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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025334
Receipt No. R000029147
Scientific Title Effects of luseogliflozin on intravaginal bacteria and fungi in patients with type 2 diabetes
Date of disclosure of the study information 2016/12/20
Last modified on 2016/12/20

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Basic information
Public title Effects of luseogliflozin on intravaginal bacteria and fungi in patients with type 2 diabetes
Acronym Effects of luseogliflozin on intravaginal bacteria and fungi
Scientific Title Effects of luseogliflozin on intravaginal bacteria and fungi in patients with type 2 diabetes
Scientific Title:Acronym Effects of luseogliflozin on intravaginal bacteria and fungi
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 of effects of luseogliflozin on intravaginal bacteria and fungi
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intravaginal fungi and Gram-positive and -negative bacilli
Key secondary outcomes Body mass index, HbA1c, and serum triglyceride and total, HDL, and LDL cholesterol levels

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
25 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria Type 2 diabetes patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria Having severe nephropathy.
Target sample size 40

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

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

Sponsor
Institute Research Center of Health, Physical Fitness and Sports, Nagoya University
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 20 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
2014 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 10 Day
Last follow-up date
2015 Year 06 Month 10 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
2015 Year 07 Month 30 Day
Date analysis concluded
2016 Year 11 Month 20 Day

Other
Other related information Female patients with type 2 diabetes are divided into two group: premenopausal and postmenopausal groups. Each patient are administered SGLT2 inhibitor luseogliflozin once daily at a dose level 2.5 mg for 6 months. Immediately before and after 6 months of luseogliflozin treatment, vaginal secretions are collected, and the secretions collected are incubated in media for identification and quantification of the bacteria. Body weight is measured immediately before and at the end of 6 months of luseogliflozin treatment. Blood samples are obtained before and after the treatment to measure HbA1c and serum triglyceride and HDL and LDL cholesterol levels.

Management information
Registered date
2016 Year 12 Month 20 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029147

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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