UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018445 |
|---|---|
| Receipt number | R000021357 |
| Scientific Title | Efficacy and safety of DPP-4 inhibitors in diabetic patients undergoing hemodialysis |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2015/07/29 10:50:13 |
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Basic information
Public title
Efficacy and safety of DPP-4 inhibitors in diabetic patients undergoing hemodialysis
Acronym
DPP-4 inhibitors in diabetic patients on HD
Scientific Title
Efficacy and safety of DPP-4 inhibitors in diabetic patients undergoing hemodialysis
Scientific Title:Acronym
DPP-4 inhibitors in diabetic patients on HD
Region
| Japan |
Condition
Condition
Diabetes patients with hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of DPP-4 inhibitors in type 2 diabetic patients undergoing hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in glyated albumin level by DPP-4 inhibitors for 24 weeks
Key secondary outcomes
Changes in glyated hemoglobin level and postprandial plasma glucose level by DPP-4 inhibitors, and safety profiles for 24 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP-4 inhibitor, saxagliptin 2.5 mg daily are added on the standard therapy for 24 weeks.Standard therapies are defined as insulin therapy, alpha-glucosidase inhibitors, meglitinides, or diet therapy.
Interventions/Control_2
Standard therapy excluding DPP-4 inhibitors: 1) Insulin therapy alone, 2) Insulin therapy with alpha-glucosidase inhibitor, 3) alpha-glucosidase inhibitors alone, 4) Meglitinide alone, 5) alpha-GI with meglitinide, 6) Diet therapy alone.
Observational period: for 24 weeks
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients undergoing hemodialysis more than 6 months, 2)Type 2 diabetes mellitus, 3) Glycated albumin level exceeding 20.0% during 8 consecutive weeks of daily administration of conventional therapy despite dietary therapy or other antidiabetic agents
Key exclusion criteria
1) Infectious disease, 2) Thyroid disease, 3) Malignant tumors, 4) Liver dysfunction, 5) Type 1 diabetes, 6)Treatment with steroids or immunosuppressant, 7) History of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months, 8) Currently hospitalization.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University Itabashi Hospital
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-chou, Itabshi-ku, Tokyo, Japan
TEL
03-3972-8111
mabe@med.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University Itabashi Hospital
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
TEL
03-3972-8111
Homepage URL
mabe@med.nihon-u.ac.jp
Sponsor or person
Institute
Keiai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yujin Clinic, Meirikai Chuo General Hospital, Yujin Oizumi Gakuen Clinic, KeiaiClinic, Yamato Royal Clinic
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
| 2015 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021357
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
