Brief 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.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline

Completed

Started Jul 2017

Longer than P75 for phase_4 diabetes

Geographic Reach

1 country

1 active site

Status

unknown

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

4.4 years study duration

First Submitted

Initial submission to the registry

July 1, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed

12 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed

Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

July 1, 2016

Last Update Submit

July 21, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control
104 weeks from randomization

Secondary Outcomes (7)

Change in HbA1c
104 weeks from randomization
Change in Fasting Blood Sugar
104 weeks from randomization
Change in Glycoalbumin
104 weeks from randomization
Change in insulin sensitivity (HOMA2%S)
104 weeks from randomization
Change in insulin sensitivity (HOMA2%B)
104 weeks from randomization
+2 more secondary outcomes

Study Arms (2)

ALO+PIO

EXPERIMENTAL

Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily.

Drug: NESINA ACT TAB. 25/15mg

GMPD+MET

ACTIVE COMPARATOR

Group who takes Glimepiride 2mg+Metformin 500mg, once daily.

Drug: AMARYL-M TAB. 2/500mg

Interventions

NESINA ACT TAB. 25/15mgDRUG

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

ALO+PIO

AMARYL-M TAB. 2/500mgDRUG

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

GMPD+MET

Eligibility Criteria

Age26 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 Diabetes Mellitus patients
Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy

You may not qualify if:

The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
The use of insulin within the 3 months prior to screening
Others

Contact the study team to confirm eligibility.

Study Sites (1)

Kyunghee University Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Jeong-taek Woo
Kyung Hee University Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-taek Woo

CONTACT

822-958-8200 jtwoomd@khmc.or.kr

Sang Youl Rhee

CONTACT

822-958-8200 bard95@hanmail.net

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: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 6, 2016

Study Start

July 1, 2017

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

July 25, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing: Will not share

Locations

KR(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

ALO+PIO

GMPD+MET

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

ALO+PIO

GMPD+MET

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations