UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019476
Receipt number R000022524
Scientific Title Defining a novel law of glucose homeostasis under Dapagliflozin usage by mathematical model approach
Date of disclosure of the study information 2016/01/01
Last modified on 2016/02/22 11:51:52

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Basic information

Public title

Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach

Acronym

Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach

Scientific Title

Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach

Scientific Title:Acronym

Defining a novel law of glucose homeostasis
under Dapagliflozin usage
by mathematical model approach

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Finding a new blood glucose homeostasis law using 100 person's time series data ,which were obtained during OGTT or Hyperinsulinemic euglycemic clamp

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Finding a new blood glucose homeostasis law

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

One hundred person's time series boold glucose value or hormons concentration data, which were obtained immediately after taking SGLT2 inhibitor.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1)Volunteers or Type 2 diabetes mellitus who has not been administered SGLT2 inhibitors
2) 20-75 years old,
3) having a will to attend this study

Key exclusion criteria

1) pregnant or breast-feeding women
2) insulin antibody positive (>10 arbitrary unit)
3) having allergy or skin trouble for oral hypoglycemic agants or insulin
4) type 1 diabetes or other specific type of diabetes
5) severe liver dysfunction (transaminase twice over the normal limit)
6) severe renal dysfunction (eGFR < 50)
7) severe heart failure (NYHA>2)
8) long-acting insulin, long-acting GLP-1 RA, or long-acting DPP-4 inhibitor user
9) psychological disorder
10) recent severe hypoglycemia or hypoglycemia unawareness
11) contraindication of dapagliflozine
11) others inappropriate for this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology Department of Internal Medicine,

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

81-76-382-5861

Email

kzhkskgc@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology Department of Internal Medicine,

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

81-76-382-5861

Homepage URL


Email

kzhkskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

AstraDeneca, Ono pharmaceutical Co., LTD

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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

神戸大学医学部附属病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2016 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

Terminated

Date of protocol fixation

2015 Year 10 Month 23 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 23 Day

Last modified on

2016 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name