UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011847 |
|---|---|
| Receipt number | R000013847 |
| Scientific Title | Evaluation of the anticoagulant effect in Teneligliption in type 2 diabetic patients |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2023/05/30 13:49:48 |
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Basic information
Public title
Evaluation of the anticoagulant effect in Teneligliption in type 2 diabetic patients
Acronym
Evaluation of the anticoagulant effect in Teneligliption in type 2 diabetic patients
Scientific Title
Evaluation of the anticoagulant effect in Teneligliption in type 2 diabetic patients
Scientific Title:Acronym
Evaluation of the anticoagulant effect in Teneligliption in type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of DPP-4 inhibitor Teneligliptin on insulin, proinsulin, postprandial lipid and PAI-1 in patients with type 2 diabetes or abnormal glucose tolerance
"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, pre- and post-prandial(1,2hours)blood glucose, pre-and post-prandial(1,2hours)lipid, pre-and post-prandial(1,2hours)insulin, pre- and post-prandial(1,2hours)proinsulin, pre- and post-prandial(2hours)PAI-1
Key secondary outcomes
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
Teneligliptin 20mg/day for 6 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
"1)Type 2 diabetic who is enforcing dietary therapy and an exercise cure
"
"2)Patient who is not using DPP4 inhibitory drug more than 12 weeks before a medical treatment term opening day (84 days)
"
3)Patients with written IC
Key exclusion criteria
"1)Type I diabetes, the diabetes which arose according to the obstacle of the pancreas, or secondary diabetes patients (Cushing syndrome, tip hypertrophia, etc.)
"2)Patient who corresponds to contraindications with the package leaflet of Teneligliptin
"3)Patient with an excessive habitual drinking
4)Pregnant and breast-feeding
"5)Patients judged by the research responsibility (assignment) doctor to be ineligible for some other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Dept. of Endocrinology and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Dept. of Endocrinology and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
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
Address
Tel
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
| 2013 | Year | 10 | 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
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
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2013 | Year | 09 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013847
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
