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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020263
Receipt No. 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

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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
Email 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
Email research@ibec-jp.com

Sponsor
Institute Graduate School of Medical Sciences, Kyushu University,
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022897

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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