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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026042
Receipt No. R000029931
Scientific Title Long-term effects of dapagliflozin, a SGLT2 inhibitor, on glucose metabolism in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2017/02/08
Last modified on 2017/02/08

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Basic information
Public title Long-term effects of dapagliflozin, a SGLT2 inhibitor, on glucose metabolism in patients with type 2 diabetes mellitus
Acronym Long-term effects of dapagliflozinon glucose metabolism in patients with diabetes mellitus
Scientific Title Long-term effects of dapagliflozin, a SGLT2 inhibitor, on glucose metabolism in patients with type 2 diabetes mellitus
Scientific Title:Acronym Long-term effects of dapagliflozinon glucose metabolism in patients with diabetes mellitus
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To infestigate long-term effects of dapagliflozin, a SGLT2 inhibitor, on glucose metabolism in patients with type 2 diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fasting blood glucose, HbA1c, urinary sugar
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 HbA1c > 7.0%
Patients treated with dapagliflozin for more than 24 week
Key exclusion criteria Repeated urinary tract infection
HbA1c < 7.0%
BMI < 22
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takumi Kawaguchi
Organization Kurume University School of Medicine
Division name Division of Gastroenteorlogy, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan.
TEL 0942317561
Email takumi@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Kawaguchi
Organization Kurume University School of Medicine
Division name Division of Gastroenteorlogy, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan.
TEL 0942317561
Homepage URL
Email takumi@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
AstraZeneca CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kurume Internal Medicine Group
Name of secondary funder(s) Kurume Internal Medicine Group

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
2017 Year 02 Month 08 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 02 Month 08 Day
Last modified on
2017 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029931

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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