UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021977
Receipt No. R000025234
Scientific Title Alternation in glucagon secretion by dietary intake after administration of sodium glucose transporter-2 inhibitor.
Date of disclosure of the study information 2016/05/01
Last modified on 2019/04/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Alternation in glucagon secretion by dietary intake after administration of sodium glucose transporter-2 inhibitor.
Acronym Alternation in glucagon secretion by Sodium glucose transporter-2 inhibitor
Scientific Title Alternation in glucagon secretion by dietary intake after administration of sodium glucose transporter-2 inhibitor.
Scientific Title:Acronym Alternation in glucagon secretion by Sodium glucose transporter-2 inhibitor
Region
Japan

Condition
Condition Type 2(non-insulin dependent) diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the alternation in glucagon secretion pattern by dietary intake before and after 12 weeks administration of sodium glucose transporter-2(SGLT-2) inhibitor.
Basic objectives2 Others
Basic objectives -Others We design meal tolerance test to compare the alternation in glucagon secretion before and after administration of sodium glucose transporter-2(SGLT-2) inhibitor.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The alternation in glucagon secretion pattern by dietary intake before and after 12 weeks administration of sodium glucose transporter-2(SGLT-2) inhibitor.
Key secondary outcomes

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 Administration of sodium glucose transporter-2(SGLT-2) inhibitor, Luseogliflozin, and dose of Luseogliflozin is 25mg once a daily before breakfast, administration period of Luseogliflozin is 12wweks.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 (non-insulin dependent) diabetes patients who are controlled in diet and exercise,
and glycated Hb(HbA1c) is 7.0% or above and 10.0% or below.

Key exclusion criteria 1. A patient suffering from acute disease
2. In case of malignacy
3. Renal dysfunction (estimeted GFR <60ml/min)
4. Liver dysfunction (AST >100U/l, ALT >100U/l)
5. Pregnant or possibility of pregnant
6. Lactating mothers
7. A patient suffering from endocrine disorders
8. A patient administrated any drugs affect glucose metabolism
9. Diabetic patients who have taken any hypoglycemic agents include SGLT-2 inhibitor in proximate 6 months
10.A patient undergoing or having history of treatment for ischemic heart disease
11.Chronic heart failure (NYHA class 2 or worse)
12.A patient undergoing or having history of treatment for cerebro-vascular disease
13.A patient undergoing or multiple (3 times or more) history of urinary or genital tract infection
14.A patient accompanied with severe diabetic retinopathy, nephropathy, neuropathy
15.A patient in hyperglycemic crisis or accompanied with marked symptom of hyperglycemia
16.Taking diuretics
17.Correspond to contraindication of Luseogliflozin
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Raishi
Middle name
Last name Ichikawa
Organization Kitasato University, School of Medicine
Division name Department of diabetes, endocrinology and metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa-Pref, Japan
TEL 042-778-8111
Email raizo@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Raishi
Middle name
Last name Ichikawa
Organization Kitasato University, School of Medicine
Division name Department of diabetes , endocrinology and metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa-Pref, japan
TEL 042-778-8111
Homepage URL
Email raizo@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University, School of Medicine
Institute
Department

Funding Source
Organization This research is carried out with funding from Taisho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Kitasato Institute, Clinical Research Revies Board
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa-Pref, Japan
Tel 042-778-8273
Email rinri-n@kitasato-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

Other administrative information
Date of disclosure of the study information
2016 Year 05 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 11 Day
Date of IRB
2016 Year 04 Month 11 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 19 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.