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CompletedNCT05566028Updated Dec 10, 2024

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

A Phase 3 interventional study of D745 formulation I and D745 formulation II in Type 2 Diabetes, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 172 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
172 participants (actual)

Study arms

  • Experimental
    Expermental group 1

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

    Drug: D745 formulation I

  • Experimental
    Experimental group 2

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

    Drug: D745 formulation II

  • Placebo comparator
    Placebo group

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

    Drug: D745 Placebo

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline, 24 week

Secondary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline, 12 week

  2. Change from baseline in Fasting plasma glucose

    Time frame: Baseline, 12 week, 24 week

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Jongno-gu 03080, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05566028
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Oct 12, 2022
Primary completion
Jan 10, 2024
Completion
Jul 23, 2024
Last update
Dec 10, 2024

Study contacts

Youngmin Cho, M.D, Ph.D
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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