UMIN-CTR Clinical Trial

Public title

Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin

Acronym

Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin

Scientific Title

Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin

Scientific Title:Acronym

Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the relationship between changes in body weight during the early phase of treatment with tofogliflozin and dehydration during the middle phase of the treatment, in patients with type 2 diabetes mellitus

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Relationship between changes in body weight at Week 2 of treatment and the frequency of deviations from upper limit reference values for hematocrit at Week 24

Key secondary outcomes

(1) Safety: frequency of adverse effects and adverse events (events, severity, incidence rates, etc.)
(2) Efficacy: changes over time in the parameters listed below.
HbA1c (NGSP value), blood sugar, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglycerides, BUN, serum creatinine, uric acid, body weight, blood pressure, hematocrit.
(3) Others
changes from baseline in HbA1c, body weight, hematocrit, lipid, uric acid, and frequency of adverse events, etc. in tofogliflozin-treated patients after stratification based on baseline values

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

From baseline to Week 24, patients will receive oral tofogliflozin at a dose of 20 mg per administration, once daily, either before or after breakfast.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients diagnosed with diabetes mellitus
(2) Patients aged 20 years of age or more
(3) Patients who have no prior history of using SGLT2 inhibitors
(4) Patients who provide written informed consent to participate in this clinical study

Key exclusion criteria

(1) Patients with a prior history of hypersensitivity to any of the ingredients of tofogliflozin
(2) Patients with severe ketosis, diabetic coma, or precoma
(3) Patients with severe infections or severe injuries or those who are scheduled to receive or have received surgical treatment
(4) Patients with severe hepatic function impairment
(5) Patients with end-term renal failure who are on hemodialysis or peritoneal dialysis
(6) Patients who are determined by principal investigators or sub-investigators to be ineligible for the clinical study

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Sugawara

Organization

General incorporated Tokyo Physicians Association

Division name

Chairman

Zip code

Address

Sumitomo Corporation Takebashi BLDG 13F,1-2-2 Hitotsubashi, Chiyoda-ku, Tokyo, Japan

TEL

03-6256-0414

Email

topa@proof.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Clinical Study Support Center

Organization

Satt Co., Ltd.

Division name

Promotion division of the clinical study

Zip code

Address

Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-5312-5026

Homepage URL

Email

sweat@sa-tt.co.jp

Institute

General incorporated Tokyo Physicians Association

Institute

Department

Personal name

Organization

Kowa Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

03

Month

24

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

13

Day

Last follow-up date

2017

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

04

Month

07

Day

Last modified on

2017

Year

06

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019787