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

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 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

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

Value
https://center6.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