UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012508 |
|---|---|
| Receipt number | R000014537 |
| Scientific Title | Teneligliptin effects on DPP-4 and glucagon concentrations in the serum during a meal test in patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/12/06 |
| Last modified on | 2018/12/10 09:04:30 |
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Basic information
Public title
Teneligliptin effects on DPP-4 and glucagon concentrations in the serum during a meal test in patients with type 2 diabetes
Acronym
TENDERNESS
Scientific Title
Teneligliptin effects on DPP-4 and glucagon concentrations in the serum during a meal test in patients with type 2 diabetes
Scientific Title:Acronym
TENDERNESS
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of teneligliptin on serum soluble CD26/DPP-4 levels, DPP-4 acitivity, and plasma glucagon after ingestion of a test meal in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial serum soluble CD26/DPP-4 levels, DPP-4 activity, and plasma glucose
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
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 20 mg/day
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 give written informed consent.
2.Outpatients
3.Patients who are on dieting and exercise therapy more than 12 weeks.
4.Patients whose HbA1c between 6.9% and 10.4%.
5.Difference in HbA1c between the starting day and last visit (4 weeks ago).
6. Patients with no history of receiving DPP-4 inhibitors.
7.Patients with FPG less than 180 mg/dl and HOMA-IR more than 2.0
Key exclusion criteria
1.Patients who have type 1 diabetes and/or secondary diabetes (Cushing syndrome or acromegaly).
2.Contraindication for DPP-4 inhibitors
3.Patients who have heart failure (NYHA category 3-4)
4.Patients who are prone to QT prolongation.
5 Alcohol intake excess.
6.Patients who are pregnant or may be pregnant
7.History of myocardial infarction
8.Patients who have received GLP-1 receptor agonists
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
Homepage URL
yaso@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism,Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Metabolism,Dokkyo 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 | 12 | Month | 06 | 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 | 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 | 12 | Month | 06 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014537
