♦Basic information
JapicCTI-No. JapicCTI-142548
♦Title of the study
Title of the study Clinical Pharmaclogical study of TS-071 in Patient With Type 2 Diabetetes Mellitus(Evaluation of glycemic variability using continuous glucose monitoring)
Public title of the study
Primary sponsor Taisho Pharmaceutical co., LTD
Secondary sponsor  
Study Type interventional (drug)
Summary The purpose of this study is to assess the continuous glucose value of 24 hours of repeated administration of TS-071 in patient with type 2 diabetes mellitus.
♦Details of the study
Disease or condition Type 2 Diabetes Mellitus
Intervention
Intervention name TS-071
Classification name(code) of the intervention 396 (antidiabetic agents)
Dosage And administration of the intervention Oral
Control intervention name(code)/td> Placebo
Classification name(code) of the control intervention --- (other)
Dosage And administration of the control intervention Oral
Objectives of the study To assess the pharmacodynamics and safety
Study phase Phase 4
Study design Randomized, double blind, crossover study
Target sample size 40
Inclusion Criteria - Type 2 diabetes mellitus

etc.

AgeF     20years old or more
SexF     Both
Exclusion Criteria - Having non-type 2 diabetes mellitus.
- Having critical Heart Disease, other ciruculatory disease, cerebrovascular disorder, pancreatic disease and hematologic disease.

etc.

Outcome
Primary Outcome Blood glucose(CGM)
Timepoints
Secondary Outcome Adverse event
Timepoints
Institutions
Duration of the study 2014-5-8  ` 
Study status Study Completed
recruitment status Study Completed
Region Japan
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Taisho Pharmaceutical Co., Ltd
Division Clinical Research
Contact person or e-mail address etc. Clinical-trials@so.taisho.co.jp
Organization@(Scientific) Taisho Pharmaceutical Co., Ltd
Division@(Scientific) Clinical Research
Contact person or e-mail address etc.@(Scientific) Clinical-trials@so.taisho.co.jp
♦Other
Source funded
Name of research funds
Other
♦History
History
2016/4/22   revised
2015/3/12   revised
2014/6/30   revised
2014/5/27   application date