PMID- 36546064
OWN - NLM
STAT- MEDLINE
DCOM- 20221223
LR  - 20230106
IS  - 2095-9281 (Electronic)
IS  - 2095-9273 (Linking)
VI  - 67
IP  - 17
DP  - 2022 Sep 15
TI  - Ultra rapid lispro improves postprandial glucose control versus lispro in 
      combination with insulin glargine/degludec in adults with type 2 diabetes: a 
      prospective, randomized, double-blind, phase 3 trial.
PG  - 1785-1791
LID - S2095-9273(22)00347-4 [pii]
LID - 10.1016/j.scib.2022.08.002 [doi]
AB  - Ultra rapid lispro (URLi) is a novel formulation of insulin lispro designed to 
      more closely match the physiological insulin response to a meal, with the aim of 
      improving postprandial glucose (PPG) control. We conducted a multinational, 
      multicenter, randomized, double-blind, treat-to-target, 26-week, phase 3 trial to 
      evaluate the efficacy and safety of URLi in adults with type 2 diabetes (T2D). 
      After an 8-week lead-in period during which basal insulin glargine or degludec 
      was optimized, adults with T2D were randomized (2:1) to prandial URLi (n = 395) 
      or lispro (n = 200). The primary endpoint was non-inferiority of URLi versus 
      lispro in glycated hemoglobin A1c (HbA(1c)) change from baseline to week 26. 
      Multiplicity-adjusted analyses were performed to assess the superiority of URLi 
      in 1- and 2-h PPG excursions during a mixed-meal tolerance test (MMTT) and 
      HbA(1c) change at week 26. URLi showed non-inferiority for HbA(1c) change at week 
      26 versus lispro (least-squares mean [LSM] difference, 0.07%; 95% confidence 
      interval: -0.07, 0.21). HbA(1c) was reduced by 0.56% and 0.63% with URLi and 
      lispro, respectively, with no significant treatment difference (P = 0.321). URLi 
      provided superior PPG excursion control versus lispro at 1 h (LSM difference: 
      -14.6 mg/dL, P < 0.001) and 2 h (LSM difference: -21.8 mg/dL, P < 0.001) as well 
      as other time points (30-240 min) during the MMTT. Incremental area under the 
      glucose curve during the MMTT was also significantly lower with URLi versus 
      lispro. The safety profiles were generally similar between treatment groups. In 
      conclusion, URLi was superior to lispro for PPG control, with non-inferiority in 
      HbA(1c) improvement, in adults with T2D.
CI  - Copyright (c) 2022 Science China Press. Published by Elsevier B.V. All rights 
      reserved.
FAU - Zhou, Jian
AU  - Zhou J
AD  - Department of Endocrinology and Metabolism, Shanghai Jiao Tong University School 
      of Medicine Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, 
      Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes 
      Mellitus, Shanghai 200233, China.
FAU - Chen, Si
AU  - Chen S
AD  - Department of Endocrinology and Metabolism, Shanghai Jiao Tong University School 
      of Medicine Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, 
      Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes 
      Mellitus, Shanghai 200233, China.
FAU - Cheng, Jie
AU  - Cheng J
AD  - Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai 200041, China.
FAU - Zhu, Jiankun
AU  - Zhu J
AD  - Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai 200041, China.
FAU - Lou, Ying
AU  - Lou Y
AD  - Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai 200041, China.
FAU - Bao, Yuqian
AU  - Bao Y
AD  - Department of Endocrinology and Metabolism, Shanghai Jiao Tong University School 
      of Medicine Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, 
      Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes 
      Mellitus, Shanghai 200233, China.
FAU - Jia, Weiping
AU  - Jia W
AD  - Department of Endocrinology and Metabolism, Shanghai Jiao Tong University School 
      of Medicine Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, 
      Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes 
      Mellitus, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220804
PL  - Netherlands
TA  - Sci Bull (Beijing)
JT  - Science bulletin
JID - 101655530
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 0 (Insulin Lispro)
RN  - 54Q18076QB (insulin degludec)
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Insulin Glargine/adverse effects
MH  - Insulin Lispro/therapeutic use
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Blood Glucose
MH  - Hypoglycemic Agents/therapeutic use
MH  - Prospective Studies
OTO - NOTNLM
OT  - Lispro
OT  - Phase 3 trial
OT  - Postprandial glucose control
OT  - Type 2 diabetes
OT  - Ultra rapid lispro
EDAT- 2022/12/23 06:00
MHDA- 2022/12/24 06:00
CRDT- 2022/12/22 04:44
PHST- 2022/03/24 00:00 [received]
PHST- 2022/05/25 00:00 [revised]
PHST- 2022/07/27 00:00 [accepted]
PHST- 2022/12/22 04:44 [entrez]
PHST- 2022/12/23 06:00 [pubmed]
PHST- 2022/12/24 06:00 [medline]
AID - S2095-9273(22)00347-4 [pii]
AID - 10.1016/j.scib.2022.08.002 [doi]
PST - ppublish
SO  - Sci Bull (Beijing). 2022 Sep 15;67(17):1785-1791. doi: 
      10.1016/j.scib.2022.08.002. Epub 2022 Aug 4.