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 –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
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
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
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
