ONLINE_Supplementary_Material_PRONTO_T2D.docx (165.33 kB)

Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro with Lispro in a Basal-Bolus Regimen in Patients with Type 2 Diabetes: PRONTO-T2D

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posted on 10.07.2020 by Thomas Blevins, Qianyi Zhang, Juan P Frias, Hideaki Jinnouchi, Annette M Chang, PRONTO-T2D Investigators
OBJECTIVE

To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen.

RESEARCH DESIGN AND METHODS

This was a Phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi (n=336) or lispro (n=337) injected 0 to 2 minutes prior to meals. Patients could continue metformin and/or sodium glucose co-transporter-2 inhibitor. The primary end point was change from baseline HbA1c to 26 weeks (noninferiority margin 0.4%), with multiplicity adjusted objectives for postprandial glucose (PPG) excursions during a standardized meal test.

RESULTS

HbA1c improved for both URLi and lispro and noninferiority was confirmed: estimated treatment difference (ETD) +0.06% (95% CI -0.05; 0.16). Mean change in HbA1C was -0.38% for URLi and -0.43% for lispro, with an end of treatment HbA1c of 6.92% and 6.86% respectively. URLi was superior to lispro in controlling 1- and 2-h PPG excursions: 1-hour ETD, -0.66 mmol/L (95% CI -1.01, -0.30); 2-hour ETD, -0.96 mmol/L (-1.41, -0.52). Significantly lower PPG excursions were evident from 0.5 to 4 hours postmeal with URLi treatment. There were no significant treatment differences in rates of severe or documented hypoglycemia (<3 mmol/L). Incidence of overall treatment-emergent adverse events was similar between treatments.

CONCLUSIONS

URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA1c and superior to lispro for PPG control in patients with type 2 diabetes.

Funding

This study was funded by Eli Lilly and Company.

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