UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029551 |
|---|---|
| Receipt number | 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 | 2020/01/10 14:14:24 |
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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 | Ayako |
| Middle name | |
| Last name | Yoshimoto |
Organization
Medical Corporation
H.E.C Science Clinic
Division name
Diabetes internal medicine
Zip code
235-0045
Address
4-1-4-102 Yokodai Isogo Yokohama Kangawa Japan
TEL
045-831-0031
hec@asahi-net.email.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Makuuchi |
Organization
Medical Corporation H.E.C Science Clinic
Division name
Clinical Trial Secretariat
Zip code
235-0045
Address
4-1-4-102 Yokodai Isogo Yokohama Kangawa Japan
TEL
045-831-0031
Homepage URL
hec@asahi-net.email.ne.jp
Sponsor or person
Institute
Medical Corporation
H.E.C Science Clinic
Institute
Department
Personal name
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
Ethics review committee of Medical Corporation H.E.C Science Clinic
Address
4-1-4-102 Yokodai Isogo Yokohama Kangawa Japan
Tel
045-831-0031
hec-soum@asahi-net.email.ne.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
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
30
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
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
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033712
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
