 9 days) Gla-. U.kg -. U.kg - Day Day Day Day American Diabetes Association. Published online at
5 Supplementary Figure. INS, GIR and BG profiles after multiple doses in steady state, overall and by participant (cohort ) Individual INS profiles (A), smoothed GIR profiles (B) and smoothed Biostator measured BG profiles (C) for participants in cohort (N=; Gla-. U.kg versus. U.kg ). Summary profiles of INS (D), smoothed GIR (E) and smoothed Biostator measured BG (F) are also provided. Raw data are shown as grey, filled circles. A LOESS smoothing factor of. was applied to all GIR and BG profiles. Summary INS profiles (D) overlay box-plots showing the dispersion of data at each time point: median, interquartile range (inner fences), outer fences and outside values. On INS profile plots, the lower limit of quantification (5. µu.ml ) is displayed for reference. INS, serum insulin concentration; GIR, body weight standardized glucose infusion rate; BG, blood glucose; LOESS, locally weighted regression in smoothing scatterplots. American Diabetes Association. Published online at
6 A Gla- INS [µu.ml - ] INS [µu.ml - ] INS [µu.ml - ] INS [µu.ml - ] B Gla- GIR [mg.kg -.min - ] GIR [mg.kg -.min - ] GIR [mg.kg -.min - ] GIR [mg.kg -.min - ] C Gla- BG [mg.dl - ] 5 5 BG [mg.dl - ] BG [mg.dl - ] 5 5 BG [mg.dl - ] D E F Gla- Gla- Gla- INS [µu.ml - ] GIR [mg.kg -.min - ] BG [mg.dl - ] American Diabetes Association. Published online at
7 Supplementary Figure 3. INS, GIR and BG profiles after multiple doses in steady state, overall and by participant (cohort ) Individual INS profiles (A), smoothed GIR profiles (B) and smoothed Biostator measured BG profiles (C) for participants in cohort (N=; Gla-. U.kg versus. U.kg ). Summary profiles of INS (D), smoothed GIR (E) and smoothed Biostator measured BG (F) are also provided. Raw data are shown as grey, filled circles. A LOESS smoothing factor of. was applied to all GIR and BG profiles. Summary INS profiles (D) overlay box-plots showing the dispersion of data at each time point: median, interquartile range (inner fences), outer fences and outside values. On INS profile plots, the lower limit of quantification (5. µu.ml ) is displayed for reference. INS, serum insulin concentration; GIR, body weight standardized glucose infusion rate; BG, blood glucose; LOESS, locally weighted regression in smoothing scatterplots. American Diabetes Association. Published online at
8 A Gla- INS [µu.ml - ] INS [µu.ml - ] INS [µu.ml - ] INS [µu.ml - ] B Gla- GIR [mg.kg -.min - ] GIR [mg.kg -.min - ] GIR [mg.kg -.min - ] GIR [mg.kg -.min - ] C Gla- BG [mg.dl - ] BG [mg.dl - ] BG [mg.dl - ] BG [mg.dl - ] D E F Gla- Gla- Gla- INS [µu.ml - ] GIR [mg.kg -.min - ] BG [mg.dl - ] American Diabetes Association. Published online at
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