UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003661 |
|---|---|
| Receipt number | R000004433 |
| Scientific Title | Efficacy of vildagliptin monotherapy on glycemic control in type 2 diabetic patients on hemodialysis. |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2011/03/16 09:42:24 |
* 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
Efficacy of vildagliptin monotherapy on glycemic control in type 2 diabetic patients on hemodialysis.
Acronym
Efficacy of vildagliptin monotherapy on glycemic control in type 2 diabetic patients on hemodialysis.
Scientific Title
Efficacy of vildagliptin monotherapy on glycemic control in type 2 diabetic patients on hemodialysis.
Scientific Title:Acronym
Efficacy of vildagliptin monotherapy on glycemic control in type 2 diabetic patients on hemodialysis.
Region
| Japan |
Condition
Condition
Type 2 diabetic patients on hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluatuions of efficacy and safety of vildagliptin on glycemic control in type 2 diabetic patients on hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Changes in levels of HbA1c, glycated albumin, soluble insulin receptor, glucagon and blood glucose. (2, 4, 8, 12, 16, 20 and 24 weeks after starting of treatment)
Key secondary outcomes
Changes in serum levels of inflammatory markers. (12 and 24 weeks after starting of treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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: 24 weeks
Intervention: Vildagliptin (Equa)
Dose: 50mg once daily
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
Type 2 diabetic patients on hemodialysis, treated with diet and exercise alone or oral anti-diabetic agents.
Key exclusion criteria
1) Type 1 diabetic patients
2) Type 2 diabetic patients with insulin theapy
3) Patients with liver disease
4) Patients with cancer disease
5) Patients with inflammatory disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Uzu |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Seta, Otsu, Shiga, Japan
TEL
077-548-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Kume |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Seta, Otsu, Shiga, Japan
TEL
077-548-2222
Homepage URL
skume@belle.shiga-med.ac.jp
Sponsor or person
Institute
Hiroshi Maegawa
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
| 2010 | Year | 06 | Month | 01 | 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
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 25 | Day |
Last modified on
| 2011 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004433
