UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013539 |
|---|---|
| Receipt number | R000015819 |
| Scientific Title | Efficacy and Safety of SGLT-2 inhibitor to break loose from glucose toxicity and to withdraw insulin therapy in type 2 diabetic inpatients |
| Date of disclosure of the study information | 2014/03/31 |
| Last modified on | 2016/03/24 14:58:16 |
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Basic information
Public title
Efficacy and Safety of SGLT-2 inhibitor to break loose from glucose toxicity and to withdraw insulin therapy in type 2 diabetic inpatients
Acronym
Efficacy and Safety of SGLT-2 inhibitor to break loose from glucose toxicity and to withdraw insulin therapy in type 2 diabetic inpatients
Scientific Title
Efficacy and Safety of SGLT-2 inhibitor to break loose from glucose toxicity and to withdraw insulin therapy in type 2 diabetic inpatients
Scientific Title:Acronym
Efficacy and Safety of SGLT-2 inhibitor to break loose from glucose toxicity and to withdraw insulin therapy in type 2 diabetic inpatients
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Possibility to break loose from glucose toxicity and to withdraw insulin therapy in type 2 diabetic inpatients combined with metformin , GLP-1 receptor agonist, and SGLT-2 inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of insulin usage, Rate of insulin withdrawal, Change rate of body weight, Incidence rate of hypoglycemia
Key secondary outcomes
Diabetic duration, Body weight, HOMA-B,HOMA-R, delta C-peptide, Blood pressure, LDL-C, HDL-C, TG, UA, Ketone bodies in blood, FFA, Renin activity, Aldosterone, Glucose concentration in urine, Microalbumin in urine, Protein in urine, NAG in urine, Beta-2 microglobulin in urine, Ca excretion in urine, C-peptide in urine, Amino acids in urine
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT-2 inhibitor(-)
Interventions/Control_2
SGLT-2 inhibitor(+)
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
1.HbA1c >=8.0 inadequately controlled type 2 diabetic patients
2. age >=20, <75
3.BMI >=22 kg/m2, and eGFR >=45 ml/min/1.73m2
4. patients who can get written consent
Key exclusion criteria
1.age <20, >=75
2.BMI <22 kg/m2
3.eGFR <45 ml/min/1.73m2
4. anti-GAD antibody titer >=10 or insulin-dependent
5. patients who have anemia (Hb male <12 g/dl, female <11 g/dl)
6. patients who have cancer, or infection
7. patients judged to be disqualified to this research by physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Maegawa |
Organization
Shiga University of Medical Science, Department of Internal Medicine
Division name
Devision of Endocrinology and Metabolism
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
+81-77-548-2222
maegawa@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Nemoto |
Organization
Shiga University of Medical Science, Department of Internal Medicine
Division name
Devision of Endocrinology and Metabolism
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
+81-77-548-2223
Homepage URL
knemoto@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Department of Internal Medicine
Division of Diabetology, Nephrology, Neurology
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Department of Internal Medicine
Division of Diabetology, Nephrology, Neurology
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
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
滋賀医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2016 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015819
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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