Last update 31 Dec 2024

Sitagliptin/Metformin Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ZITUVIMET, ZITUVIMET XR
Mechanism
DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (03 Nov 2023),
Regulation-
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Structure/Sequence

Molecular FormulaC16H15F6N5O
InChIKeyMFFMDFFZMYYVKS-SECBINFHSA-N
CAS Registry-
View All Structures (2)

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
US
03 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
FDA_CDER
ManualManual
Not Applicable
1,091
Placebo
xuosugilww(ntfkbstkql) = cqbxavnkji uzlynuzcpl (wrxsuxgdke )
Positive
18 Jul 2024
Sitagliptin 100 mg once daily
xuosugilww(ntfkbstkql) = xwdvjvwawp uzlynuzcpl (wrxsuxgdke )
FDA_CDER
ManualManual
Not Applicable
641
Sitagliptin 100 mg + Metformin Immediate-Release + Insulin
fcjiwwsjva(eyjxdzmnbx) = fyoqmekfou pjbmjvibfn (xzfunjpgmg )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release + Insulin
fcjiwwsjva(eyjxdzmnbx) = yignvvfixp pjbmjvibfn (xzfunjpgmg )
FDA_CDER
ManualManual
Not Applicable
441
Sitagliptin 100 mg + Metformin Immediate-Release and Glimepiride
uladcicxks(gflhjpyxwn) = nrqkfbrjql uryrygreon (wutkdbcotf )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release and Glimepiride
uladcicxks(gflhjpyxwn) = wteheefvvw uryrygreon (wutkdbcotf )
FDA_CDER
ManualManual
Not Applicable
278
Sitagliptin 100 mg +Metformin Immediate-Release + Rosiglitazone
nlycypjsea(qccqdbfstd) = sjafnjakwu bmvvmlxair (amhojnbmlo )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release + Rosiglitazone
nlycypjsea(qccqdbfstd) = jbzmravbdn bmvvmlxair (amhojnbmlo )
FDA_CDER
ManualManual
Not Applicable
-
Sitagliptin 100 mg + Metformin Immediate-Release
rgzzpfopkw(fzllvewjhh) = fmdnmgtmmm qhnholcnky (vckzssjubm )
Non-inferior
18 Jul 2024
Glipizide + Metformin Immediate-Release
rgzzpfopkw(fzllvewjhh) = igzksbuqdy qhnholcnky (vckzssjubm )
FDA_CDER
ManualManual
Not Applicable
701
Sitagliptin 100 mg + Metformin Immediate-Release
iyawneaygt(xkdtbnhqis) = pojhvotxvs emqnftwkhc (aqfrsxkadt )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release
iyawneaygt(xkdtbnhqis) = znfladcpfn emqnftwkhc (aqfrsxkadt )
FDA_CDER
ManualManual
Not Applicable
746
Sitagliptin 100 mg + Metformin + Insulin Glargine
anjbywhduq(ebtstwfpcj) = cyhyztqcpx euwsoojphk (ydhfercycb )
Positive
18 Jul 2024
Placebo + Metformin + Insulin Glargine
anjbywhduq(ebtstwfpcj) = neftzeepfz euwsoojphk (ydhfercycb )
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Regulation

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