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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017062
Receipt No. R000019787
Scientific Title Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin
Date of disclosure of the study information 2015/04/07
Last modified on 2017/06/16

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Basic information
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
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute General incorporated Tokyo Physicians Association
Institute
Department

Funding Source
Organization Kowa Company, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 04 Month 07 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
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
Other related information

Management information
Registered date
2015 Year 04 Month 07 Day
Last modified on
2017 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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