UMIN-CTR Clinical Trial

Basic information
Public title	Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]
Acronym	Effects of dapagliflozin on renal function [Diamond study-4]
Scientific Title	Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]
Scientific Title:Acronym	Effects of dapagliflozin on renal function [Diamond study-4]
Region	Japan

Condition
Condition	patients with type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of dapagliflozin on glomerular filtration rate (GFR)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes from baseline to day 5-9 in GFR evaluated by inulin clearance
Key secondary outcomes	Changes from baseline to month 6-12 in hepatic fat amount

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	dapagliflozin
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following requirements. 1. Patients with type 2 diabetes and HbA1c more than 6.5% 2. Estimated GFR more than 45 mL/min 1.73m2 3. Patients who provide their consent form
Key exclusion criteria	Patients who meet one of the following criteria are ecluded. 1. Patients treated with insulin 2. Patients with unstable angina 3. Patients with severe liver dysfunction (AST >= 100IU/L or ALT >= 100IU/L) 4. Patients with severe renal dysfunction (eGFR < 45 mL/min/1.73m2) 5. Known hypersensitivity to dapagliflozin 6. Patients who are pregnant, possibly pregnant, or nursing 7. A history of traetment with SGLT2 inhibitors including dapagliflozin 8. Patients disqualified by doctor for any reason
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuhito Mori
Organization	Osaka City Graduate School of Medicine
Division name	Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-3806
Email	ktmori@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Katsuhito Mori
Organization	Osaka City Graduate School of Medicine
Division name	Department of Metabolism, Endocrinology and Molecular 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	2015 Year 12 Month 14 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	2015 Year 12 Month 07 Day
Date of IRB	2015 Year 12 Month 07 Day
Anticipated trial start date	2015 Year 12 Month 14 Day
Last follow-up date	2018 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 12 Month 14 Day
Last modified on	2019 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023297