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TABLE 1

Summary of Ultra-Rapid-Acting Insulin Randomized Controlled Trials (14,15,16,20,21)

TrialPatient DemographicsIntervention(s)A1C Outcome (ETD, %)PPG Outcome (ETD, mg/dL)
onset 1 (26 weeks) 
  • T1D; n = 1,143

  • Duration of diabetes: 20.9 ± 12.9 vs. 19.5 ± 12.1 vs. 19.3 ± 11.8 years

  • Baseline A1C: 7.6 ± 0.7 vs. 7.6 ± 0.7 vs. 7.6 ± 0.7%

  • Baseline FPG: 151.4 ± 55.8 vs. 145.6 ± 57.6 vs. 141.8 ± 50.2 mg/dL

 
Faster aspart mealtime (0–2 minutes before meals) vs. faster aspart postmeal (20 minutes after meals) vs. IAsp mealtime (0–2 minutes before meals) Faster aspart mealtime vs. IAsp: −0.15% (95% CI −0.23 to −0.07), P <0.0001, noninferiority confirmed
Faster aspart postmeal vs. IAsp: 0.04% (95% CI −0.04 to 0.12), P <0.0001, noninferiority confirmed 
1-hour PPG:
Faster aspart mealtime vs IAsp: −25.44 (95% CI −36.12 to −14.76), P <0.0001 in favor of faster aspart mealtime
Faster aspart postmeal vs. IAsp: 12.38 (95% CI 1.65–23.11), P = 0.0238 in favor of IAsp
2-hour PPG:
Faster aspart mealtime vs. IAsp: −16.73 (95% CI −29.26 to −4.20), P = 0.0089 in favor of faster aspart mealtime
2-hour PPG:
Faster aspart postmeal vs. IAsp: 1.08 (95% CI −11.49 to 13.66), P = NS 
onset 1 (52 weeks; initial 26 weeks plus an additional 26 weeks) 
  • T1D; n = 761

  • Duration of diabetes: 20.9 ± 12.9 vs. 19.8 ± 11.8 years

  • Baseline A1C: 7.6 ± 0.7 vs. 7.6 ± 0.7%

  • Baseline FPG: 151.4 ± 55.8 vs. 141.8 ± 50.2 mg/dL

 
Faster aspart mealtime (0–2 minutes before meals) vs. IAsp mealtime (0–2 minutes before meals) Faster aspart mealtime vs. IAsp: −0.10% (95% CI −0.19 to −0.00), P = 0.0424, noninferiority confirmed 1-hour PPG:
Faster aspart mealtime vs. IAsp: −16.7 (95% CI −28.5 to −5.0), P = 0.0054 in favor of faster aspart mealtime
2-hour PPG:
Faster aspart mealtime vs. IAsp: −7.2 (95% CI −21.5 to 7.13), P = NS 
onset 2 (26 weeks) 
  • T2D; n = 689

  • Duration of diabetes: 13.2 ± 6.7 vs. 12.3 ± 6.3 years

  • Baseline A1C: 8.0 ± 0.7 vs. 7.9 ± 0.7%

  • Baseline FPG: 121.7 ± 32.7 vs. 122.7 ± 35.1 mg/dL

 
Faster aspart mealtime (0–2 minutes before meals) vs. IAsp mealtime (0–2 minutes before meals) Faster aspart mealtime vs. IAsp: −0.02% (95% CI −0.15 to 0.10), P <0.0001, noninferiority confirmed 1-hour PPG:
Faster aspart mealtime vs. IAsp: −10.63 (95% CI −19.56 to −1.69), P = 0.0198 in favor of faster aspart mealtime
2-hour PPG:
Faster aspart mealtime vs. IAsp: −6.57 (95% CI −14.54 to 1.41), P = NS 
PRONTO-T1D (26 weeks) 
  • T1D; n = 1,222

  • Duration of diabetes: 18.8 ± 12.3 vs. 18.8 ± 11.7 vs. 19.1 ± 12.0 years

  • Baseline A1C: 7.34 ± 0.65 vs. 7.36 ± 0.64 vs. 7.33 ± 0.67%

  • Baseline FPG: NR

 
URLi mealtime (0–2 minutes before meals) vs. URLi postmeal (20 minutes after meals) vs. lispro mealtime (0–2 minutes before meals) URLi mealtime vs. lispro: −0.08% (95% CI −0.16 to 0.00), P = 0.06, noninferiority confirmed
URLi postmeal vs. lispro: 0.13% (95% CI 0.04–0.22), P = 0.003, noninferiority confirmed 
1-hour PPG:
URLi mealtime vs. lispro: −27.9 (95% CI −35.3 to −20.5), P <0.001 in favor of URLi mealtime
URLi postmeal vs. lispro: 13.1 (95% CI 5.0–21.4), P <0.05 in favor of lispro
URLi postmeal vs. URLi mealtime: 41.0 (95% CI 32.9–39.1), P <0.001 in favor of URLi mealtime
2-hour PPG:
URLi mealtime vs. lispro: −31.1 (95% CI −41.0 to −21.2), P <0.001 in favor of URLi mealtime
URLi postmeal vs. lispro: 13.1 (95% CI −17.6 to 4.3), P = NS
URLi postmeal vs. URLi mealtime: 24.5 (95% CI 13.5–35.5), P <0.001 in favor of URLi mealtime 
PRONTO-T2D (26 weeks) 
  • T2D; n = 673

  • Duration of diabetes: 16.4 ± 7.8 vs. 6.6 ± 7.9 years

  • Baseline A1C: 7.27 ± 0.68 vs. 7.31 ± 0.72%

  • Baseline FPG: NR

 
URLi mealtime (0–2 minutes before meals) vs. lispro mealtime (0–2 minutes before meals) URLi mealtime vs. lispro: 0.06% (95% CI −0.05 to 0.16), P = NR, noninferiority confirmed 1-hour PPG:
URLi mealtime vs. lispro: −11.9 (95% CI −18.2 to −5.4), P <0.001 in favor of URLi mealtime
2-hour PPG:
URLi mealtime vs. lispro: −17.3 (95% CI −25.4 to −9.4), P <0.001 in favor of URLi mealtime 
TrialPatient DemographicsIntervention(s)A1C Outcome (ETD, %)PPG Outcome (ETD, mg/dL)
onset 1 (26 weeks) 
  • T1D; n = 1,143

  • Duration of diabetes: 20.9 ± 12.9 vs. 19.5 ± 12.1 vs. 19.3 ± 11.8 years

  • Baseline A1C: 7.6 ± 0.7 vs. 7.6 ± 0.7 vs. 7.6 ± 0.7%

  • Baseline FPG: 151.4 ± 55.8 vs. 145.6 ± 57.6 vs. 141.8 ± 50.2 mg/dL

 
Faster aspart mealtime (0–2 minutes before meals) vs. faster aspart postmeal (20 minutes after meals) vs. IAsp mealtime (0–2 minutes before meals) Faster aspart mealtime vs. IAsp: −0.15% (95% CI −0.23 to −0.07), P <0.0001, noninferiority confirmed
Faster aspart postmeal vs. IAsp: 0.04% (95% CI −0.04 to 0.12), P <0.0001, noninferiority confirmed 
1-hour PPG:
Faster aspart mealtime vs IAsp: −25.44 (95% CI −36.12 to −14.76), P <0.0001 in favor of faster aspart mealtime
Faster aspart postmeal vs. IAsp: 12.38 (95% CI 1.65–23.11), P = 0.0238 in favor of IAsp
2-hour PPG:
Faster aspart mealtime vs. IAsp: −16.73 (95% CI −29.26 to −4.20), P = 0.0089 in favor of faster aspart mealtime
2-hour PPG:
Faster aspart postmeal vs. IAsp: 1.08 (95% CI −11.49 to 13.66), P = NS 
onset 1 (52 weeks; initial 26 weeks plus an additional 26 weeks) 
  • T1D; n = 761

  • Duration of diabetes: 20.9 ± 12.9 vs. 19.8 ± 11.8 years

  • Baseline A1C: 7.6 ± 0.7 vs. 7.6 ± 0.7%

  • Baseline FPG: 151.4 ± 55.8 vs. 141.8 ± 50.2 mg/dL

 
Faster aspart mealtime (0–2 minutes before meals) vs. IAsp mealtime (0–2 minutes before meals) Faster aspart mealtime vs. IAsp: −0.10% (95% CI −0.19 to −0.00), P = 0.0424, noninferiority confirmed 1-hour PPG:
Faster aspart mealtime vs. IAsp: −16.7 (95% CI −28.5 to −5.0), P = 0.0054 in favor of faster aspart mealtime
2-hour PPG:
Faster aspart mealtime vs. IAsp: −7.2 (95% CI −21.5 to 7.13), P = NS 
onset 2 (26 weeks) 
  • T2D; n = 689

  • Duration of diabetes: 13.2 ± 6.7 vs. 12.3 ± 6.3 years

  • Baseline A1C: 8.0 ± 0.7 vs. 7.9 ± 0.7%

  • Baseline FPG: 121.7 ± 32.7 vs. 122.7 ± 35.1 mg/dL

 
Faster aspart mealtime (0–2 minutes before meals) vs. IAsp mealtime (0–2 minutes before meals) Faster aspart mealtime vs. IAsp: −0.02% (95% CI −0.15 to 0.10), P <0.0001, noninferiority confirmed 1-hour PPG:
Faster aspart mealtime vs. IAsp: −10.63 (95% CI −19.56 to −1.69), P = 0.0198 in favor of faster aspart mealtime
2-hour PPG:
Faster aspart mealtime vs. IAsp: −6.57 (95% CI −14.54 to 1.41), P = NS 
PRONTO-T1D (26 weeks) 
  • T1D; n = 1,222

  • Duration of diabetes: 18.8 ± 12.3 vs. 18.8 ± 11.7 vs. 19.1 ± 12.0 years

  • Baseline A1C: 7.34 ± 0.65 vs. 7.36 ± 0.64 vs. 7.33 ± 0.67%

  • Baseline FPG: NR

 
URLi mealtime (0–2 minutes before meals) vs. URLi postmeal (20 minutes after meals) vs. lispro mealtime (0–2 minutes before meals) URLi mealtime vs. lispro: −0.08% (95% CI −0.16 to 0.00), P = 0.06, noninferiority confirmed
URLi postmeal vs. lispro: 0.13% (95% CI 0.04–0.22), P = 0.003, noninferiority confirmed 
1-hour PPG:
URLi mealtime vs. lispro: −27.9 (95% CI −35.3 to −20.5), P <0.001 in favor of URLi mealtime
URLi postmeal vs. lispro: 13.1 (95% CI 5.0–21.4), P <0.05 in favor of lispro
URLi postmeal vs. URLi mealtime: 41.0 (95% CI 32.9–39.1), P <0.001 in favor of URLi mealtime
2-hour PPG:
URLi mealtime vs. lispro: −31.1 (95% CI −41.0 to −21.2), P <0.001 in favor of URLi mealtime
URLi postmeal vs. lispro: 13.1 (95% CI −17.6 to 4.3), P = NS
URLi postmeal vs. URLi mealtime: 24.5 (95% CI 13.5–35.5), P <0.001 in favor of URLi mealtime 
PRONTO-T2D (26 weeks) 
  • T2D; n = 673

  • Duration of diabetes: 16.4 ± 7.8 vs. 6.6 ± 7.9 years

  • Baseline A1C: 7.27 ± 0.68 vs. 7.31 ± 0.72%

  • Baseline FPG: NR

 
URLi mealtime (0–2 minutes before meals) vs. lispro mealtime (0–2 minutes before meals) URLi mealtime vs. lispro: 0.06% (95% CI −0.05 to 0.16), P = NR, noninferiority confirmed 1-hour PPG:
URLi mealtime vs. lispro: −11.9 (95% CI −18.2 to −5.4), P <0.001 in favor of URLi mealtime
2-hour PPG:
URLi mealtime vs. lispro: −17.3 (95% CI −25.4 to −9.4), P <0.001 in favor of URLi mealtime 

ETD, estimated treatment difference; FPG, fasting plasma glucose; NR, not reported; NS, not significant; T1D, type 1 diabetes; T2D, type 2 diabetes.

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