UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009166 |
|---|---|
| Receipt number | R000010701 |
| Scientific Title | Efficacy and safety of repaglinide on glycemic control in diabetic patients with chronic renal failure [Diamond study-2] |
| Date of disclosure of the study information | 2012/10/23 |
| Last modified on | 2016/04/30 17:00:06 |
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Basic information
Public title
Efficacy and safety of repaglinide on glycemic control in diabetic patients with chronic renal failure [Diamond study-2]
Acronym
Efficacy of repaglinide in diabetic patients with chronic renal failure [Diamond study-2]
Scientific Title
Efficacy and safety of repaglinide on glycemic control in diabetic patients with chronic renal failure [Diamond study-2]
Scientific Title:Acronym
Efficacy of repaglinide in diabetic patients with chronic renal failure [Diamond study-2]
Region
| Japan |
Condition
Condition
Diabetic patients with chronic renal failure
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of repaglinide on glycemic control in diabetic patients with chronic renal failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline to week 12 in HbA1c
Key secondary outcomes
Change from baseline to week 12 in glycated albumin
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
repaglinide
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
Patients who meet the following requirements [both 1) and 2)]
1) Patients with chronic renal failure who have serum creatinine >= 1.5mg/dL or eGFR < 60mL/min/1.73m2 (except patients on dialysis)
2) Patients with type 2 diabetes mellitus who have HbA1c (NGSP) >= 6.5% and <= 10.0% or glycated albumin >= 18.0% and <= 30.0%
Key exclusion criteria
Patients with severe liver dysfunction (AST >= 100 IU/L or ALT >= 100 IU/L)
Patients with malignancy under medical treatment
Patients with untreated diabetic retinopathy
Patients disqualified by doctor for any reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Emoto |
Organization
Osaka City University Graduate School of Medicine
Division name
2nd department of internal medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3806
memoto@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhito Mori |
Organization
Osaka City University Graduate School of Medicine
Division name
2nd department of internal medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3806
Homepage URL
ktmori@med-osaka-cu.ac.jp
Sponsor or person
Institute
Diamond study group
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
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
| 2012 | Year | 10 | Month | 23 | 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
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 25 | 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
| 2012 | Year | 10 | Month | 22 | Day |
Last modified on
| 2016 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010701
