UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of dapagliflozin (sodium glucose cotransporter 2 inhibitor) to verify the efficacy of combination therapy in Japanese patients with type 2 diabetes
Title of the study (Brief title)	DISCOVERY study
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and the safety of SGLT2 inhibitor, dapaglifrozin, in patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change and percent change in HbA1c from baseline to 6 months Adverse events
Key secondary outcomes

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	Orally administration of 5 mg dapagliflozin once a day for 6 months
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age: >= 20 and <= 75 2) HbA1c: >= 7.0 and <= 10% 3) Change of HbA1c within 3 months prior to registration: <= +/-1%
Key exclusion criteria	1) type 1 diabetes 2) BMI: >= 45 3) patients suspected of pregnancy or pregnant or nursing 4) diabetes insipidus 5) severe liver dysfunction (liver cirrhosis, viral hepatitis, AST: >= 3 times of upper limit) 6) moderate renal dysfunction (eGFR: < 45 ml/min/1.73m2) 7) heart disease (myocardial infarction, unstable angina) or stroke within 3 months 8) considered as inadequate by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	JUN WADA
Organization	Okayama University Hospital
Division name	nephrology, diabates and endocrinology
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7235
Email	junwada@md.okayama-u.ac.jp

Public contact
Name of contact person	DAISUKE OGAWA
Organization	Okayama University Hospital
Division name	nephrology, diabates and endocrinology
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7235
Homepage URL
Email	daiogawa@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital nephrology, diabates and endocrinology
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)

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 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 27 Day
Anticipated trial start date	2014 Year 06 Month 24 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	2014 Year 10 Month 08 Day
Last modified on	2017 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017886