UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006024 |
|---|---|
| Receipt number | 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 15:55:40 |
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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
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
Sponsor or person
Institute
Chibune general hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
