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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004480 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Patients withtype 2 diabetes and cardiovascular disease or atherosclerosis-prone. | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Organization | Kitasato University Hospital, Cardioangiology | ||||||
Division name | CRC center of Cardioangiology | ||||||
Zip code | |||||||
Address | |||||||
TEL | 042-778-8111 | ||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |