UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical study to explore the effects of sodium-dependent glucose co-transporter 2 inhibitors on responses of orexigenic hormone 'ghrelin' in patients with type 2 diabetes
Title of the study (Brief title)	Effects of SGLT2 inhibitors on ghrelin secretion in patients with type 2 diabetes
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on plasma ghrelin level in patients with type 2 diabetes mellitus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	changes in plasma ghrelin level before and after 2-week administration of SGLT2 inhibitors
Key secondary outcomes	changes in glycated albumin,glucagon, leptin, growth hormone, insulin-like growth factor-1, antidiuretic hormone, LDL-cholesterol, HDL-cholesterol,C-peptide immunoreactivity, sodium, body composition, body weight, blood pressure, frequency scale for symptoms of gastroesophageal reflux disease and visual analogue sacle for appetite before and after 2-week administration of SGLT2 inhibitors

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	sodium-dependent glucose co-transporter 2 inhibitors(SGLT2 inhibitors)
Interventions/Control_2	insulin or its analogues and oral hypoglycemic agents
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)patients with type 2 diabetes mellitus 2)ability to provide written informed consent for this study 3)inpatients 4)HbA1c>=7.0% 3)patients without change of treatment for the past 28 days
Key exclusion criteria	1)Body Mass Index <22 2)an excessive alcohol drunker 3)patients who were added same drugs during the course of the trial 4)patients with severe ketosis, diabetic coma or precoma 5)patients with hepatic dysfunction(child-pugh B or worse) or severe renal dysfunction(eGFR<50) 6)patients with severe infection, perioperative period or severe injury 7)patients with allergy for SGLT2 inhibitors 8)patients with a history of gastrointestinal tract surgery 9)pregnant women or women that may have become pregnant 10)patients determined to be inappropriate by physician
Target sample size	60

Research contact person
Name of lead principal investigator	Akamizu Takashi
Organization	Wakayama medical university
Division name	The first department of medicine
Address	811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL	073-461-0625
Email	akamizu@wakayama-med.ac.jp

Public contact
Name of contact person	Takayuki Ota
Organization	Wakayama medical university
Division name	The first department of medicine
Address	811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL	073-461-0625
Homepage URL
Email	tota@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university, the first department of medicine
Institute
Department

Funding Source
Organization	Wakayama medical university, the first department 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	和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 06 Month 02 Day
Anticipated trial start date	2014 Year 06 Month 16 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 06 Month 10 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016569