UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010397
Receipt number R000012161
Scientific Title Effect of combination therapy with DPP-4 inhibitor and omega 3-fatty acid on glycemic control in type2 diabetes with dyslipidemia
Date of disclosure of the study information 2013/04/02
Last modified on 2015/10/08 12:01:22

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Basic information

Public title

Effect of combination therapy with DPP-4 inhibitor and omega 3-fatty acid on glycemic control in type2 diabetes with dyslipidemia

Acronym

Effect of combination therapy with DPP-4 inhibitor and omega 3-fatty acid on glycemic control

Scientific Title

Effect of combination therapy with DPP-4 inhibitor and omega 3-fatty acid on glycemic control in type2 diabetes with dyslipidemia

Scientific Title:Acronym

Effect of combination therapy with DPP-4 inhibitor and omega 3-fatty acid on glycemic control

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the effect of addition of omega 3 fatty acid on-going DPP-4 inhibiter on glycemic control in patients with type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Reduction rate of postprandial glucose and HbA1c after add-on therapy with omega 3-fatty acid

Key secondary outcomes

1)Lipid parameters(TC,LDL-C, HDL-C, TG,etc)
2)Renal function (ACR, Cr, eGFR)


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

Undergoing DPP-4 inhibiter, such as alogliptin 12.5mg , Vildagliptin 100mg, Sitagliptin 50mg etc for over 12 weeks, patients are treated with omega 3 fatty acid 1800mg for 16 weeks.

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes with dsylipidemia
2) Pts with written IC
3)Age more than 20, less than 85
4) HbA1c :more than 7.0%
5)before test registration &#8211;alogliptin 12.5mg, vildagliptin 100mg,sitagliptin 50mg, or linagliptin 5mg for at least 12 weeks and outpatient

Key exclusion criteria

1)severe ketosis, diabetic coma within 6 months
2)present or history of CHF
3)severe infection, before operation, severe trauma
4)severe hepatic dysfunction
5)or severe renal dysfunction (SCr:more than 2.0mg/dl or eGFR less than 30)
6)pregnacy
7)Allergy for DPP-4 inhibitores or omega 3 fatty acid
8)Patients judged by the investigator to be ineligible for some other reason
9)Changes of doses with oral hypoglycemic agents or antihyperelipidemic drugs during the study

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadashi Yamakawa

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

yamakawat@urahp.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Suzuki

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

jsuzuki@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立大学附属市民総合医療センター(神奈川県)
金沢内科クリニック(神奈川県)


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 02 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

2013 Year 03 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 02 Day

Last follow-up date

2016 Year 01 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

2013 Year 04 Month 02 Day

Last modified on

2015 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012161


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name