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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name