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

May 30, 2022 updated by: Yooyoung Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • The Catholic University of Korea(Bucheon St. Mary's Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test
Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Drug: Metformin≥1000mg
Subjects take the investigational products once a day for 24 weeks.
Drug: Dapagliflozin 10mg
Subjects take the investigational products once a day for 24 weeks.
Drug: YYC405-T
Subjects take the investigational products once a day for 24 weeks.
PLACEBO_COMPARATOR: Placebo control
Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
Drug: Metformin≥1000mg
Subjects take the investigational products once a day for 24 weeks.
Drug: Dapagliflozin 10mg
Subjects take the investigational products once a day for 24 weeks.
Drug: YYC405-T placebo
Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline, 24 weeks
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline, 12weeks
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Baseline, 12weeks
FPG, Fasting insulin
Time Frame: Baseline, 12weeks, 24weeks
Change from baseline in Fasing plasma glucose and Fasting insulin
Baseline, 12weeks, 24weeks
C-peptide
Time Frame: Baseline, 12weeks, 24weeks
Change from baseline in C-peptide
Baseline, 12weeks, 24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Sungrae Kim, MD, Ph.D, Bucheon St Mary Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2021

Primary Completion (ANTICIPATED)

October 31, 2022

Study Completion (ANTICIPATED)

June 26, 2023

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (ACTUAL)

February 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYPCT_YYC405_301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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