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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013509
Receipt No. 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

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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
Institute Misaki naika clinic
Institute
Department

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
URL(English) https://upload.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


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