UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036038 |
|---|---|
| Receipt number | R000040689 |
| Scientific Title | Efficacy of Ipragliflozin in type 1 diabetic patients |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2020/03/11 10:20:08 |
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Basic information
Public title
Efficacy of Ipragliflozin in type 1 diabetic patients
Acronym
Efficacy of Ipragliflozin in type 1 diabetic patients
Scientific Title
Efficacy of Ipragliflozin in type 1 diabetic patients
Scientific Title:Acronym
Efficacy of Ipragliflozin in type 1 diabetic patients
Region
| Japan |
Condition
Condition
type 1 diabetic patients
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of Ipragliflozin in type 1 diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glycemic variability and treatment satisfaction
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Out patients who receive therapy at our hospital
Type 1 diabetic patients
HbA1c: >= 7.0 and < 10%
Patients who give written informed consent to participate in the study
Key exclusion criteria
Patients who had ketoacidosis or coma
Malignancies or other diseases with poor prognosis
eGFR<60mL/min/1.73m2
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | kazuya |
| Middle name | |
| Last name | murata |
Organization
Ise Red Cross Hospital
Division name
Department of diabetes and metabolism
Zip code
516 8512
Address
1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL
0596-28-2171
healthcheck@ise.jrc.or.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | ida |
Organization
Ise Red Cross Hospital
Division name
Department of diabetes and metabolism
Zip code
516-8512
Address
1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL
0596-28-2171
Homepage URL
bboy98762006@yahoo.co.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Department of Metabolic Diseases
Institute
Department
Personal name
Funding Source
Organization
Ise Red Cross Hospital
Department of Metabolic Diseases
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
Ethics committee of Ise Red Cross Hospital
Address
1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
Tel
0596-28-2171
jimubu@ise.jrc.or.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
| 2019 | Year | 03 | 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
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040689
