UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema
Title of the study (Brief title)	Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema
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 compare the efficacy and safety of SGLT2 inhibitors(Canagliflozin) and DPP-4 ihhibitors(Sitagliptin) in patients with diabetic macular edema
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Mean change from baseline in retinal central foveal thickness using optical coherence tomography (OCT)
Key secondary outcomes	1)Mean change at 3 months and 2 years after administration of canagliflozin or sitagliptin Glucose HbA1c Body weight Lipid Blood pressure Endo-PAT 2) Number of times that were treated with anti-VEGF drugs in 2 years

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Canagliflozin 100mg/day for 3months
Interventions/Control_2	Sitagliptin 50mg/day for 3months
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	65 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)eGFR more than 45ml/min/1.73m 2 4)Type 2 diabetes 5)Pts with written IC 6)Age more than 20, less than 65 7)Diabetic macular edema
Key exclusion criteria	1)Patients treated with photocoagulation, anti-VEGF drugs or steroids to intraocular within 6 months 2)severe ketosis, diabetic coma within 6 months 3)severe infection, before operation, severe trauma 4)severe hepatic dysfunction 5)Patients who use of insulin, GLP-1 receptor agonist or diuretic 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	30

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）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 08 Day
Anticipated trial start date	2014 Year 12 Month 08 Day
Last follow-up date	2017 Year 03 Month 30 Day
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 12 Month 08 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018468