UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020263 |
|---|---|
| Receipt number | R000022897 |
| Scientific Title | Combination Therapy of SGLT2 Inhibitor and intensive Physical Exercises, focusing on the Prevention of Muscle Mass Reduction in Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2015/12/18 |
| Last modified on | 2019/04/08 14:48:41 |
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Basic information
Public title
Combination Therapy of SGLT2 Inhibitor and intensive Physical Exercises, focusing on the Prevention of Muscle Mass Reduction in Patients with Type 2 Diabetes
Acronym
Combination of SGLT2 inhibitor and Intensive Exercise in Diabetes.
Scientific Title
Combination Therapy of SGLT2 Inhibitor and intensive Physical Exercises, focusing on the Prevention of Muscle Mass Reduction in Patients with Type 2 Diabetes
Scientific Title:Acronym
Combination of SGLT2 inhibitor and Intensive Exercise in Diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes patients
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether administration of intensive exercise could prevent the reduction of muscle mass in patients with type 2 diabetes receiving an SGLT2 inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in fat free mass at 24 weeks from the base line after the administration of dapagliflozin administration with intensive exercise therapy.
Key secondary outcomes
Change in the following markers at 24 weeks from the base line after the administration of dapagliflozin administration with intensive exercise therapy.
1) HbA1c
2) Serum adiponectin
3) Leptin
4) IL-6
5) high-sensitive TNF-alpha
6) High sensitivity CRP
7) Body weight
8) Blood pressure
9) The urinary albumin-to-creatinine ratio
10) An implementation rate and degree of an exercize therapy 1,The number of steps 2,Activity time of 3.0 Mets or more 3,The number of implementation times of the resistance exercize and the number of sets.Only the groupe concomitantly performing the intensive exercize.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Five mg of dapagliflozin is to be administered orally once a day for 24 weeks, and walking of 6000 steps or more per day is practiced.
Interventions/Control_2
Five mg of dapagliflozin is to be administered orally once a day for 24 weeks, and walking of 8000 steps or more per day is practiced. Physical exercise of a medium strength (3.0 Mets) is carried out for 30 min or longer per day. In addition, as a resistance physical exercise, physical exercises of 6 items with 10 times x 3 sets are practiced per day as a target,
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetic patients with age of 20 years old or older but below 75 years old
2)Patients whose BMI is 18.5 kg/m2 or higher but below 35.0 kg/m2
3)Patients whose HbA1c is 6.5% or higher but below10.0% (examination values of week 0 are to be applicable)
4)Patients whose eGFR is 45 mL/min/1.73 m2 or higher
5)Patients who have been receiving medications without any change in the administration and dosage for more than 8 weeks prior to the registration
6)Patients who can abide by the designated dietary treatment and exercise therapy
7)Patients from whom a consent in writing for the participation in this study has been obtained in person
Key exclusion criteria
1) Type 1 diabetic patients
2) Patients with a medical history of hypersensitivity to some ingredient(s) of the SGTL2 Inhibitor
3) Patients suffering from severe ketosis, diabetic coma, or precoma
4) Patients with severe infections, patients before or after operations or having severe external injuries
5) Patients with severe renal dysfunction, or patients with end-stage renal disease or those undergoing dialysis
6) Patients with severe liver dysfunction
7) Patients who are highly likely to suffer from dehydration
8) Patients with pituitary gland dysfunction or adrenal gland dysfunction
9)Patients in dystrophia conditions, starvation status, irregular meal intake, insufficient dietary intake, or extremely weakened state
10) Patients with an excessive alcohol consumption
11) Pregnant women, patients who might be pregnant, and lactating women
12) Patients with active infectious diseases
13) Patients with malignancies
14)Patients with active diabetic proliferative retinopathy
15) Patients with glucocorticoid
16) Patients with insulin
17)Patients who have experienced hypoglycemia 3 times or more, which requires a drug treatment such as instillation with glucose before recovery
18) Patients who are judged to be inadequate to participate in this study by a doctor in charge
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Sonoda |
Organization
Graduate School of Medical Sciences, Kyushu University,
Division name
Department of Medicine and Bioregulatory Science,
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, 812-8582 Japan
TEL
092-642-5284
noriyuki@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohide Noumi |
Organization
IBEC Co.,Ltd.
Division name
CEO office
Zip code
Address
Tanaka Jun Build 3F,2-5-14 Terada-cho, Tennouji-ku,Osaka-shi 5430045,Japan
TEL
06-7172-1751
Homepage URL
research@ibec-jp.com
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University,
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
九州大学病院（福岡県）
東京医科歯科大学医学部附属病院（東京都）
福岡県済生会 飯塚嘉穂病院（福岡県）
国家公務員共済組合連合会 浜の町病院（福岡県）
飯塚病院（福岡県）
医療法人社団 高邦会 高木病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 18 | 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
146
Results
The study is not registered to UMIN because the specific clinical research studies are registered and released to jRCT due to the Clinical Research Law enforcement.
Results date posted
| 2019 | Year | 04 | Month | 08 | Day |
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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 23 | 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 | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022897
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