UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024001
Receipt number 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 2022/03/17 15:37:27

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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 or person

Institute

Chigasaki Municipal Hospital

Institute

Department

Personal name



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

Completed

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

2019 Year 06 Month 14 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

2022 Year 03 Month 17 Day



Link to view the page

Value
https://center6.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