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Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function

NCT02823808 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-07-25

No results posted yet for this study

Summary

All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol.

* All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks.
* Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.

Conditions

Interventions

DRUG

NESINA ACT TAB. 25/15mg

Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.

DRUG

AMARYL-M TAB. 2/500mg

Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER

  • Bucheon St. Mary's Hospital

    collaborator OTHER

  • Korea University Guro Hospital

    collaborator OTHER

  • Ajou University School of Medicine

    collaborator OTHER

  • Inha University Hospital

    collaborator OTHER

  • Kangbuk Samsung Hospital

    collaborator OTHER

  • Seoul Medical Center

    collaborator OTHER

  • Kyunghee University Medical Center

    lead OTHER

Principal Investigators

  • Jeong-taek Woo · Kyung Hee University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
26 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2021-07-31
Completion
2021-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02823808 on ClinicalTrials.gov