UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM)
Title of the study (Brief title)	A randomized and comparative study of DPP4 inhibitors versus SGLT2 inhibitors using cotinuous glucose monitoring (CGM)
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 purpose of this study is to investigate the effect of SGLT2 inhibitors or DPP4 inhibitors on glycemic control and safty in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	SD of blood glucose by CGM
Key secondary outcomes	1)averate blood glucose, MAGE by CGM 2)FPG and PPG at 1, 2, 3, 4, 5, 6, 7 days of treatment 3)%chagne of FPG, HbA1c,IRI,CPR, a from baseline 4)a questionnaire survey

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SGLT2 inhibitors: This study to examine the change in SD of 24h and MAGE by CGM,blood glucose levels,Body weight,urine volume before and after the start.
Interventions/Control_2	DPP-4 inhibitors: This study to examine the change in SD of 24h and MAGE by CGM,blood glucose levels,Body weight,urine volume before and after the start.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)before test registration - the meal and exercise cure for one month or more or a meal and an exercise cure, and diabetic medicine and inpatient 2)HbA1c(NGSP):more than 7.0%, less than 14.0% 3)126mg/dl<=FPG<250mg/dl and 200mg/dl<=PPG<350mg/dl 4)eGFR more than 45ml/min/1.73m 2 5)Type 2 diabetes 6)Pts with written IC 7)Age more than 20, less than 85
Key exclusion criteria	1)severe ketosis, diabetic coma within 6 months 2)severe infection, before operation, severe trauma 3)severe hepatic dysfunction 4)or severe renal dysfunction (Cr: more than 1.5mg/dl) 5)Patients who use of insulin 6)pregnacy 7)Allergy for sitagliptin, nateglinide,liraglutide and exenatide 8)Patients judged by the investigator to be ineligible for some other reason
Target sample size	20

Research contact person
Name of lead principal investigator	Tadashi Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	naibunpi@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Joe Nagakura
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	jo0806nagakura@hotmail.com

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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	横浜市立大学附属市民総合医療センター（神奈川県） 横須賀市立市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 08 Day
Anticipated trial start date	2014 Year 09 Month 08 Day
Last follow-up date	2016 Year 02 Month 01 Day
Date of closure to data entry	2016 Year 02 Month 01 Day
Date trial data considered complete	2016 Year 03 Month 01 Day
Date analysis concluded	2016 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/endocrj/63/3/63_EJ15-0500/_article
Results
Other related information

Management information
Registered date	2014 Year 09 Month 08 Day
Last modified on	2017 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017547