UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035555 |
|---|---|
| Receipt number | R000040503 |
| Scientific Title | Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/02/10 20:48:20 |
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Basic information
Public title
Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM
Acronym
Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM
Scientific Title
Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM
Scientific Title:Acronym
Efficacy and Safety of SGLT2 Inhibitor Ipragliflozin in with Type 1 Diabetes patients using FGM
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of SGLT2 inhibitor Ipragliflozin for patients with type 1 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c levels
Key secondary outcomes
For 3 days of FGM, percentage of time of blood glucose level of less than 70mg/dl (hypoglycemia range) , percentage of time of blood glucose level of 180mg/dl or more (hyperglycemia range), percentage of time of blood glucose level 70-179mg/dl (normoglycemia range), percentage of time of blood glucose level less than 54mg/dl (severely hypoglycemic range), percentage of time of nocturnal hypoglycemia (0:00-5:59, less than 70 mg/dl), frequency of severe hypoglycemia (the extent of occurrence of coma, premature coma, convulsions need of third-person assistance, SD value, CV value, day difference variation, M value, MAGE, change in BMI, the change of insulin dose.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administered once a day Ipragliflozin 50mg after breakfast for three months or more
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
1.Applicable age 20 years old and under 75 years old
2.Patients diagnosed with type 1 diabetes for more than 1 year from the start of the study
3.Patients who underwent multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) 12 weeks before the start of the study
4.Patients with glycated hemoglobin (HbA1c) levels 7.0% or more and less than 10.5%
5.patient with body mass index (BMI) 20kg/m2 or more and 45.0kg/m2 or less
Key exclusion criteria
1.The patient with severe ketosis, diabetic comA or previous coma within six weeks before examination start
2.The patient who developed severe hypoglycemia (a diabetic coma or a previous coma and convulsionsneed the assistance of the third person) within six weeks before examination start
3.The patient with medically important renal disease
such as a history of renal vascular occlusive disease, nephrectomy, kidney transplantations, etc
4.The patient with dysuria, anuria, oliguria or the symptom of the anuria
5.The patient whom urinary tract infection having subjective symptoms, a sexual organs infectious disease developed in within six weeks before examination start
6.The patient with a severe renal function disorder (eGFR <30mL/min/1.73m2 or serum creatinine level >= 2.0mg/dL) or the end-stage renal disease on dialysis
7.The patient with a proliferative retinopathy (however, patients symptoms are stable by implementing the photocoagulation, etc., can incorporate)
8.The patient complicated with serious digestive tract
disturbance within two weeks before examination start or the patient who has an operation career of serious digestive tract disturbance
9.The patient with pregnancy or may be pregnant and the patient in nursing
10.The patient with severe infectious disease, serious injury and before and after operation
11.The patient who receives systemic administration of corticosteroids drugs
12.The patient with a serious liver function disorder more than 100 U/l of AST or ALT
13.The patient with a history of allergy to Ipragliflozin
14.The patient with the past of a malignant tumor or the malignant tumor at the moment
15.In addition, patients who test the attending physician has determined to be inappropriate as a subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kawaguchi |
Organization
Minami Osaka Hospital
Division name
Internal Medicine
Zip code
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL
0666850221
y.kawaguchi@minamiosaka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Kawaguchi |
Organization
Minami Osaka Hospital
Division name
Internal Medicine
Zip code
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL
0666850221
Homepage URL
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka Hospital
Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
社会医療法人 景岳会 南大阪病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040503
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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