UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013509
Receipt number R000015779
Scientific Title Effects of combination therapy with sitagliptin and metformin on glycemic control-related factor, beta-cell function, lipid profile, and kidney function in patients with type 2 diabetes.
Date of disclosure of the study information 2014/03/26
Last modified on 2014/11/07 13:07:09

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Basic information

Public title

Effects of combination therapy with sitagliptin and metformin on glycemic control-related factor, beta-cell function, lipid profile, and kidney function in patients with type 2 diabetes.

Acronym

COAST study

Scientific Title

Effects of combination therapy with sitagliptin and metformin on glycemic control-related factor, beta-cell function, lipid profile, and kidney function in patients with type 2 diabetes.

Scientific Title:Acronym

COAST study

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Significance of combination therapy with sitagliptin and small amount of metformin for type 2 diabetes patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change rate of HbA1c

Key secondary outcomes

Chage rate of fasting blood glucose, active GLP-1, proinsulin / insulin ratio (P / I), HOMA-beta, HOMA-R, general lipid, RLP-C, LPL, HPLC lipoprotein quantitative analysis (H) , urinary albumin (ACR), cystatin C, L-type fatty acid binding protein (L-FABP), liver function.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1)HbA1c(JDS)6.1% was not achieved
after treatment by life style intervention
2)over 20 years old patient
3)Given informed consent

Key exclusion criteria

1) type 1 diabetes
2) had ketosis or coma within 6 month
3) after severe infection, operation or injure
4) impaired renal function (Serum Cr>1.5mg/dL for male,>1.3mg/dL for female)
5) is pregnancy or chance of pregnant
6) Under treatment by other anti-diabetic drugs
7) Has allergy to DPP-4 inhibitor
8) Patient who was considered to be appropriate to this study by attending physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuichi kuribayashi

Organization

Misaki naika clinic

Division name

Misaki naika clinic

Zip code


Address

6-44-9 Futawahigashi, Funabashi, Chiba, Japan

TEL

047-440-2222

Email

misakin@bh.wakwak.com


Public contact

Name of contact person

1st name
Middle name
Last name Nobuichi Kuribayashi

Organization

Misaki naika clinic

Division name

Misaki naika clinic

Zip code


Address

6-44-9 Futawahigashi, Funabashi, Chiba, Japan

TEL

047-440-2222

Homepage URL


Email

misakin@bh.wakwak.com


Sponsor or person

Institute

Misaki naika clinic

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation of Japan

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Jikei University,Hotaruno central naika

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

2014 Year 03 Month 26 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

2012 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2014 Year 05 Month 10 Day

Date trial data considered complete

2014 Year 05 Month 15 Day

Date analysis concluded

2014 Year 06 Month 30 Day


Other

Other related information

Chage rate of HbA1c , fasting blood glucose, active GLP-1, proinsulin / insulin ratio (P / I), HOMA-bata, HOMA-R, general lipid, RLP-C, LPL, HPLC lipoprotein quantitative analysis (H) , urinary albumin (ACR), cystatin C, L-type fatty acid binding protein (L-FABP), liver function.


Management information

Registered date

2014 Year 03 Month 25 Day

Last modified on

2014 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name