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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017113 |
Receipt No. | R000019543 |
Scientific Title | Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus |
Date of disclosure of the study information | 2015/05/26 |
Last modified on | 2018/10/15 |
Basic information | ||
Public title | Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus | |
Acronym | Comparative study of ipragliflozin versus metformin on adipocytokine levels | |
Scientific Title | Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus | |
Scientific Title:Acronym | Comparative study of ipragliflozin versus metformin on adipocytokine levels | |
Region |
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Condition | ||||
Condition | type 2 diabetic patients with coronary artery disease | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We investigate the effect of ipragliflozin or metformin in combination with DPP4-inhibitors on adipocytokine levels in type 2 diabetic patients with coronary artery disease. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Changes in adipocytokine |
Key secondary outcomes | Changes in glucose metabolism
Changes in body weight and abdominal circumference Changes in laboratory parameters Assessment of vascular event |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is 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 | group A: additive therapy of ipragliflozin 50-100mg once daily to DPP4 inhibitor for 6 months
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Interventions/Control_2 | Group B: additive therapy of metformin 250-750mg twice daily to DPP4 inhibitor for 6 months
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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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 | 1) Patients who have a history of following coronary heart diseasese
CABG or PCI was performed more than 6 months before >= 50% coronary artery stenosis according to the ACC/AHA classification was found by CAG 2) Diabetic patients under treatment of DPP-4 inhibitor more than 3 months 3) Patients who are judged to require the more glucose-lowering therapy |
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Key exclusion criteria | 1) Patients with malignancy
2) Patients with history of hypersensitivity against DPP4 inhibitor, SGLT2 inhibitor, and biguanide drugs 3) patients whose glycemic control is extremely poor (HbA1c >=10%) 4) patients whose glycemic control is very poor (HbA1c >=10%) 5) Pregnant women, women who may be pregnant, and breast-feeding women. 6) Patients with history of renal transplantation, urinary infection, sexually transmission disease, and non-cardiogenic stroke 7) Patients who took diuretics 8) patients whose BMI is lower than 18.5 9) Patients with history of acute coronary syndrome within 6 months 10) Patients judged by the investigator/ sub investigator to be ineligible for some other reason |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Anjo Kosei Hospital | ||||||
Division name | Cardiovascular Center | ||||||
Zip code | |||||||
Address | 28, Higashi-Hirokute, Anjo, Anjo, Aichi | ||||||
TEL | 0566-75-2111 | ||||||
watarai@kosei.anjo.aichi.jp |
Public contact | |||||||
Name of contact person |
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Organization | Anjo Kosei Hospital | ||||||
Division name | cardiovascular Center | ||||||
Zip code | |||||||
Address | 28, Higashi-Hirokute, Anjo, Anjo, Aichi | ||||||
TEL | 0566-75-2111 | ||||||
Homepage URL | |||||||
yusuke0307@hotmail.com |
Sponsor | |
Institute | Anjo Kosei Hospital, Cardiovascular Center |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
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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=R000019543 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |