NCT02763007

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started May 2016

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 18, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

2.6 years

First QC Date

April 29, 2016

Last Update Submit

June 3, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Proportion of subjects achieving HbA1c <6.5% after 36 month treatment

    36 Months after randomization

  • Proportion of subjects achieving HbA1c <7% after 12 month treatment

    12 Months after randomization

  • Change in glycated hemoglobin(HbA1c) from baseline to 12 month

    baseline, 12 months

  • Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month

    baseline, 36 months

  • change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month

    baseline, 36 months

Study Arms (3)

alogliptin+pioglitazone

EXPERIMENTAL

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

Drug: alogliptin+pioglitazone

alogliptin

ACTIVE COMPARATOR

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

Drug: alogliptin

pioglitazone

ACTIVE COMPARATOR

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

Drug: pioglitazone

Interventions

alogliptin+pioglitazoneDRUG

alogliptin and pioglitazone add on metformin

Also known as: nesina, actos
alogliptin+pioglitazone
alogliptinDRUG

nesina add on metformin

Also known as: nesina
alogliptin
pioglitazoneDRUG

actos add on metformin

Also known as: actos
pioglitazone

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptinPioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kun-Ho Yoon, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 5, 2016

Study Start

May 18, 2016

Primary Completion

December 19, 2018

Study Completion

February 28, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)