UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002261
Receipt number R000002759
Scientific Title Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.
Date of disclosure of the study information 2009/07/28
Last modified on 2016/01/28 10:20:47

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Basic information

Public title

Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.

Acronym

Evaluation of combination therapy with Statin and Ezetimible

Scientific Title

Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.

Scientific Title:Acronym

Evaluation of combination therapy with Statin and Ezetimible

Region

Japan


Condition

Condition

Pateients with type II diabetes combined with dyslipidemia

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of effect of combination therapy with Statin and Ezetimible for patients with type II diabetes and dyslipidemia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Examination of the rate change of glucouse metabolism and inflammatory marker
Examination of ameliorating effect in kidney function

Key secondary outcomes

Examination of the rate change of TC, HDL cholesterol, and TG
Decreasing rate of LDL cholesterol


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ezetimibe and Statin

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


Not applicable

Gender

Male and Female

Key inclusion criteria

For entry into the study, participants must meet all of the following criteria.
1) Type II diabetes
2) Dyslipidemia given statin drug over 3 months.
3) At the time of entry, ezetimibe is not taken.
4) Age: 20years or older
5) Gender: regardless
6) Outpatient/hospitalized: regardless
7) Agreements: capable of giving consent and written agreement.

Key exclusion criteria

1) Pregnant and/or breathfeeding, child-bearing potential women during this study.
2) Past history of severe allergic reactions to ezetimibe
3) Renal dysfunctioned. (ALT>2 x Normal range of each institute)
4) Uncontrolled diabetes mellitus (HbA1c>=9%)
5) Renal insufficiency (serum creatinine>2.0mg/dL)
6) Heart failure, cardiac infarct, unstable angina, or stroke whithin 3 months.
7) Recieving insulin therapy
8) Secondary hyperlipidemia and/or drug-induced hyperlipidemia
9) Familial hyperlipidemia
10) otherwise, treating physician judged not to be appropriate for inclusion in this study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Node, MD, PhD

Organization

Saga University

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-1-1, Nabeshima, Saga city, Saga

TEL

0952-34-2364

Email

node@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Node, MD, PhD

Organization

Saga University

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-1-1 Nabeshima, Saga

TEL

0952-34-2364

Homepage URL


Email

node@cc.saga-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Saga University

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Saga University

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2009 Year 07 Month 28 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

Completed

Date of protocol fixation

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 06 Month 01 Day

Last follow-up date

2015 Year 12 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

2009 Year 07 Month 28 Day

Last modified on

2016 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002759


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name