Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function
NCT ID: NCT02823808
Last Updated: 2017-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
96 participants
INTERVENTIONAL
2017-07-31
2021-12-31
Brief Summary
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* All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks.
* Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALO+PIO
Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily.
NESINA ACT TAB. 25/15mg
Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
GMPD+MET
Group who takes Glimepiride 2mg+Metformin 500mg, once daily.
AMARYL-M TAB. 2/500mg
Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
Interventions
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NESINA ACT TAB. 25/15mg
Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
AMARYL-M TAB. 2/500mg
Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
Eligibility Criteria
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Inclusion Criteria
* Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy
Exclusion Criteria
* Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
* The use of insulin within the 3 months prior to screening
* Others
26 Years
70 Years
ALL
No
Sponsors
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Kyunghee University Medical Center
OTHER
Takeda
INDUSTRY
Kyung Hee University Hospital at Gangdong
OTHER
Bucheon St. Mary's Hospital
OTHER
Korea University Guro Hospital
OTHER
Ajou University School of Medicine
OTHER
Inha University Hospital
OTHER
Kangbuk Samsung Hospital
OTHER
Seoul Medical Center
OTHER
Responsible Party
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Jeong-taek Woo
Professor
Principal Investigators
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Jeong-taek Woo
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital
Locations
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Kyunghee University Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang Youl Rhee
Role: primary
Other Identifiers
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KNDP_IIT_2016_01
Identifier Type: -
Identifier Source: org_study_id
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