UMIN-CTR Clinical Trial

Public title

Clinical effects of empagliflozin dose increase in patients with type 2 diabetes: a retrospective observational study

Acronym

CLENDEIN study

Scientific Title

Clinical effects of empagliflozin dose increase in patients with type 2 diabetes: a retrospective observational study

Scientific Title:Acronym

CLENDEIN study

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the clinical effect of dose increase of empagliflozin in patients with type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparing the change in HbA1c between before and after dose-increasing of empagliflozin.

Key secondary outcomes

1: Comparing the change in body weight between before and after dose-increasing of empagliflozin.

2: Comparing the change before and after dose-increasing of empagliflozin.
1.GA
2.FPG (mg/dL)
3.systolic blood pressure (mmHg)
4.diastolic blood pressure (mmHg)
5.lipid profile
6.renal function: eGFR (ml/min/1.73m2)
7.liver function: AST, ALT, GGT
8.FIB-4 index
9.body weight (kg), BMI (kg/mm2)
10.hematocrit

3: Association the change of HbA1c.
1.GA
2.FPG (mg/dL)
3.systolic blood pressure (mmHg)
4.diastolic blood pressure (mmHg)
5.lipid profile
6.renal function: eGFR (ml/min/1.73m2)
7.liver function: AST, ALT, GGT
8.FIB-4 index
9.body weight (kg), BMI (kg/mm2)
10.hematocrit
11.detail of medication and number of medication
12. nutrition counselling

4: Association the change of body weight.
1.GA
2.FPG (mg/dL)
3.systolic blood pressure (mmHg)
4.diastolic blood pressure (mmHg)
5.lipid profile
6.renal function: eGFR (ml/min/1.73m2)
7.liver function: AST, ALT, GGT
8.FIB-4 index
9.HbA1c (%)
10.hematocrit
11.detail of medication and number of medication
12. nutrition counselling

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

The selection criteria for the subjects is as follow.
1. Patients who have been diagnosed as type 2 diabetes.
2. Patients who were taking empagliflozin 10mg orally and then increased the dose to 25mg.
3. Patients who have not received new therapeutic intervention (new administration or dose increase) with other drugs during the period from 3 months before empagliflozin dose increase to 6 months after dose increase.
4. Patients who have not received inpatient treatment from 3 months before empagliflozin dose increase to 6 months after dose increase.

Key exclusion criteria

The exclusion criteria for the subjects are as follow.
1. Subjects with acute and/or chronic inflammation
2. Subjects with fresh cardiovascular and/or cerebrovascular diseases
3. Subjects with liver cirrhosis.
4. Subjects with severe respiratory disease or severe heart failure
5. Subjects with alcoholicsm or medicinal intoxication
6. Subjects with psychosis
7. Subjects who doctors judge as unfitness

Target sample size

100

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Matsumura

Organization

Nishinihon Hospital

Division name

Metabolic Medicine

Zip code

861-8034

Address

3-20-1 Hattanda, Higashi-ku, Kumamoto

TEL

096-380-1111

Email

takeshim@gpo.kumamoto-u.ac.jp

Name of contact person

1st name	Tanaka
Middle name	Matsumura
Last name	Tomoko

Organization

Nishinihon Hospital

Division name

Department of Pharmacy

Zip code

861-8034

Address

3-20-1 Hattanda, Higashi-ku, Kumamoto

TEL

096-380-1111

Homepage URL

Email

kusuri@nishinihon.or.jp

Institute

Department of Metabolic Medicine, Nishinihon Hospital

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Please Select

Co-sponsor

Name of secondary funder(s)

Organization

Nishinihon Hospital Ethics Review Committee

Address

3-20-1 Hattanda, Higashi-ku, Kumamoto

Tel

096-380-1111

Email

takeshim@gpo.kumamoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

西日本病院（熊本）

Date of disclosure of the study information

2020

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2020

Year

05

Month

07

Day

Date of IRB

Anticipated trial start date

2020

Year

09

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a retrospective observational study.

Registered date

2020

Year

08

Month

25

Day

Last modified on

2020

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047399