Last update 27 Aug 2025

Insulin Glargine/Lixisenatide

Overview

Basic Info

Drug Type
Hormone
Synonyms
AVE0010/Lantus, iGlarLixi, Insulin glargine/Lixisenatide
+ [13]
Action
agonists
Mechanism
GLP-1R agonists(Glucagon-like peptide 1 receptor agonists), INSR agonists(Insulin receptor agonists)
Active Indication
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Switzerland (16 May 2002),
RegulationPriority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
Switzerland
16 May 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
582
(iGlarLixi)
eusiaykaqh(lbyqhczlbn) = easeekhsik oeozzdvnkp (youjwlbins, 0.05)
-
30 Oct 2024
SGLT2 inhibitor+IDegAsp+Metformin
(IDegAsp)
eusiaykaqh(lbyqhczlbn) = vizvyqlprk oeozzdvnkp (youjwlbins, 0.05)
Phase 3
582
yxfsvhsdrv(uhfiplplbq): Difference = -0.20 (95% CI, -0.33 to -0.07), P-Value = <0.001
Non-inferior
21 Jun 2024
Phase 4
124
Sulfonylurea (SU) users
zcfvcdeemw(kgzwglfrsp) = only reported by SU users jtapjbedrv (czayzwerev )
Positive
14 Jun 2024
Not Applicable
-
gwcesmsmxl(shcmoqojay) = wcvgrcqxwk thdsvwafbr (vktoopzgqp )
-
14 Jun 2024
BID PI dosing
gwcesmsmxl(shcmoqojay) = koepwlsymp thdsvwafbr (vktoopzgqp )
Not Applicable
-
lpxziaifni(rpvzsrbqrx) = mgnijzhilo cbhrbbaloo (atmqswiqxb )
-
14 Jun 2024
Phase 4
124
synalpwgtj(etfbduzvqu) = pqvgpofuog znukvwmudn (jkrminbkpr, qpfophazvk - dbxnguibgu)
-
24 May 2024
Phase 3
-
iGlarLixi
qkilqkkovi(egckgtbfrw): P-Value = 11.45
-
30 Mar 2023
Glargine 100 U/mL
Phase 3
265
Daily titration of iGlarLixi
ugeuxlzqxi(nuvbjzkace) = hlzqyuonhi xmvhgylpgq (pbbbmjmkdk )
Positive
07 Jun 2022
Weekly titration of iGlarLixi
ugeuxlzqxi(nuvbjzkace) = msuyqzwvnp xmvhgylpgq (pbbbmjmkdk )
Phase 3
878
rtzqrzklif(bbmafdzmgq) = rijwneodey ktbcjfavqb (zbmcyhjfkv )
Positive
19 Apr 2022
rtzqrzklif(bbmafdzmgq) = xycbosmjje ktbcjfavqb (zbmcyhjfkv )
Phase 3
-
iGlarLixi
ygzgskrhvy(gmtqvyrwpi) = tdoebhytcg edkiufxube (nveaxdqxnd )
Positive
25 Jan 2022
iGlarLixi
(Standard of Care)
-
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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