An Extension Study of PEAK Trial (PEAK-E)
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|ClinicalTrials.gov Identifier: NCT02763007|
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: alogliptin+pioglitazone Drug: alogliptin Drug: pioglitazone||Phase 4|
PEAK trial is now undergoing (Multicenter, randomized, double blind, three-arm parallel group study to evaluate efficacy and safety of Alogliptin and Pioglitazone combination therapy on glucose control in type 2 diabetes subjects who have inadequate control with Metformin monotherapy in Korea, Takeda No. ALO-IIT-012).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients|
|Actual Study Start Date :||May 18, 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||September 2020|
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 and pioglitazone add on metformin
Other Name: nesina, actos
Active Comparator: 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
nesina add on metformin
Other Name: nesina
Active Comparator: 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
actos add on metformin
Other Name: actos
- Proportion of subjects achieving HbA1c <7% [ Time Frame: 36 months after randomization ]
- Proportion of subjects achieving HbA1c <6.5% [ Time Frame: 36 Months after randomization ]
- Proportion of subjects achieving HbA1c <7% [ Time Frame: 12 Months after randomization ]
- Comparing change of HbA1c on each group from the baseline. [ Time Frame: baseline, 12 months ]
- Comparing change of HOMA-IR(homeostasis model assessment of insulin resistance) on each group from the baseline. [ Time Frame: baseline, 36 months ]
- Comparing change of HOMA-beta on each group from the baseline. [ Time Frame: baseline, 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763007
|Contact: YOON-HEE CHOI, MD,PhDfirstname.lastname@example.org|
|Contact: Kun-Ho Yoon, MD, PhDemail@example.com|
|Korea, Republic of|
|Seoul St Mary's Hospital, The Catholic University of Korea||Recruiting|
|Seoul, Korea, Republic of, 137-701|
|Contact: YOON HEE CHOI, MD|
|Principal Investigator: Kun-Ho Yoon, MD, PhD|
|Sub-Investigator: Yoon-Hee Choi, MD, PhD|
|Sub-Investigator: Eun-Young Lee, MD, PhD|
|Principal Investigator:||Kun-Ho Yoon, MD, PhD||Seoul St Mary's Hospital, The Catholic University of Korea|