UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012206 |
|---|---|
| Receipt number | R000014274 |
| Scientific Title | Evaluation of blood glucose and serum lipids lowring effects of teneligliptin in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2017/09/05 20:12:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of blood glucose and serum lipids lowring effects of teneligliptin in patients with type 2 diabetes mellitus
Acronym
Effects of teneligliptin on blood glucose and serum lipids profile
Scientific Title
Evaluation of blood glucose and serum lipids lowring effects of teneligliptin in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effects of teneligliptin on blood glucose and serum lipids profile
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of blood glucose and serum lipids lowring effects of trneligliptin in patients with type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, LDL-c
Key secondary outcomes
HbA1c, blood glucose, u-Na, s-Na, s-Cr, u-Cr, NT-proBNP, IRI, ANP, sLDL, metylglyoxal, CRP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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 per day for 12weeks
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 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1:Patient with written concent for participation in this study
2:male and female
3:20 y.o or older
4:in- and out-patient
Key exclusion criteria
1:contrandication to teneligliptin
2:Ineligible for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ariyasu |
Organization
Wakayama medical University
Division name
First department of internal medicine
Zip code
Address
811-1, KImiidera, Wakayama, Japan, 641-8509
TEL
073(447)2300
ariyasu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ariyasu |
Organization
Wakayama medical University
Division name
First department of internal medicine
Zip code
Address
811-1, KImiidera, Wakayama, Japan, 641-8509
TEL
073(447)2300
Homepage URL
ariyasu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical University
Institute
Department
Personal name
Funding Source
Organization
First department of internal medicine, WAkayama Medical University
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 | 11 | Month | 05 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 04 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014274
