UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037158
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email y.kawaguchi@minamiosaka.com

Sponsor
Institute Minami Osaka hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.