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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000017619 |
Receipt No. | R000020419 |
Scientific Title | Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison. |
Date of disclosure of the study information | 2015/05/19 |
Last modified on | 2015/05/19 |
Basic information | ||
Public title | Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison. | |
Acronym | Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison. | |
Scientific Title | Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison. | |
Scientific Title:Acronym | Effects of Vildagliptin addition versus standard therapy on glycemic excursion in type2 diabetic patients after coronary intervention therapy: a 8-months, randomized, open-label, parallel-group comparison. | |
Region |
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Condition | |||
Condition | Type 2 diabetes mellitus | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To look at the effect of Vildagliptin on the change of blood sugar level |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Time spent in range 70-140 mg/dl |
Key secondary outcomes |
Base | |
Study type |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Vildagliptin | |
Interventions/Control_2 | Gliclazide | |
Interventions/Control_3 | control (diabetic patients without coronary artery diseases) | |
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 | ・Type II diabetes mellitus
・Coronary intervention case ・Age 20-75 y. o. ・Diabetic patients treated with stable low dose of SU (Gliclazide 0~40mg) and/or Metformin (0~750mg) for at least four weeks. |
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Key exclusion criteria | 1) Exclusion criteria will comply with local label
2) Coronary bypass graft operation 3) Severe valvular heart disease 4) Severe arrhythmia (Extrasystole > 10% of total beats, atrial fibrillation, atrial flutter, pacemaker implantation, high grade heart block) 5) Congestive heart failure (NYHA III, IV) 6) Malignant neoplasms 7) Use of gluco-corticosteroids, immuno-suppressant 8) Serum Cr > 2.5 mg/dl 9) Cerebrovascular infarction or hemorrhage 10) Aneurysms in great artery 11) Liver cirrhosis 12) Recent (within 4 weeks) usage of incretin related drugs 13) Blood glucose > 400mg/dl or insulin usage 14) Recent change in diabetic treatment in one month 15) Use of Insulin, GLP-1 analogue, and OHAs excluding SU and metformin |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Teikyo university school of medicine | ||||||
Division name | Department of Clinical Laboratory Medicine | ||||||
Zip code | |||||||
Address | 2-11-1 Kaga, Itabashi-ku, Tokyo | ||||||
TEL | 03-3964-1211 | ||||||
tfrkw@med.teikyo-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Teikyo university | ||||||
Division name | EBM Center | ||||||
Zip code | |||||||
Address | 2-11-1 Kaga, Itabashi-ku, Tokyo | ||||||
TEL | 03-3964-1211 | ||||||
Homepage URL | |||||||
mazda@med.teikyo-u.ac.jp |
Sponsor | |
Institute | Teikyo University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Novartis Pharma K.K. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | 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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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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=R000020419 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |