UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of repaglinide on glycemic control in diabetic patients with chronic renal failure [Diamond study-2]
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masanori Emoto
Organization	Osaka City University Graduate School of Medicine
Division name	2nd department of internal medicine
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	Katsuhito Mori
Organization	Osaka City University Graduate School of Medicine
Division name	2nd department of internal medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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