PMID- 32072742
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 22 Suppl 4
DP  - 2020 Sep
TI  - Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination 
      (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately 
      controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L 
      randomized clinical trial.
PG  - 3-13
LID - 10.1111/dom.14005 [doi]
AB  - AIMS: To assess efficacy and safety of fixed-ratio (1:1) combination insulin 
      glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), 
      with metformin, in Japanese patients with type 2 diabetes mellitus (T2DM) 
      inadequately controlled on basal insulin and oral antidiabetic drugs (OADs). 
      MATERIALS AND METHODS: This 26-week, randomized, open-label study compared 
      iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and 
      hemoglobin (Hb) A1c >/=7.5% to </=9.5%, treated with basal insulin and 1 or 2 OADs. 
      Five hundred and twelve patients were randomized after a 12-week run-in, when 
      iGlar was introduced and/or further titrated and OADs other than metformin were 
      stopped. The primary endpoint was change in HbA1c from baseline to week 26. 
      RESULTS: iGlarLixi (n = 255) demonstrated significantly greater reductions in 
      HbA1c (-1.27%) than iGlar (n = 257, -0.53%) (LS mean difference: -0.74%, 
      P < .0001) at week 26, confirming the superiority of iGlarLixi. Significantly, 
      more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs 16.0% for 
      iGlar). iGlarLixi patients lost weight in contrast to iGlar patients (-0.51 kg vs 
      +0.55 kg). Documented symptomatic hypoglycemia (plasma glucose </= 3.9 mmol/L) was 
      observed in 18.8% of iGlarLixi patients vs 16.7% of iGlar patients. iGlarLixi 
      patients had more gastrointestinal-related adverse events than iGlar patients 
      (33.3% vs 8.6%), primarily nausea (16.9% vs 0.8%). However, the treatment was 
      generally well-tolerated. CONCLUSIONS: A once-daily injection of iGlarLixi with 
      metformin is an effective, well-tolerated, and simple therapeutic intervention 
      providing significant improvement in glycemic control in Japanese patients with 
      T2DM inadequately controlled on basal insulin and up to two OADs. Clinical Trial 
      Number: NCT02752412.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Kaneto, Hideaki
AU  - Kaneto H
AD  - Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 
      Kurashiki, Japan.
FAU - Takami, Akane
AU  - Takami A
AD  - Research & Development, Sanofi K.K., Tokyo, Japan.
FAU - Spranger, Robert
AU  - Spranger R
AD  - Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland 
      GmbH, Frankfurt, Germany.
FAU - Amano, Atsushi
AU  - Amano A
AUID- ORCID: 0000-0003-3698-6871
AD  - Research & Development, Sanofi K.K., Tokyo, Japan.
FAU - Watanabe, Daisuke
AU  - Watanabe D
AD  - Research & Development, Sanofi K.K., Tokyo, Japan.
FAU - Niemoeller, Elisabeth
AU  - Niemoeller E
AD  - Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland 
      GmbH, Frankfurt, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02752412
GR  - Sanofi/International
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Drug Combinations)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 74O62BB01U (lixisenatide)
SB  - IM
MH  - Adult
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Drug Combinations
MH  - Glycated Hemoglobin
MH  - Humans
MH  - *Hypoglycemic Agents
MH  - Insulin Glargine/adverse effects
MH  - Japan
MH  - Peptides
OTO - NOTNLM
OT  - GLP-1 analogue
OT  - basal insulin
OT  - glycemic control
OT  - metformin
OT  - phase 3 study
OT  - type 2 diabetes
EDAT- 2020/02/20 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/02/20 06:00
PHST- 2019/12/13 00:00 [received]
PHST- 2020/02/06 00:00 [revised]
PHST- 2020/02/14 00:00 [accepted]
PHST- 2020/02/20 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/02/20 06:00 [entrez]
AID - 10.1111/dom.14005 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2020 Sep;22 Suppl 4:3-13. doi: 10.1111/dom.14005.