UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficiency and safety of dapagliflozin in treating of type 2 diabetes mellitus
Title of the study (Brief title)	Efficiency and safety of dapagliflozin
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of the improvement of blood glucose levels and safety by dapagliflozin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in HbA1c after administration 24 weeks later
Key secondary outcomes	Body weight Blood pressure Serum lipid heart function (LVEF, E/A, E/e', DcT, LVMI,LAV) Urinary albumin excretion Urinary L-FABP excretion, serum cystatinC,eGFR Liver function(AST,ALT,gammaGTP)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Men and women who were diagnosed with type 2 diabetes mellitus. Patients who are considered treatment with dapagliflozin is suitable. Patients with hypertention and/or abnormal electrocardiographic pattern. eGFR 45 ml/min/1.73 m2 <=
Key exclusion criteria	1.Type 1 diabetes mellitus 2.Diabetic ketoacidosis, diabetic coma, or before coma 3.Sever infection, before and not long after surgery, or patients with sever trauma 4.Left ventricular dysfunction (EF < 50%) 5.Sever liver dysfunction 6.Past history of cerebral infarction, myocardial infarction, and sever heart failure 7.Women suspected of pregnancy or pregnant 8.Patients with a history of use SGLT2 inhibitors 9.Patients who have repeated urinary tract infections 10.Alchole intake excessive 11.Inadequate patients judged by doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Hajime M. Koyano
Organization	Juntendo University Urayasu Hospital
Division name	Endocrinology and Diabetes
Address	2-1-1 Tomioka, Urayasu-city, Chiba, Japan
TEL	047-353-3111
Email	koyano@juntendo-urayasu.jp

Public contact
Name of contact person	Hajime M. Koyano
Organization	Juntendo University Urayasu Hospital
Division name	Endocrinology and Diabetes
Address	2-1-1 Tomioka, Urayasu-city, Chiba, Japan
TEL	047-353-3111
Homepage URL
Email	koyano@juntendo-urayasu.jp

Sponsor
Institute	Juntendo University Urayasu Hospital
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	順天堂大学医学部附属浦安病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 20 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	We clarify the effect of the improvement of blood glucose levels and safety by dapagliflozin.

Management information
Registered date	2016 Year 08 Month 19 Day
Last modified on	2019 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026561