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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006024
Receipt No. R000007128
Scientific Title Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Date of disclosure of the study information 2011/07/25
Last modified on 2017/01/24

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Basic information
Public title Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Acronym Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Scientific Title Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Scientific Title:Acronym Effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis
Region
Japan

Condition
Condition Type 2 diabetic patients on hemodialysis
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The investigation of the effect of dipeptidyl peptidase-4 inhibitor to the additional secretion of insulin in type 2 diabetic patients on hemodialysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in levels of HbA1c(JDS), glycoalbumin, plasma glucose along with the comparison of the results obtained from glucagon load test and 75g oral glucose tolerance test after 12weeks treatment from the baseline.
Key secondary outcomes Changes in serum levels of inflammatory markers, body weight, body fat percentage, skeletal muscle mass measured with In Body S20.

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 Observation span : 12 weeks
Intervention : Vildagliptin (Equa)
Dose : 50mg once daily for a week after starting and 50mg twice daily after 2weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients on hemodialysis with only dietary therapy who showed HbA1c(JDS) <8.0% and postprandial glucose concentration >180mg/dl
Key exclusion criteria (1)Type 2 diabetic patients who received insulin therapy or oral hypoglycemic agents or Liraglutide.
(2) Type 2 diabetic patients who have been treated with DPP-4 inhibitor.
(3) Type 1 diabetic patients.
(4) Patients who develop serious hyperglycemia or diabetic ketoacidosis.
(5) Patients with nephrotic syndrome.
(6) Patients with treatments of steroids or immunosuppressive agents or antifungal or HIV protease inhibitors.
(7) Patients with severe complications in cardiovascular system within 6 months before study entry.
(8) Patients with liver diseases.
(9) Patients with cancer diseases.
(10) Patients with pregnancy , possibility of pregnancy .
(11) Patients who are deemed to be inappropriate by the investigators.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Tamori
Organization Chibune general hospital
Division name Endocrinology and Metabolism
Zip code
Address 2-2-45 Tsukuda, Nisiyodogawa-ku, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sachie Hirose
Organization Chibune general hospital
Division name Nephrology
Zip code
Address 2-2-45 Tsukuda, Nisiyodogawa-ku, Osaka, Japan
TEL 06-6471-9541
Homepage URL
Email

Sponsor
Institute Chibune general hospital
Institute
Department

Funding Source
Organization Chibune general hospital
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
2011 Year 07 Month 25 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 Enrolling by invitation
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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
2011 Year 07 Month 22 Day
Last modified on
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007128

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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