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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029551
Receipt No. R000033712
Scientific Title Expectation of cutting down of medical bills by administering half-dose sitagliptin
Date of disclosure of the study information 2017/10/16
Last modified on 2018/10/29

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Basic information
Public title Expectation of cutting down of medical bills by administering half-dose sitagliptin
Acronym Expectation of cutting down of medical bills by administering half-dose sitagliptin
Scientific Title Expectation of cutting down of medical bills by administering half-dose sitagliptin
Scientific Title:Acronym Expectation of cutting down of medical bills by administering half-dose sitagliptin
Region
Japan

Condition
Condition Japanese patients with non-insulin dependent diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of HbA1c after reducing the dose of sitagliptin(50mg/day-25mg/day)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c
Key secondary outcomes Bady weight,1.5AG,C-peputide index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Reduction of dose of sitagliptin or not.
Interventions/Control_2 Standard dose of sitagliptin.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age 20 years<=
2. HbA1c <7.0%
3. eGFR 60mL/min/1.73m <=
4. Concomitant medicines is sitagliptin only or sitagliptin and metformin or sitagliptin and sulfonylurea or sitagliptin and metformin and sulfonylurea.
5. Under treatment with fixed diet and exercise.
6. Hb male 13.5-17.6g/dL female 11.3-15.2g/dL
Key exclusion criteria 1. AST or ALT rises morethan 3 times the reference value.
2. Patients who was considered to be difficult to take part in this trial by physician in change.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayako Yoshimoto
Organization Medical Corporation
H.E.C Science Clinic
Division name Diabetes internal medicine
Zip code
Address 4-1-4-102 Yokodai Isogo Yokohama Kangawa Japan
TEL 045-831-0031
Email hec@asahi-net.email.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Makuuchi
Organization Medical Corporation H.E.C Science Clinic
Division name Clinical Trial Secretariat
Zip code
Address 4-1-4-102 Yokodai Isogo Yokohama Kangawa Japan
TEL 045-831-0031
Homepage URL
Email hec@asahi-net.email.ne.jp

Sponsor
Institute Medical Corporation
H.E.C Science Clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団一洋会 H.E.Cサイエンスクリニック (神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 16 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 03 Month 30 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 14 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033712

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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