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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009166
Receipt No. 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

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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
Email 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
Email ktmori@med-osaka-cu.ac.jp

Sponsor
Institute Diamond study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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