UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016072 |
|---|---|
| Receipt number | R000018674 |
| Scientific Title | The renoprotective effect and safety of a DPP-4 inhibitor, Sitagliptin, in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors |
| Date of disclosure of the study information | 2014/12/29 |
| Last modified on | 2019/04/15 15:50:10 |
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Basic information
Public title
The renoprotective effect and safety of a DPP-4 inhibitor, Sitagliptin, in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors
Acronym
REAL Trial
Scientific Title
The renoprotective effect and safety of a DPP-4 inhibitor, Sitagliptin, in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors
Scientific Title:Acronym
REAL Trial
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japanese type 2 diabetic patients with moderate or severe renal impairment, we evaluated the maintenance and protection of renal function by DPP4 inhibitor, sitagliptin, and further to explore effective glycemic control treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal function (changes in eGFRcreat, eGFRcys, serum creatinie, and cystatin C)
renoprotection (changes in urinary L-FABP, urinary albumin creatinine ratio, urinary type IV collagen, urinary 8- isoprostane, urinary beta 2 microgloburin, h-CRP)
Key secondary outcomes
glycemic control (changes in HbA1c, postprandial blood glucose level)
lipid (changes in LDL-cholesterol, TG, HDL-cholesterol)
changes in blood pressure, NT pro-BNP, ANP
changes in active GLP-1, insulin levels, C- peptide
changes in body weight
changes in other laboratory values
stratified analysis : prior medication, complications, blood glucose level, BMI, diabetes history, age
safety assessment : incidence of adverse events, deterioration of renal function, and hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Depending on the degree of renal function, we intervene as following.
Group A (eGFR 30-59 mL / min / 1.73m2): sitagliptin 25mg
Interventions/Control_2
Group B (eGFR less than 30 mL / min / 1.73m2): sitagliptin 12.5mg
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 with moderate or severe renal dysfunction (*1) (including end-stage renal failure patients)
(*1 eGFR less than 60mL/min/1.73m2)
2) Patients with type 2 diabetes during treatment more than two months, in combination with DPP4 inhibitors other than sitagliptin (*2) or the DPP4 inhibitors inclusive other antidiabetics (*3)
(*2 vildagliptin 50-100mg alogliptin 6.25-12.5mg linagliptin 5mg
(*3 sulfonylureas, alfa-GIs, thiazolidines, insulins)
3) HbA1c of 6.0% or more, and less than 9.0%
4) Patient consent was obtained by document
Key exclusion criteria
1) Patients with severe ketosis, or history of diabetic coma or precoma, within the past 6 months
2) Patients with severe infection, or before and after surgery, or severe trauma
3) Patients in pregnant or might be pregnant women or in nursing
4) Patients are prescribed biguanides or glinides or GLP-1 analogs
5) Patients with a history of hypersensitivity to DPP4 inhibitors
6) Patients who have been determined to be inappropriate for research participation by the attending physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiro Katayama |
Organization
Saitama Medical University
Division name
Division of Endocrinology and Diabetes, Department of Medicine
Zip code
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama 350-0495, Japan
TEL
049-276-1104
skataya@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Kanozawa |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Nephrology and Hypertension
Zip code
Address
1981, Kamoda, Kawagoe, Saitama 350-8550 JAPAN
TEL
049-228-3604
Homepage URL
kanozawa@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10157-017-1521-7
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
| 2014 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018674
| Research Plan | |
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| 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 |
