UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022804
Receipt number R000026282
Scientific Title The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients
Date of disclosure of the study information 2016/06/20
Last modified on 2018/11/28 17:51:26

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Basic information

Public title

The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients

Acronym

The efficacy of SGLT2 inhibitor switching from thiazolidine in type 2 diabetes patients

Scientific Title

The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients

Scientific Title:Acronym

The efficacy of SGLT2 inhibitor switching from thiazolidine in type 2 diabetes patients

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In type 2 diabetes patients during the treatment in the treatment of diabetes, including Pioglitazone, to assess the efficacy of SGLT2 inhibitor Dapagliflozin about body weight, changes in blood glucose control, lipid, blood pressure, and metabolic-related factors, such as liver function influence by switching Pioglitazone into Dapagliflozin.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Body weight and HbA1c at 24 weeks

Key secondary outcomes

Abdominal circumference
Blood pressure
Lipid metabolism
Liver function
Complete blood count, renal function, electrolyte
Urine test
Frequency of hypoglycemia
Dose of antidiabetic drugs before and during clinical trial


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Keeping Pioglitazone

Interventions/Control_2

Switching Pioglitazone to Dapagliflozin

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Age: 20 to 80 years old
2) HbA1c: 6.0-8.5%
3) BMI: 23 kg/m^2 and more
4) eGFR: 45ml/min/1.73m^2 and more
5) Taking Pioglitazone(15-30 mg per day) for more than 12 weeks
6) Written informed consent

Key exclusion criteria

1) Already taking SGLT2 inhibitor agents
2) With hypersensitivity to Dapagliflozin
3) With severe or unstable retinopathy
4) With severe liver or kidney disfunction
5) With severe diabetic ketosis, pre-coma, or coma
6) With severe infection or trauma, or in perioperation
7) With pregnancy
8) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido Unverstiy Hospital

Division name

Department of Internal Medicine II

Zip code


Address

n14w5, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

hmiyoshi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kyu Yong Cho

Organization

Hokkaido Unverstiy Hospital

Division name

Department of Internal Medicine II

Zip code


Address

n14w5, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL


Email

kyuyong-cho@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido Unverstiy Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Unverstiy Hospital

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

北海道大学病院(北海道)、栗原内科(北海道)、青木内科(北海道)、釧路赤十字病院(北海道)、苫小牧市立病院(北海道)、北海道中央労災病院せき損センター(北海道)、萬田記念病院(北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1111/dom.13557

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

Completed

Date of protocol fixation

2016 Year 06 Month 13 Day

Date of IRB


Anticipated trial start date

2016 Year 07 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

2016 Year 06 Month 20 Day

Last modified on

2018 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026282


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name