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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TERMINATED
PHASE4
41 participants
INTERVENTIONAL
2016-05-18
2019-02-28
Brief Summary
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Detailed Description
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Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.
Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.
PEAK trial will be followed by another 28 week open-label treatment of the same drug as initial randomization (total duration of treatment as randomized 52 week), and followed by 2 year of observation.
During observation period, any antidiabetic medication can be added/changed when HbA1c of the subject is off target 7% with clinician's clinical decision.
After 3 years of initial randomization, durability of glucose control will be assessed between 3 treatment group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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alogliptin+pioglitazone
A group who treat with alogliptin+pioglitazone: The Combination of Alogliptin 25 mg and pioglitazone 30 mg daily add on metformin for 28 week as extension and followed by 2 years of observation
alogliptin+pioglitazone
alogliptin and pioglitazone add on metformin
alogliptin
A group who treat with alogliptin: Alogliptin 25 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation
alogliptin
nesina add on metformin
pioglitazone
A group who treat with pioglitazone: Pioglitazone 30 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation
pioglitazone
actos add on metformin
Interventions
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alogliptin+pioglitazone
alogliptin and pioglitazone add on metformin
alogliptin
nesina add on metformin
pioglitazone
actos add on metformin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male, or female, 19 years to 75 years.
* Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study
* Subjects completed PEAK can be included within 30 days after End Of the Study
* Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.
Exclusion Criteria
* AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) \>2.5 upper limit of normal
* Pregnant or lactating women
* Subject who the investigator deems inappropriate to participate in this study
* Patients with a history of bladder cancer or patients with active bladder cancer
* Patients with uninvestigated macroscopic hematuria
* Patients with cardiac failure or a history of cardiac failure (New York Heart Association \[NYHA\] Stages 3 to 4)
* Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this study drug contains lactose
19 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Kun-Ho Yoon
OTHER
Responsible Party
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Kun-Ho Yoon
professor
Principal Investigators
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Kun-Ho Yoon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul St Mary's Hospital, The Catholic University of Korea
Locations
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Seoul St Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Countries
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Other Identifiers
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PEAK-E
Identifier Type: -
Identifier Source: org_study_id
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