Generated Narrative: ResearchStudy JPMA0001-jpn

Language: en

Profile: M11 Research Study Profile

M11 Research Study Extension

  • originalProtocol: Protocol Not Amended
  • versionDate: 2026-01-14

Narrative Elements: Composition JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria)

identifier: Sponsor Identifier/JPMA001 (use: usual, )

version: 2.0

title: 経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験

Labels

-TypeValue
*Short title2型糖尿病患者への投与

status: Active

phase: Phase III Trial

Recruitments

-Eligibility
*Group Japanese Protocol from Vulcan UDP Eligibility Criteria
 <label> <type> <coding> <system value="http://hl7.org/fhir/title-type"/> <code value="short-title"/> <display value="Short title"/> </coding> </type> <value value="2型糖尿病患者への投与"/> </label> <status value="active"/> <phase> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C15602"/> <display value="Phase III Trial"/> </coding> </phase> <recruitment> <eligibility> <reference value="Group/JPMA0001-Criteria-JPN"/> </eligibility> </recruitment> </ResearchStudy>