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Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of YYC405-T Added to Metformin and Dapagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With the Combination of Metformin and Dapagliflozin

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05226897
Enrollment
256
Registered
2022-02-07
Start date
2021-07-12
Completion date
2023-06-26
Last updated
2022-06-01

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

Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Detailed description

Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Interventions

DRUGYYC405-T

Subjects take the investigational products once a day for 24 weeks.

DRUGMetformin≥1000mg

Subjects take the investigational products once a day for 24 weeks.

DRUGDapagliflozin 10mg

Subjects take the investigational products once a day for 24 weeks.

DRUGYYC405-T placebo

Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.

Sponsors

Yooyoung Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Intervention model description

a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient who contsent to participate in this tiral by written informed consent form * A man or woman over 20 years old * Type 2 Diabetes patients

Exclusion criteria

* Patients with severe renal impairment, end-stage renal disease or on dialysis * Type 1 diabetes patients * Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis

Design outcomes

Primary

MeasureTime frameDescription
HbA1cBaseline, 24 weeksChange from baseline in Glycosylated Hemoglobin (HbA1c)

Secondary

MeasureTime frameDescription
HbA1cBaseline, 12weeksChange from baseline in Glycosylated Hemoglobin (HbA1c)
FPG, Fasting insulinBaseline, 12weeks, 24weeksChange from baseline in Fasing plasma glucose and Fasting insulin
C-peptideBaseline, 12weeks, 24weeksChange from baseline in C-peptide

Countries

South Korea

Outcome results

None listed

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