UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018806 |
|---|---|
| Receipt number | R000021757 |
| Scientific Title | Study on changes in urinary glucose concentrations in Type 2 diabetes patients treated with the selective SGLT2 inhibitor luseogliflozin |
| Date of disclosure of the study information | 2015/09/16 |
| Last modified on | 2019/01/08 09:04:08 |
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Basic information
Public title
Study on changes in urinary glucose concentrations in Type 2 diabetes patients treated with the selective SGLT2 inhibitor luseogliflozin
Acronym
Study on changes in urinary glucose concentrations in Type 2 diabetes patients treated with the selective SGLT2 inhibitor luseogliflozin
Scientific Title
Study on changes in urinary glucose concentrations in Type 2 diabetes patients treated with the selective SGLT2 inhibitor luseogliflozin
Scientific Title:Acronym
Study on changes in urinary glucose concentrations in Type 2 diabetes patients treated with the selective SGLT2 inhibitor luseogliflozin
Region
| Japan |
Condition
Condition
Patients with Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify factors affecting long-term changes in urinary glucose concentrations and body weight loss in patients with Type 2 diabetes treated with luseogliflozin by measuring changes in urinary glucose concentrations, using a urinary glucose measurement device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary glucose level, CGM, HbA1c, fasting blood glucose level and body weight from before the start of treatment until completion (Week 24) or discontinuation of treatment
Key secondary outcomes
Urine volume at measurement of urinary glucose, subcutaneous fat, visceral fat, insulin, EPA/AA ratio, FFA, ghrelin, blood ketone bodies, 1.5-anhydro-D-glucitol, and QOL from before the start of treatment until completion (Week 24) or discontinuation of treatment
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
Luseogliflozin (2.5 mg/dose) will be orally administered once a day before or after breakfast for 24 weeks
If responses are insufficient, the dose may be increased to 5 mg (once a day) after testing at 12 weeks after the start of treatment, provided that responses are observed carefully.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with HbA1c (NGSP level) between 7.0% and 10.5% at the time informed consent is obtained
(2) Patients previously treated with dietary therapy for more than 4 weeks prior to the start of treatment with luseogliflozin
(3) Patients who have not been previously treated with any antidiabetics within 4 weeks prior to the start of treatment with luseogliflozin
(4) Patient between 20 years and 65 years old, regardless of sex, at the time informed consent is obtained
(5) Outpatients
(6) Patients who understand the explanation provided regarding the clinical study and can provide written informed consent
Key exclusion criteria
(1) Patients diagnosed with diabetes other than Type 2 diabetes, including Type 1 diabetes, diabetes associated with diseases other than Type 2 diabetes and gestational diabetes
(2) Patients with severe renal function impairment, including nephrotic syndrome, renal failure and dialysis
(3) Patients with severe hepatic function impairment, including cirrhosis
(4) Patients with severe heart diseases, including heart failure, myocardial infarction and cerebral infarction, or patients with prior history of any of these diseases during the past 6 months
(5) Patients with severe diabetic microvascular diseases, including diabetic retinopathy and diabetic neuropathy that does not sufficiently respond to treatment
(6) Patients with concurrent or prior history of malignant tumors, excluding those not receiving treatment for their disease and who have not experienced recurrence and those who are not likely to experience recurrence during participation in the study
(7) Patients who have previously developed hypersensitivity to luseogliflozin
(8) Patients who are alcoholics
(9) Females who are pregnant or are likely to be pregnant, or those who want to become pregnant during participation in the study and nursing mothers
(10) Patients who the physician in charge determines as ineligible for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Jinnouchi |
Organization
Medical corporation Jinnouchi society Jinnouchi Hospital
Division name
The director
Zip code
Address
6-2-3, Kuhonji, Chuo-ku, Kumamoto-shi, Kumamoto,Japan
TEL
096-363-0011
hideaki@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | The study secretariat |
Organization
Satt Co.,Ltd
Division name
Clinical study promotion group
Zip code
Address
2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5312-5026
Homepage URL
azusa.kaneko@sa-tt.co.jp
Sponsor or person
Institute
Medical corporation Jinnouchi society Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama 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
Address
Tel
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
| 2015 | Year | 09 | Month | 16 | 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
The urine sugar discharge amount changed significantly before and luseogliflozin taking starting, but after it began there were slightly fluctuations. A weight change was a plateau after starting after 3 months, but I can think it doesn't depend on decline of the urine sugar discharge amount.
Improvement of the numerical value related to insulin resistance was seen more than the 3rd month.
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
| 2015 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021757
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