Unknown

Dataset Information

0

Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis.


ABSTRACT: INTRODUCTION:The aim of this study was to evaluate the efficacy and safety of ultra-rapid lispro (URLi) versus lispro in a subgroup analysis of Japanese adults with type 2 diabetes mellitus (T2DM) from the phase 3 PRONTO-T2D trial. METHODS:After an 8-week lead-in period during which patients transitioned to insulin lispro 3 times a day before main meals in association with basal insulin (glargine or degludec), the patients were randomized to 26 weeks of double-blind URLi or lispro injected immediately prior to meals. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline to week 26 between URLi and lispro. The multiplicity-adjusted objectives were 1- and 2-h postprandial glucose (PPG) excursions after a test meal and change in HbA1c from baseline to week 26 in the URLi and lispro groups. RESULTS:Results were obtained from prespecified exploratory analyses of 26-week data in Japanese patients randomized to receive URLi (n?=?47) or lispro (n?=?46). Mean baseline HbA1c levels significantly improved during the lead-in period to a baseline value of 7.50% and 7.60% in patients subsequently randomized to the URLi and lispro treatment groups, respectively. At week 26, the least squares mean (LSM) difference in HbAc1 between the URLi and lispro groups was 0.13% (95% confidence interval [CI] - 0.12 to 0.39) (1.4 mmol/mol, 95% CI - 1.3 to 4.2). Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro. LSM differences in PPG excursions at week 26 were - 10.5 mg/dL (95% CI - 32.7 to 11.7) (- 0.58 mmol/L, 95% CI - 1.82 to 0.65) at 1 h and - 14.9 mg/dL (95% CI - 40.3 to 10.5) (- 0.83 mmol/L, 95% CI - 2.24 to 0.58) at 2 h. There were no significant differences between treatments in rates of severe/overall hypoglycemia or incidence of treatment-emergent adverse events. CONCLUSIONS:URLi administered as prandial insulin in combination with basal insulin provides effective glycemic control when administered immediately before a meal in Japanese patients with T2DM. URLi was well tolerated in this population. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03214380.

SUBMITTER: Jinnouchi H 

PROVIDER: S-EPMC7434814 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

altmetric image

Publications

Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis.

Jinnouchi Hideaki H   Imori Makoto M   Nishiyama Hiroshi H   Imaoka Takeshi T  

Diabetes therapy : research, treatment and education of diabetes and related disorders 20200729 9


<h4>Introduction</h4>The aim of this study was to evaluate the efficacy and safety of ultra-rapid lispro (URLi) versus lispro in a subgroup analysis of Japanese adults with type 2 diabetes mellitus (T2DM) from the phase 3 PRONTO-T2D trial.<h4>Methods</h4>After an 8-week lead-in period during which patients transitioned to insulin lispro 3 times a day before main meals in association with basal insulin (glargine or degludec), the patients were randomized to 26 weeks of double-blind URLi or lispro  ...[more]

Similar Datasets

| S-EPMC7435141 | biostudies-literature
| S-EPMC7770265 | biostudies-literature
| S-EPMC8385092 | biostudies-literature
| S-EPMC9309112 | biostudies-literature
| S-EPMC7539952 | biostudies-literature
| S-EPMC7698997 | biostudies-literature
| S-EPMC7716902 | biostudies-literature
| S-EPMC8585827 | biostudies-literature
| S-EPMC7716921 | biostudies-literature
| S-EPMC10087819 | biostudies-literature