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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013539
Receipt No. 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

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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
Email 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
Email knemoto@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Department of Internal Medicine
Division of Diabetology, Nephrology, Neurology
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015819

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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