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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D745 formulation I
D745 formulation II
D745 Placebo
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Expermental group 1

Experimental group 2

Placebo group

Arm Description

Pateints assigned to this group are treated with D150, D759 and D745 formulation I

Pateints assigned to this group are treated with D150, D759 and D745 formulation II

Pateints assigned to this group are treated with D150, D759 and D745 placebo

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Change from baseline in HbA1c
Change from baseline in Fasting plasma glucose

Full Information

First Posted
September 30, 2022
Last Updated
September 30, 2022
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05566028
Brief Title
The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes
Official Title
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints With Type 2 Diabetes Inadequately Controlled With D150 Plus D759
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
April 16, 2024 (Anticipated)
Study Completion Date
October 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expermental group 1
Arm Type
Experimental
Arm Description
Pateints assigned to this group are treated with D150, D759 and D745 formulation I
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Pateints assigned to this group are treated with D150, D759 and D745 formulation II
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Pateints assigned to this group are treated with D150, D759 and D745 placebo
Intervention Type
Drug
Intervention Name(s)
D745 formulation I
Intervention Description
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
Intervention Type
Drug
Intervention Name(s)
D745 formulation II
Intervention Description
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
Intervention Type
Drug
Intervention Name(s)
D745 Placebo
Intervention Description
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, 24 week
Secondary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, 12 week
Title
Change from baseline in Fasting plasma glucose
Time Frame
Baseline, 12 week, 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngmin Cho, M.D, Ph.D
Phone
+8202-2072-1965
Email
ymchomd@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngmin Cho, M.D, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngmin Cho, M.D, Ph.D
Phone
+82-2-2072-1865
Email
ymchomd@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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