UMIN-CTR Clinical Trial

Basic information
Public title	A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes
Acronym	The effect of empagliflozin for endothelial function
Scientific Title	A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes
Scientific Title:Acronym	The effect of empagliflozin for endothelial function
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of empagliflozin for endothelial function in type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of FMD% with additional treatment before and after 12 weeks
Key secondary outcomes	1.Change of them with additional treatment before and after 12 weeks Fasting plasma glucose Postprandial plasma glucose HbA1c GA Fasting CPR Renal function Urinary albumin L-FABP UA Body weight Waist BMI Blood pressure Heart rate Lipid profile(TC, TG, HDL-C, LDL-C) Body domposition(Body fluid volume, Skeletal muscle mass, Total fat mass) 2.Adverese event

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin group: Metformin and glargine before bedtime for 12 weeks, then empagliflozin 10 mg was added for 12 weeks. FMD was measured before and after additional treatment.
Interventions/Control_2	Glimepiride group: Metformin and glargine before bedtime for 12 weeks, then glimepiride 0.5 mg was added for 12 weeks. FMD was measured before and after additional treatment.
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.Inpatients with Type 2 diabetes at Chigasaki municipal hospital 2.Patients treated with metformin and basal insulin in leaving hospital 3.Age lower limit 20, upper limit 80 4.BMI <= 45 kg/m2 5.Patients gave written consent to participate in this study
Key exclusion criteria	1.Patients with severe renal dysfunction (eGFR < 45 ml/min/1.73m2) 2.Patients with severe liver dysfunction 3.Patients have history of cardiovascular disease and cerebral infarction within 24 weeks 4.Patients taking steroid 5.Patients with cancer 6.Patients with severe infection and trauma 7.Patients are pregnant or have possibility of pregnancy 8.Patients have an allergy to empagliflozin, glimepiride, glargine and metformin 9.Patients considered inappropriate to participate in this study by the doctor in charge
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Shinobu Middle name Last name Satoh
Organization	Chigasaki Municipal Hospital
Division name	Division of Endocrinology & Metabolism
Zip code	2530042
Address	5-15-1, Honson, Chigasaki, Kanagawa
TEL	0467-52-1111
Email	shinobu@medical.email.ne.jp

Public contact
Name of contact person	1st name Haruka Middle name Last name Tamura
Organization	Chigasaki Municipal Hospital
Division name	Division of Endocrinology & Metabolism
Zip code	2530042
Address	5-15-1, Honson, Chigasaki, Kanagawa
TEL	0467-52-1111
Homepage URL
Email	t166054a@yokohama-cu.ac.jp

Sponsor
Institute	Chigasaki Municipal 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)

IRB Contact (For public release)
Organization	Chigasaki Municipal Hospital
Address	5-15-1, Honson, Chigasaki, Kanagawa
Tel	0467-52-1111
Email	shinobu@medical.email.ne.jp

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	茅ヶ崎市立病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 22 Day
Date of IRB	2016 Year 04 Month 22 Day
Anticipated trial start date	2016 Year 09 Month 13 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 10 Day
Last modified on	2019 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027609

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.