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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05566028
Enrollment
172
Registered
2022-10-04
Start date
2022-10-12
Completion date
2024-07-23
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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

Interventions

DRUGD745 formulation I

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

DRUGD745 formulation II

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

DRUGD745 Placebo

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

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1cBaseline, 24 week

Secondary

MeasureTime frame
Change from baseline in HbA1cBaseline, 12 week
Change from baseline in Fasting plasma glucoseBaseline, 12 week, 24 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026