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
1 other identifier
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedStudy Start
First participant enrolled
October 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2024
CompletedDecember 10, 2024
December 1, 2024
1.2 years
September 30, 2022
December 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
Baseline, 24 week
Secondary Outcomes (2)
Change from baseline in HbA1c
Baseline, 12 week
Change from baseline in Fasting plasma glucose
Baseline, 12 week, 24 week
Study Arms (3)
Expermental group 1
EXPERIMENTALPateints assigned to this group are treated with D150, D759 and D745 formulation I
Experimental group 2
EXPERIMENTALPateints assigned to this group are treated with D150, D759 and D745 formulation II
Placebo group
PLACEBO COMPARATORPateints assigned to this group are treated with D150, D759 and D745 placebo
Interventions
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youngmin Cho, M.D, Ph.D
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2022
First Posted
October 4, 2022
Study Start
October 12, 2022
Primary Completion
January 10, 2024
Study Completion
July 23, 2024
Last Updated
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share