NCT02231021

Brief Summary

This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 diabetic patients in Korea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2014

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

Geographic Reach
1 country

1 active site

Status
completed

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

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

4.1 years

First QC Date

August 29, 2014

Last Update Submit

February 7, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2alogliptinpioglitazoneDPP4 inhibitorthiazolidinedione

Outcome Measures

Primary Outcomes (1)

  • Change in glycohemoglobin(HbA1c) from baseline

    baseline, 24 weeks

Secondary Outcomes (31)

  • Proportion of subjects achieving HbA1c < 7.0%

    24 week

  • Proportion of subjects achieving HbA1c <6.5%

    24 week

  • Changes in glycated albumin(GA) from baseline

    baseline, 24 weeks

  • Change in GA/HbA1c ratio from baseline

    baseline, 24 weeks

  • Change in fasting blood sugar from baseline

    baseline, 24 weeks

  • +26 more secondary outcomes

Study Arms (3)

alogliptin + pioglitazone

EXPERIMENTAL

alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll

Drug: alogliptin + pioglitazone

alogliptin

ACTIVE COMPARATOR

alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone matching placebo 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll

Drug: alogliptin

Pioglitazone

ACTIVE COMPARATOR

alogliptin matching placebo 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll

Drug: Pioglitazone

Interventions

alogliptinDRUG

alogliptin 25 mg add-on background medication metformin

Also known as: Nesina
alogliptin
PioglitazoneDRUG

pioglitazone 30 mg add-on background medication metformin

Also known as: actos
Pioglitazone
alogliptin + pioglitazoneDRUG

alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin

Also known as: Nesina, Actos
alogliptin + pioglitazone

Eligibility Criteria

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

You may qualify if:

  • In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements
  • The subject or, when applicable, the subject's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
  • The subjects diagnosed type 2 diabetes mellitus at least 6 months
  • Male and female and 19 to 75 years, inclusive
  • % =\<HbA1c =\<10.0%
  • Kg/m2 =\<Body Mass Index(BMI) =\<45 kg/m2
  • systolic/diastolic blood pressure =\<160/100 at baseline
  • hemoglobin of at least 12 g/dL for men and at least 10 g/dL for women
  • A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from singing of informed consent throughout the duration of the study
  • Patient who receiving maximal tolerated dose of metformin at least 12 weeks without dose change (for metformin, \>= 1,000 mg/day
  • fasting c-peptide greater than 0.78 ng/mL(0.26 nmol/L) at baseline

You may not qualify if:

  • The patient has received investigational compound(alogliptin or pioglitazone) within 180 days prior to baseline
  • Patient who currently taking or need to take andy medicine which may exert a significant influence on blood glucose control except metformin.
  • Severe renal disease : estimated glomerular filtration rate \<50 mL/min
  • Severe liver disease or AST, ALT \>= 2.5 upper limit of normal
  • Cardiac status : New York Heart Association III \~ IV
  • Hypopituitarism or adrenal insufficiency
  • Patient who has a history of major surgery, Severe infections, Severe traumas within 6 months
  • Patients who has diagnosed malignancy within 5yrs ,
  • Patients with active bladder cancer
  • Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Patient who has a history of hypersensitivity to Alogliptin, Pioglitazone or their ingredients
  • Pregnant or lactating woman
  • Patient who has history of excessive alcohol abuse
  • Subject who is involved in other clinical trial within 90 days prior to initiation of this study.
  • Subject who the investigator deems inappropriate to participate in this study

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 Univerisity of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 3, 2014

Study Start

September 1, 2014

Primary Completion

October 22, 2018

Study Completion

January 28, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)