UMIN-CTR Clinical Trial

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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute	Cardioangiology, Kitasato University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005360

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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