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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024001
Receipt No. R000027609
Scientific Title A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes
Date of disclosure of the study information 2016/09/12
Last modified on 2019/04/17

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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


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