UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012120 |
|---|---|
| Receipt number | R000014161 |
| Scientific Title | The effects of teneligliptin on cardiac function and endothelial function in patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2013/10/25 13:02:05 |
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Basic information
Public title
The effects of teneligliptin on cardiac function and endothelial function in patients with type 2 diabetes
Acronym
Efficacy of teneligliptin in patients with type 2 diabetes
Scientific Title
The effects of teneligliptin on cardiac function and endothelial function in patients with type 2 diabetes
Scientific Title:Acronym
Efficacy of teneligliptin in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of teneligliptin on cardiac function and endothelial function in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Glycosylated hemoglobin (HbA1c) levels over 24 weeks
Key secondary outcomes
Echocardiography, Endothelial function, Biomarker
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
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)Patients who continued diet and exercise therapy more than 12 weeks before day1. Exercise therapy is not essential if it is prohibited because of the complication
2)HbA1c levels of 6.9%<= to <10.4%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases
3)Difference in HbA1c levels <0.5% at the start date and 4 weeks before the start of administration
4)Insufficient in an effect except DPP-4 inhibitor
Key exclusion criteria
1)Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions such as Cushing's syndrome and acromegaly
2)Application of contraindications contained in the package insert
3)Heart failure (NYHA grade 3-4)
4)Patients prone to QT prolongation
5)Excessive alcohol consumption
6)Pregnant women, women suspected of being pregnant, or lactating women
7)History of myocardial infarction
8)The medication in the treatment of diabetes drugs not be used with insurance
9)Under administration of GLP-1 agonists
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruo Inoue |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
880 Kitakobayashi Mibu Tochigi
TEL
0282-86-1111
s-toyoda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Toyoda |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
880 Kitakobayashi Mibu Tochigi
TEL
0282-86-1111
Homepage URL
s-toyoda@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
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 | 28 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2013 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014161
