UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-
Title of the study (Brief title)	Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM
Region	Japan

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

Objectives
Narrative objectives1	To compare the effect of DPP-4 Inhibitors and Dapagliflozin using CGM in patients with type 2 diabetes treating with insulin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Mean Amplitude of glycemic excursions: MAGE
Key secondary outcomes	1) M-value 2) glucose area under the curve (over 180mg/dl and below 70mg/dl) 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure 8)multiple regression analysis 9)insulin dose

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sitagliptin Vildagliptin Teneligliptin Linagliptin Alogliptin Saxagliptin
Interventions/Control_2	Dapagliflozin
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 type 2 diabetes treating in combination with Inslin and DPP-4 inhibitors 2) HbA1c 6.0-9.0% 3) written informed consent
Key exclusion criteria	1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of drugs we use, 3) pregnancy, 4) lower than 45ml/min of eGFR, 5)lower Body mass index than 22kg/m2 6) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size	36

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	hidemiyoshi2003@yahoo.co.jp

Public contact
Name of contact person	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hidemiyoshi2003@yahoo.co.jp

Sponsor
Institute	Hokkaido University 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

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 31 Day
Anticipated trial start date	2014 Year 09 Month 07 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-017-0255-8
Results
Other related information

Management information
Registered date	2014 Year 09 Month 02 Day
Last modified on	2017 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017489