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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
