UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030446 |
|---|---|
| Receipt number | R000034219 |
| Scientific Title | Effect of SGLT2 inhibitor, Dapagliflozin combined with or without metformin on body composition in patients with type 2 diabetes |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/06/21 04:06:45 |
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Basic information
Public title
Effect of SGLT2 inhibitor, Dapagliflozin combined with or without metformin on body composition in patients with type 2 diabetes
Acronym
Effect of SGLT2 inhibitor combined with metformin on body composition
Scientific Title
Effect of SGLT2 inhibitor, Dapagliflozin combined with or without metformin on body composition in patients with type 2 diabetes
Scientific Title:Acronym
Effect of SGLT2 inhibitor combined with metformin on body composition
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 examine the changes of body composition and muscle strength between Dapagliflozin combined with or without metformin in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the changes in total body muscle mass evaluated by dual-energy x-ray absorptiometry (DXA) before and after 24 weeks between the two groups
Key secondary outcomes
Comparison of the changes in quadriceps muscle strength measured by a hand-held dynamometer before and after 24 weeks between the two groups
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Orally take a dose of 5mg of dapagliflozin once a day before or after breakfast in addition to the medicines taken at time of consenting.
If the blood glucose levels are high in patients after a month, it can be raised the dose of dapagliflozin to 10 mg once a day.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetic patients with insufficient glycemic control (HbA1c 7.0 to 10.0%) and BMI 22 kg/m2 and over
2)Patients who are administrating more than or equal to 750mg of metformin, or who aren't receiving metformin thrapy
3)over 20 and under 65 years old
4)outpatient
5)male and female
Key exclusion criteria
1)patients who administrating less than 750mg of metformin
2)patients who receive insulin injection therapy
3)hypersensitivity to study drugs on this study,
4)severe ketosis and diabetic coma or pre-coma
5)serious infective diseases, serious injury, pre- and per-operation
6)pregnancy, nursing woman or possibly pregnant woman
7)moderate or severe renal dysfunction (eGFR: less than 30 mL/min/1.73m2)
8)patients who receive steroids, growth hormone secretagogue, sex hormone agents
9)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
y2tanaka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Fukuda |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
h2fukuda@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
1)AstraZeneca K.K.
2)ONO PHARMACEUTICAL CO., 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
Bioethics Committee of St. Marianna University
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
soumu@marianna-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
| 2019 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034219
