UMIN-CTR Clinical Trial

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

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Department of Metabolic Medicine, Nishinihon Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Please Select

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	西日本病院（熊本）

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 01 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	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
Other related information	This study is a retrospective observational study.

Management information
Registered date	2020 Year 08 Month 25 Day
Last modified on	2020 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047399