UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus
Title of the study (Brief title)	The Sodium glucose transporter 2 inhibitor with acute insulin treatment for controlling severe hyperglycemia in patients with type 2 Diabetes mellitus
Region	Japan

Condition
Condition	type2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the effectiveness and safety of the SGLT2 inhibitor with acute insulin treatment in type2 diabetes mellitus patient who need insulin to resolve severe-hyperglycemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.the dose of insulin and treatment period to manage hyperglycemia 2.measurement of energy expenditure and respiratory quotient by using the indirectcalorimetry
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	insulin treatment adding 5mg Dapagliflozin for 1 week.the attending physician dose of insuline adjusted according to the algorithm
Interventions/Control_2	insulin treatment not adding Dapagliflozin for 1 week. the attending physician dose of insuline adjusted according to the algorithm
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients with HbA1c over 10% (2) Patients who does not use human GLP-1 analog or insulin (3) Adalts who are 20 years or older (4) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria	(1) Type 1 diabetes mellitus patients or secondary diabetic mellitus (2) Patients who had myocardial infarction within 3 months, or obvious heart failure case (3) Patients who had the past of hypersensitivity for the used drug (4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma (5) Patients with severe liver disease (6) Patients with severe renal disease (7) Patients with severe pancreas disease (8) Patients with hemoglobin (Hb) less than 11 g/dL (9) Patient during cancer treatment (10) Patients that the number of the platelets is less than 100,000 /mm3 (11) Patients with high diabetic neuropathy (12) Patients having a proliferative retinopathy (13) Patients with a serious infectious disease or a serious injury (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant (16) In addition, the patient who judged inappropriate by an attendant physician
Target sample size	20

Research contact person
Name of lead principal investigator	Uchino hiroshi
Organization	Toho University School of Medicine
Division name	Divsion of diabetes, metabolism and endocrinology
Address	6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Email	h.uchino@med.toho-u.ac.jp

Public contact
Name of contact person	Uchino hiroshi
Organization	Toho University School of Medicine
Division name	Divsion of diabetes, metabolism and endocrinology
Address	6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Homepage URL
Email	h.uchino@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine,Divsion of diabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization	Toho University School of Medicine
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	2015 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 08 Day
Last follow-up date	2015 Year 11 Month 24 Day
Date of closure to data entry	2016 Year 06 Month 13 Day
Date trial data considered complete	2016 Year 06 Month 13 Day
Date analysis concluded	2016 Year 06 Month 13 Day

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

Management information
Registered date	2015 Year 09 Month 13 Day
Last modified on	2016 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021333