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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038459
Receipt No. R000043558
Scientific Title To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Date of disclosure of the study information 2019/11/01
Last modified on 2019/11/01

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Basic information
Public title To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Acronym To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Scientific Title To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Scientific Title:Acronym To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of sitagliptin for 10 years and to discuss the differences between using sitagliptin and unusing DPP-4 inhibitors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fasting blood glucose and HbA1c are set to be measured at baseline and once at 3 months for 10 years.
Key secondary outcomes Body Mass Index (BMI), blood pressure, albumine creatinine ratio (ACR), lipid and liver function are set to be measured at baseline and once at 3 months for 10 years.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Active treatment with sitagliptin 50mg/day for 10 years
Interventions/Control_2 Active treatment except all of DPP-4 inhibitors for 10 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetes
2) eGFR over 30ml/min/1.73m2
3) Diet end exercise are well performed
4) Understanding of the study procedures and consenting to it by signatures
Key exclusion criteria 1) Pregnant or being pregnant within the study
2) Contraindication with sitagliptin
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Sachiko
Middle name
Last name Hattori
Organization Foundation Health Medicine Association Tohto Clinic
Division name Department of Diabetes and Metabolism
Zip code 102-0094
Address 4-1 Kioi-Cho, Chiyoda-Ku, Tokyo, 102-0094, Japan
TEL 03-3239-0301
Email s-hattori@kenkoigaku.or.jp

Public contact
Name of contact person
1st name Sachiko
Middle name
Last name Hattori
Organization Foundation Health Medicine Association Tohto Clinic
Division name Department of Diabetes and Metabolism
Zip code 102-0094
Address 4-1 Kioi-Cho, Chiyoda-Ku, Tokyo, 102-0094, Japan
TEL 03-3239-0301
Homepage URL
Email s-hattori@kenkoigaku.or.jp

Sponsor
Institute Department of Diabetes and Metabolism,Tohto Clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization REC, Tohto Clinic
Address 4-1, Kioi-Cho, Chiyoda-Ku, Tokyo
Tel 03-3239-0301
Email s-hattori@kenkoigaku.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2008 Year 10 Month 03 Day
Date of IRB
2019 Year 10 Month 08 Day
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043558

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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