| Trial ID: | L6275 |
| Source ID: | NCT02763007
|
| Associated Drug: |
Alogliptin+Pioglitazone
|
| Title: |
An Extension Study of PEAK Trial
|
| Acronym: |
PEAK-E
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: alogliptin+pioglitazone|DRUG: alogliptin|DRUG: pioglitazone
|
| Outcome Measures: |
Primary: Proportion of subjects achieving HbA1c <7% after 36 month treatment, The proportion of subjects achieving HbA1c on target \< 7.0% after 36 month., 36 months after randomization | Secondary: Proportion of subjects achieving HbA1c <6.5% after 36 month treatment, The proportion of subjects achieving HbA1c on target \< 6.5% after 36 month., 36 Months after randomization|Proportion of subjects achieving HbA1c <7% after 12 month treatment, The proportion of subjects achieving HbA1c on target \< 7.0% after 12 month., 12 Months after randomization|Change in glycated hemoglobin(HbA1c) from baseline to 12 month, Change from baseline in HbA1c after 6 month of double blinded treatment followed by 6 month open treatment, baseline, 12 months|Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month, Change from baseline in HOMA-IR(homeostasis model assessment of insulin resistance) after 12 month of randomized treatment followed by 24 month observation., baseline, 36 months|change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month, Change from baseline in HOMA-beta(homeostasis model assessment of beta cell) after 12 month of randomized treatment followed by 24 month observation., baseline, 36 months
|
| Sponsor/Collaborators: |
Sponsor: Kun-Ho Yoon | Collaborators: Takeda
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-05-18
|
| Completion Date: |
2019-02-28
|
| Results First Posted: |
|
| Last Update Posted: |
2019-06-05
|
| Locations: |
Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, 137-701, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02763007
|
