UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026042 |
|---|---|
| Receipt number | 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 | 2025/08/17 17:36:40 |
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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 | Takumi |
| Middle name | |
| Last name | Kawaguchi |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenteorlogy, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942317561
takumi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Kawaguchi |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenteorlogy, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942317561
Homepage URL
takumi@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
Kurume University Clinical Research Center
Address
67, Asahi-machi, Kurume 830-0011, Japan
Tel
0942-35-3311
takumi@med.kurume-u.ac.jp
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
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
| 2025 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029931
