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An Extension Study of PEAK Trial (PEAK-E)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
alogliptin+pioglitazone
alogliptin
pioglitazone
Sponsored by
Kun-Ho Yoon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St Mary's Hospital, The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

alogliptin+pioglitazone

alogliptin

pioglitazone

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Proportion of subjects achieving HbA1c <7% after 36 month treatment
The proportion of subjects achieving HbA1c on target < 7.0% after 36 month.

Secondary Outcome Measures

Proportion of subjects achieving HbA1c <6.5% after 36 month treatment
The proportion of subjects achieving HbA1c on target < 6.5% after 36 month.
Proportion of subjects achieving HbA1c <7% after 12 month treatment
The proportion of subjects achieving HbA1c on target < 7.0% after 12 month.
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
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.
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.

Full Information

First Posted
April 29, 2016
Last Updated
June 3, 2019
Sponsor
Kun-Ho Yoon
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02763007
Brief Title
An Extension Study of PEAK Trial
Acronym
PEAK-E
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
difficulty in recruiting patients
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kun-Ho Yoon
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alogliptin+pioglitazone
Arm Type
Experimental
Arm Description
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
Arm Title
alogliptin
Arm Type
Active Comparator
Arm Description
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
Arm Title
pioglitazone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
alogliptin+pioglitazone
Other Intervention Name(s)
nesina, actos
Intervention Description
alogliptin and pioglitazone add on metformin
Intervention Type
Drug
Intervention Name(s)
alogliptin
Other Intervention Name(s)
nesina
Intervention Description
nesina add on metformin
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
actos
Intervention Description
actos add on metformin
Primary Outcome Measure Information:
Title
Proportion of subjects achieving HbA1c <7% after 36 month treatment
Description
The proportion of subjects achieving HbA1c on target < 7.0% after 36 month.
Time Frame
36 months after randomization
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving HbA1c <6.5% after 36 month treatment
Description
The proportion of subjects achieving HbA1c on target < 6.5% after 36 month.
Time Frame
36 Months after randomization
Title
Proportion of subjects achieving HbA1c <7% after 12 month treatment
Description
The proportion of subjects achieving HbA1c on target < 7.0% after 12 month.
Time Frame
12 Months after randomization
Title
Change in glycated hemoglobin(HbA1c) from baseline to 12 month
Description
Change from baseline in HbA1c after 6 month of double blinded treatment followed by 6 month open treatment
Time Frame
baseline, 12 months
Title
Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month
Description
Change from baseline in HOMA-IR(homeostasis model assessment of insulin resistance) after 12 month of randomized treatment followed by 24 month observation.
Time Frame
baseline, 36 months
Title
change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month
Description
Change from baseline in HOMA-beta(homeostasis model assessment of beta cell) after 12 month of randomized treatment followed by 24 month observation.
Time Frame
baseline, 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun-Ho Yoon, MD, PhD
Organizational Affiliation
Seoul St Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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An Extension Study of PEAK Trial

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