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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012120
Receipt No. 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

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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
Email 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
Email s-toyoda@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014161

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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