Last update 16 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

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
701
Sitagliptin 100 mg + Metformin Immediate-Release
bukmhhwkol(qpvltriazs) = ipncpkassg paosipgcqd (vqcjveqkpy )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release
bukmhhwkol(qpvltriazs) = fpbnewkgdi paosipgcqd (vqcjveqkpy )
FDA_CDER
ManualManual
Not Applicable
278
Sitagliptin 100 mg +Metformin Immediate-Release + Rosiglitazone
fjipnqeiym(zyrrajudrt) = huhrccsnhw cobxwboqvr (oigbrfhipo )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release + Rosiglitazone
fjipnqeiym(zyrrajudrt) = fbjqkdzqzk cobxwboqvr (oigbrfhipo )
FDA_CDER
ManualManual
Not Applicable
-
Sitagliptin 100 mg + Metformin Immediate-Release
pcopucidds(mvjrfmovcw) = voxfgneqbq fcnmjrbvcy (iquzlmwkpd )
Non-inferior
18 Jul 2024
Glipizide + Metformin Immediate-Release
pcopucidds(mvjrfmovcw) = ylkukomalr fcnmjrbvcy (iquzlmwkpd )
FDA_CDER
ManualManual
Not Applicable
746
Sitagliptin 100 mg + Metformin + Insulin Glargine
zjydjlmeep(gxmhdsqwce) = bocwkxyomo iaufhgglcs (ivzkxlrius )
Positive
18 Jul 2024
Placebo + Metformin + Insulin Glargine
zjydjlmeep(gxmhdsqwce) = mkwugperlf iaufhgglcs (ivzkxlrius )
FDA_CDER
ManualManual
Not Applicable
441
Sitagliptin 100 mg + Metformin Immediate-Release and Glimepiride
ynaqotvevk(jeoiwmscge) = oppxuorafm irvhleawbr (pkaponqhkj )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release and Glimepiride
ynaqotvevk(jeoiwmscge) = rnsphecwvn irvhleawbr (pkaponqhkj )
FDA_CDER
ManualManual
Not Applicable
641
Sitagliptin 100 mg + Metformin Immediate-Release + Insulin
hnjpnetyzn(utzbbftuuq) = dpmznkagok jsmtbmlquf (zsatonuszy )
Positive
18 Jul 2024
Placebo + Metformin Immediate-Release + Insulin
hnjpnetyzn(utzbbftuuq) = qhooabdnci jsmtbmlquf (zsatonuszy )
FDA_CDER
ManualManual
Not Applicable
1,091
Placebo
fqteyeschz(ozglmykvtw) = viyvmymuwq hysmmkhsgw (mzsegacmwe )
Positive
18 Jul 2024
Sitagliptin 100 mg once daily
fqteyeschz(ozglmykvtw) = uonawebzrc hysmmkhsgw (mzsegacmwe )
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Regulation

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