UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010343 |
|---|---|
| Receipt number | R000012104 |
| Scientific Title | Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2015/03/31 13:20:12 |
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Basic information
Public title
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Acronym
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Scientific Title
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Scientific Title:Acronym
Evaluation of pharmacodynamics and safety of teneligliptin in type 2 diabetic patients with chronic renal dysfunction
Region
| Japan |
Condition
Condition
Patients with Type 2 diabetes [chronic renal dysfunction (CKD Stage:over G3b)]
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of teneligliptin 20 mg, single and repeated administration, on plasma teneligliptin concentration and response of c-peptide and incretin to the meal test in type 2 diabetic patients with chronic renal dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration of teneligliptin
Changes in active GLP-1 levels
Key secondary outcomes
C-peptide- and glucagon-response to the meal test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 1week
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 agreed to participate in this study with a written consent
2) Gender: agnostic
3) Age: 20 years old or older when obtaining consent
4) Inpatient and outpatient: hospitalization
5) 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.
6) CKD stage over G3b based on serum Cystatin C level within four weeks of day1.
Key exclusion criteria
1)Type 1 diabetes,diabetes arising from the failure of pancreas,or secondary diabetes (eg. Cushing's syndrome and acromegaly)
2) Patient correspond to contraindications of teneligliptin
3) Excessive alcohol addicts: patient who take average net more than 60 g alcohol every single day (more than following: 3 bottles of sake, 1 with shochu, 3 bottles of beer, 3 glasses of whiskey or brandy(double),and 5 glasses of wine)
4) Pregnant, lactating, possible pregnant patient
5) Patient judged as ineligible for this study by the researcher
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hamamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ogimachi, Kita-ku, Osaka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
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 | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012104
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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