Clinical trial NCT02763007: An Extension Study of PEAK Trial
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2016-05-05
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.
* 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:

* eGFR(Epidermal growth factor receptor) \< 50mL/min
* 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

Primary outcomes:
measure: Proportion of subjects achieving HbA1c <7% after 36 month treatment
timeFrame: 36 months after randomization
Secondary outcomes:
measure: Proportion of subjects achieving HbA1c <6.5% after 36 month treatment
timeFrame: 36 Months after randomization
measure: Proportion of subjects achieving HbA1c <7% after 12 month treatment
timeFrame: 12 Months after randomization
measure: Change in glycated hemoglobin(HbA1c) from baseline to 12 month
timeFrame: baseline, 12 months
measure: Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month
timeFrame: baseline, 36 months
measure: change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month
timeFrame: baseline, 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Seoul St Mary's Hospital, The Catholic University of Korea
name: Kun-Ho Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: