Effect of Alogliptin/Pioglitazone on the Preservation of... | NCT02823808

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

NCT02823808

Sponsor

Kyunghee University Medical Center

Status

Unknown status

Last Update Posted

Jul 25, 2017Actual

Enrollment

96Estimated

Phase

Phase 4

Conditions

Diabetes

Interventions

NESINA ACT TAB. 25/15mg
AMARYL-M TAB. 2/500mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Jul 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jul 1, 2016

First Submission Date that Met QC Criteria

Jul 1, 2016

First Posted Date

Jul 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2017

Last Update Posted Date

Jul 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeong-taek Woo, Professor, Kyunghee University Medical CenterPrincipal Investigator

Lead Sponsor

Kyunghee University Medical CenterOTHER

Collaborators

Name	Class
Takeda	INDUSTRY
Kyung Hee University Hospital at Gangdong	OTHER
Bucheon St. Mary's Hospital	OTHER
Korea University Guro Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NESINA ACT TAB. 25/15mg	Drug	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c		104 weeks from randomization
Change in Fasting Blood Sugar		104 weeks from randomization
Change in Glycoalbumin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeong-taek Woo	Contact	822-958-8200		jtwoomd@khmc.or.kr
Sang Youl Rhee	Contact	822-958-8200		bard95@hanmail.net

Overall Officials

Name	Affiliation	Role
Jeong-taek Woo	Kyung Hee University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyunghee University Medical Center	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided