The Efficacy and Safety of D745 Added to D150 Plus D759 T... | NCT05566028

Studies
The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 Diabetes

NCT05566028

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

Dec 10, 2024Actual

Enrollment

172Actual

Phase

Phase 3

Conditions

Type 2 Diabetes

Interventions

D745 formulation I
D745 formulation II
D745 Placebo

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2022Actual

Primary Completion Date

Jan 10, 2024Actual

Completion Date

Jul 23, 2024Actual

First Submitted Date

Sep 30, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 4, 2022Actual

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

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

Detailed Description

The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

172Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Expermental group 1	Experimental	Pateints assigned to this group are treated with D150, D759 and D745 formulation I	Drug: D745 formulation I
Experimental group 2	Experimental	Pateints assigned to this group are treated with D150, D759 and D745 formulation II	Drug: D745 formulation II
Placebo group	Placebo Comparator	Pateints assigned to this group are treated with D150, D759 and D745 placebo	Drug: D745 Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D745 formulation I	Drug	QD for 24 weeks or 52 weeks(if extension study) with D150 and D759	Expermental group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c		Baseline, 24 week

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c		Baseline, 12 week
Change from baseline in Fasting plasma glucose		Baseline, 12 week, 24 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

between 19 years and 85 years old(male or female)
Type 2 diabetes mellitus
BMI between 18.5kg/m2 and 40kg/m2
Agreement with written informed consent

Exclusion Criteria:

Type 1 diabetes mellitus or secondary diabetes mellitus
Patients with complications of severe diabetes such as proliferative diabetic retinopathy
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Patients with abnormal laboratory test results according to the protocol
Continuous or non continuous treatment insulin within 12 weeks prior to screening
Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Youngmin Cho, M.D, Ph.D	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Jongno-gu	03080	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
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided