UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021977 |
|---|---|
| Receipt number | 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 | 2022/10/24 11:31:46 |
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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
| 80 | 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
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
raizo@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University, School of Medicine
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ21-0696/_article/-char/en
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ21-0696/_article/-char/en
Number of participants that the trial has enrolled
19
Results
Primary endpoint
There was no significant change in glucagon fluctuation before and after Luseogliflozin administration.
Secondary endpoint
1. GLP-1 secretion during meal tolerance test increased after Luseogliflozin administration but GIP secretion did not change.
2. The secretion ratio of glucagon to insulin, GLP-1, and GIP during meal tolerance test were not changed.
3. HOMA-R and Matsuda index were both improved, as were HOMA-beta and Disposition index.
Results date posted
| 2022 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Total 20 participants (14 males and 6 females) were administrated Luseogliflozin, and one female participants dropped out during research because of her own will, not adverse event. Their age, duration of diabetes, body mass index (BMI) and HbA1c before administrated Luseogliflozin ware 53+-14 year-old (range 33-78), 5+-5 years (range 1-16), 28.6+-5.9 kg/m2 (range 17.5-43.6) and 8.2+-0.8% (range 7.1-9.9) respectively.
Participant flow
The first participant was enrolled on May 6, 2016.By June 2018, 12 participants were registered. In addition, 4 additional participants were registered by June 2019 and other 4 additional participants were registered by June 2020. The last participant data was collected on July 10, 2020.
Adverse events
No adverse events were observed during the course of this research.
Outcome measures
Primary endpoint
Comparison of changes in blood glucose levels and glucagon secretion level during meal tolerance test before and 12 weeks after Luseogliflozin administration
Secondary endpoint
1.Comparison of alteration in GLP-1 and GIP scretion during meal tolerance test before and after Luseogliflozin administration
2.Comparison of alteration in secretion ratio of glucagon to insulin, GLP-1 and GIP
3.Comparison of changes in insulin sensitivity index (HOMA-R, Matsuda index) and index of beta-cell function (HOMA-beta, Disposition index) before and 12 weeks after Luseogliflozin administration during meal tolerance test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2020 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 12 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025234
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/01/24 | 5_研究計画書最終版.docx |
| Research case data specifications | |
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