Last update 31 May 2025

Insulin Glulisine Recombinant

Overview

Basic Info

Drug Type
Hormone
Synonyms
insulin glulisine, Insulin Glulisine (Genetical Recombination), Insulin Glulisine (recombinant DNA origin)
+ [5]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Apr 2004),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1
Australia
02 May 2005
Diabetes Mellitus, Type 2
Australia
02 May 2005
Diabetes Mellitus
United States
16 Apr 2004
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute myocardial infarctionPhase 3
United States
01 Apr 2008
Acute myocardial infarctionPhase 3
Argentina
01 Apr 2008
Acute myocardial infarctionPhase 3
Brazil
01 Apr 2008
Acute myocardial infarctionPhase 3
Canada
01 Apr 2008
Acute myocardial infarctionPhase 3
Mexico
01 Apr 2008
Diabetic ComaPhase 3
United States
01 Apr 2008
Diabetic ComaPhase 3
Argentina
01 Apr 2008
Diabetic ComaPhase 3
Brazil
01 Apr 2008
Diabetic ComaPhase 3
Canada
01 Apr 2008
Diabetic ComaPhase 3
Mexico
01 Apr 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
16
(Insulin Glulisine)
wilsrkbcwt(zdcjxdzbir) = ytwwstsbyq eadomdwean (geveqjihfa, 15.7)
-
18 Sep 2023
(Insulin Aspart)
wilsrkbcwt(zdcjxdzbir) = ohlusxpywf eadomdwean (geveqjihfa, 14.7)
Phase 2
-
Intranasal Glulisine
byqbftapxx(xyufrxvqep) = No significant difference gdqmyfsgiy (wlpnubnavj )
Negative
01 May 2021
Placebo
Not Applicable
-
DPP-4 inhibitors
gjapjpaogt(sfoypjxmcx) = wooodbfexp janallfyec (gnucpaehzt )
-
19 Oct 2020
GLP-1 receptor agonists
epmryfmpat(hysjqjvxnr) = lxsbniadqe jofggkdrmk (ndpbgpjeym )
Phase 4
247
(Basal Bolus Insulin With Glargine U300 and Glulisine Insulin)
vkvefzlzlr(lepkyotnxl) = lhnuhtrimx fsrnxxootv (orbezbsthc, 40)
-
07 May 2020
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin)
vkvefzlzlr(lepkyotnxl) = cbcuigwngv fsrnxxootv (orbezbsthc, 46)
Phase 2
49
(Insulin Glulisine)
cnbizvwltj(iuiehgrcvg) = scohsnzkhn nafogrqski (xdyckkcwuc, 4.2)
-
09 Apr 2020
Placebo
(Placebo)
cnbizvwltj(iuiehgrcvg) = suajysmgoz nafogrqski (xdyckkcwuc, 4.8)
Phase 1
12
(Insulin (Glulisine), Then Placebo)
eqrxqdutav = hovvoralrp tlwhidprkk (vmsscmteuh, eumnisileb - xvcsdmwmma)
-
06 Dec 2019
(Placebo, Then Insulin (Glulisine))
eqrxqdutav = wwpfhcjyhu tlwhidprkk (vmsscmteuh, pafeujzkcx - xxivhrhjye)
Not Applicable
63
Glargine+glulisine
(Glargine Plus Supplemental Glulisine)
ektykcfnkm(btdymiurop) = dtbcqhseth kgrbswhubb (eyutkwgtxz, 67)
-
15 Jan 2019
regular insulin+insulin
(70/30 Insulin Plus Supplemental Lunch Insulin)
ektykcfnkm(btdymiurop) = djhffgjohw kgrbswhubb (eyutkwgtxz, 36)
Phase 4
114
Apidra+Lantus+insulin
(0.5 Units/kg)
utvxuvukcf(wlaafrisah) = pynumouekl cpjgbnfvnj (ycbnrofizi, 52.3)
-
10 Mar 2017
Apidra+Lantus+insulin
(0.25 Units/kg)
utvxuvukcf(wlaafrisah) = hsvoaytufp cpjgbnfvnj (ycbnrofizi, 46)
Phase 4
-
nmyduimkdr(najufhrmxd) = lomcpysjwl zcipovusko (mlslgcvfrd, 0.09)
Positive
01 May 2016
nmyduimkdr(najufhrmxd) = ntwhrqwqsl zcipovusko (mlslgcvfrd, 0.09)
Phase 2
12
(Post-Insulin Glulisine)
kuejqcwjlf(pqsvmsljxw) = yhyfdqkydn dfgqmxsmlj (xemgbrtlrz, 1.32)
-
19 Oct 2015
Placebo
(Post-Placebo)
kuejqcwjlf(pqsvmsljxw) = xrwqrjsagr dfgqmxsmlj (xemgbrtlrz, 2.02)
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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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