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

NCT ID: NCT05566028

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2024-07-23

Brief Summary

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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

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Expermental group 1

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

Group Type EXPERIMENTAL

D745 formulation I

Intervention Type DRUG

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Experimental group 2

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

Group Type EXPERIMENTAL

D745 formulation II

Intervention Type DRUG

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Placebo group

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

Group Type PLACEBO_COMPARATOR

D745 Placebo

Intervention Type DRUG

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Interventions

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D745 formulation I

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Intervention Type DRUG

D745 formulation II

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Intervention Type DRUG

D745 Placebo

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Youngmin Cho, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A127_02DM2210

Identifier Type: -

Identifier Source: org_study_id