UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004480 |
|---|---|
| Receipt number | R000005360 |
| Scientific Title | Clinical study to investigate the effects of mitiglinide add-on therapy with pioglitazone in patients with type 2 diabetes and cardiovascular disease. |
| Date of disclosure of the study information | 2010/10/30 |
| Last modified on | 2012/11/02 15:15:18 |
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Basic information
Public title
Clinical study to investigate the effects of mitiglinide add-on therapy with pioglitazone in patients with type 2 diabetes and cardiovascular disease.
Acronym
Vascular endothelial function by mitiglinide add-on therapy
Scientific Title
Clinical study to investigate the effects of mitiglinide add-on therapy with pioglitazone in patients with type 2 diabetes and cardiovascular disease.
Scientific Title:Acronym
Vascular endothelial function by mitiglinide add-on therapy
Region
| Japan |
Condition
Condition
Patients withtype 2 diabetes and cardiovascular disease or atherosclerosis-prone.
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-atherosclerotic effects of mitiglinide add-on therapy in patients with atherosclerosis-prone and type 2 diabetes, compared with pioglitazone alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy: Changes from baseline in vascular endothelial function
Safety: adverse event and laboratory tests
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dual treatment with mitiglinide (30 mg/day) and pioglitazone (15-30 mg/day) for 12 weeks
Interventions/Control_2
monotherapy with pioglitazone (15-30 mg/day) alone for 12 weeks
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
high-risk patients with cardiovascular disease with type 2 diabetes
1. pioglitazone usage (> 3 months)
2. HbA1c 6.5-8.0% (variance <0.5% in recent 2 months)
3. patients who agree the study dezine and protocol
Key exclusion criteria
1. acute coronary syndrome (< 3 weeks)
2. moderate to severe heart failure (BNP > 200 pg/mL)
3. SU usage in recent 3 months
4. insulin usage
5. severe diabetic retinopathy
6. mitiglinide usage
7. impossible to use mitiglinide or pioglitazone
8. impossible to evaluate precise effects of mitiglinide or pioglitazone
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minako Yamaoka-Tojo |
Organization
Kitasato University School of Allied Health Sciences
Division name
PT
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University Hospital, Cardioangiology
Division name
CRC center of Cardioangiology
Zip code
Address
TEL
042-778-8111
Homepage URL
Sponsor or person
Institute
Cardioangiology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Cardioangiology, Kitasato University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 30 | Day |
Last modified on
| 2012 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005360
