UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037158 |
|---|---|
| Receipt number | R000042340 |
| Scientific Title | Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2019/06/26 |
| Last modified on | 2020/04/14 15:43:32 |
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Basic information
Public title
Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Acronym
Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Scientific Title
Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Scientific Title:Acronym
Comparison of safety and efficacy of Tofogliflozin and Ipragliflozin in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tofogliflozin is a drug with high protein binding rate and short half-life in blood. On the other hand, Ipragliflozin is a drug having a low protein binding rate and a long half life in blood. These two agents contrast in-vivo pharmacokinetics, and compare the effects on blood glucose fluctuation to examine the usefulness of SGLT2 inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of time less than 70 mg/dl (low blood glucose area) of continuous glucose monitoring (CGM)
Key secondary outcomes
The percentage of time of the glucose level of hyperglycemic area (180 mg/dl or more), euglycemic area (70-179 mg/dl), hypoglycemic area (less than 70 mg/dl), severe hypoglycemic area (less than 54 mg/dl) and nighttime (0 : 00-5: 59) hypoglycemic area in CGM.
Nighttime average blood glucose (0:00-5:59), daytime average blood glucose (6:00-23:59), blood glucose level 2 hours after every meal, 24-hour average blood glucose level, SD value, CV value, daily variation , M value, MAGE, urine glucose (0:00-7:30, 7:30-23:59), urine volume (0:00-7:30, 7:30-23:59).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tofogliflozin-Ipragliflozin group
Interventions/Control_2
Ipragliflozin-Tofogliflozin group
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.target age 20 years old or older under 75 years old.
2.Patients who have been diagnosed with type 2 diabetes for more than 1 year before starting the trial.
3.Basal supported oral therapy with insulin glargine U-300 from over 3 months ago.
4.Patients who are treating glycated hemoglobin (HbA1c) levels 7.0% or more and less than 10.5%.
5.Patients with body mass index (BMI) 20.0kg/m2 or more 45.0kg / m2 or less.
6.Patient with estimated glomerular filtration rate (eGFR) 45 mL/min/1.73 m2 or more.
Key exclusion criteria
1.Patients who have a history of severe ketosis, diabetic coma or pre-coma within 6 weeks of study start.
2.Patients who developed severe hypoglycemia (diabetic coma or pre-coma, convulsions, etc. require assistance by a third party) within 6 weeks of study start.
3.Patients who have a history of medically important renal diseases such as renal vascular occlusive disease, nephrectomy and renal transplantation.
4.Patients who show symptoms of dysuria, anuria, oliguria or urinary retention
5.Patients who developed urinary tract infections and genital infections with subjective symptoms within 6 weeks of the study start.
6. Patients with proliferative retinopathy (however, patients with photocoagulation etc. who have stable symptoms can be included).
7. Patients with severe gastrointestinal disorders within 2 weeks of the study, or patients with a history of severe gastrointestinal disorders.
8.Patients with acute coronary syndrome, cerebrovascular disorder within 3 months.
9. Women and lactating patients who may or may be pregnant.
10. Patients with severe infections, before and after surgery, with serious trauma.
11. Patients receiving systemic administration of corticosteroids.
12.Patients who have severe liver dysfunction (a high level of AST or ALT of at least 100 U / L).
13.Patients who have a history of allergies to the drugs intended for the study.
14. Patients with a malignant tumor or a history of malignant tumor.
15.Patients judged by the investigator as inappropriate as subjects.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Minami Osaka hospital
Division name
Internal Medicine
Zip code
559-0012
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 | Yuji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Minami Osaka hospital
Division name
Internal Medicine
Zip code
559-0012
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
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
Minami Osaka hospital
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka 559-0012, Japan
Tel
0666850221
y.kawaguchi@minamiosaka.com
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 | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042340
