UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010343
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.