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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021584
Receipt No. R000024892
Scientific Title Effects of sodium-glucose co-transporter 2 inhibitor on metabolic parameters in patients with diabetes mellitus
Date of disclosure of the study information 2016/03/23
Last modified on 2019/03/25

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Basic information
Public title Effects of sodium-glucose co-transporter 2 inhibitor on metabolic parameters in patients with diabetes mellitus
Acronym Effects of SGLT2 inhibitor on metabolic parameters in patients with diabetes mellitus
Scientific Title Effects of sodium-glucose co-transporter 2 inhibitor on metabolic parameters in patients with diabetes mellitus
Scientific Title:Acronym Effects of SGLT2 inhibitor on metabolic parameters in patients with diabetes mellitus
Region
Japan

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

Objectives
Narrative objectives1 To investigate effects of SGLT2 inhibitor on glycemic control, serum lipids, hepatic function, and genital infection in patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lipid-metabolic parameters: serum total cholesterol, HDL and LDL cholesterol, and triglyceride levels
Hepatic function parameters: serum AST, ALT, and gamma-GTP levels
Genital infection (female): intravaginal bacteria and fungi
These parameters are compared before and 6 mo after the administration of SGLT2 inhibitor.
Key secondary outcomes Visceral fat area, basal metabolic rate, and serum insulin and adiponectin levels

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Any one of SGLT2 inhibitors (luseogliflozin (2.5 mg q.d.) , dapagliflozin (5 mg q.d.), tofogliflozin (20 mg q.d.), empagliflozin (10 mg q.d.), or canagliflozin (100 mg q.d.)) is administered for 6 mo
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
25 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria None.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masataka
Middle name
Last name Kusunoki
Organization Nagoya University
Division name Research Center of Health, Physical Fitness and Sports
Zip code 464-8601
Address Furo-cho, Chikusa-ku, Nagoya
TEL 052-789-3946
Email info@tonyo.jp

Public contact
Name of contact person
1st name Masataka
Middle name
Last name Kusunoki
Organization Nagoya University
Division name Research Center of Health, Physical Fitness and Sports
Zip code 464-8601
Address Furo-cho, Chikusa-ku, Nagoya
TEL 052-789-3946
Homepage URL
Email info@tonyo.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Self funding
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 Akishima Clinic
Address 4-2-29 Sakae, Naka-ku, Nagoya
Tel 052-243-1024
Email kusu0910noki@yahoo.co.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 医療法人社団織田会あきしまクリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 23 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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
2014 Year 07 Month 07 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2017 Year 10 Month 30 Day
Date of closure to data entry
2017 Year 11 Month 30 Day
Date trial data considered complete
2017 Year 12 Month 15 Day
Date analysis concluded
2017 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 23 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024892

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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