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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029288
Receipt No. R000033477
Scientific Title To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor: Omarigliptin and the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors for the treatment of type 2 diabetes
Date of disclosure of the study information 2017/09/29
Last modified on 2019/09/22

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Basic information
Public title To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor: Omarigliptin and the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors for the treatment of type 2 diabetes
Acronym To evaluate the efficacy of Omarigliptin and the differences between Omarigliptin and daily DPP-4 inhibitors
Scientific Title To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor: Omarigliptin and the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors for the treatment of type 2 diabetes
Scientific Title:Acronym To evaluate the efficacy of Omarigliptin and the differences between Omarigliptin and daily DPP-4 inhibitors
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 once-weekly DPP-4 inhibitor, Omarigliptin, and to discuss the differences between Omarigliptin and once or twice-daily 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 IRI are set to be measured at baseline, 3, 6, 9, 12 months.
Key secondary outcomes Body mas index (BMI), blood pressure, albumin-creatinine ratio (ACR), lipid and liver function are set to be measured at baseline, 3, 6, 9, 12 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Active treatment with Omarigliptin 25mg once-weekly for 12 months
Interventions/Control_2
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 Type 2 diabetic patients
Key exclusion criteria 1)eGFR<30
2)Having had side effects of another DPP-4inhibitors before
Target sample size 50

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 Diabetes Internal Medicine
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 Diabetes Internal Medicine
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 Diabetes Internal Medicine, 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 Thoto clinic
Address 1-4 Kioi-cho Chiyoda-ku Tokyo
Tel 03-3229-0301
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
2017 Year 09 Month 29 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 50
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
2017 Year 08 Month 21 Day
Date of IRB
2016 Year 02 Month 25 Day
Anticipated trial start date
2017 Year 09 Month 29 Day
Last follow-up date
2019 Year 10 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
2017 Year 09 Month 25 Day
Last modified on
2019 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033477

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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