Type 2 DiabetesPhase 3NCT05226897
Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
A Phase 3 study testing YYC405-T, Metformin≥1000mg and Dapagliflozin 10mg in people with Type 2 Diabetes, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- YYC405-T, Metformin≥1000mg and Dapagliflozin 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2021to 26 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea(Bucheon St. Mary's Hospital)
Bucheon-si
About this study
Official title: 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
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- YYC405-T, Metformin≥1000mg, Dapagliflozin 10mg, YYC405-T placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYC405-TDrug
Subjects take the investigational products once a day for 24 weeks.
Metformin≥1000mgDrug
Subjects take the investigational products once a day for 24 weeks.
Dapagliflozin 10mgDrug
Subjects take the investigational products once a day for 24 weeks.
YYC405-T placeboDrug
Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg Receives: Drug: YYC405-T; Drug: Metformin≥1000mg; Drug: Dapagliflozin 10mg |
| Placebo control | Placebo comparator | Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg Receives: Drug: Metformin≥1000mg; Drug: Dapagliflozin 10mg; Drug: YYC405-T placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Baseline, 24 weeks
Secondary outcomes (3)
HbA1c
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Baseline, 12weeks
FPG, Fasting insulin
Change from baseline in Fasing plasma glucose and Fasting insulin
Measured: Baseline, 12weeks, 24weeks
C-peptide
Change from baseline in C-peptide
Measured: Baseline, 12weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start12 Jul 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion26 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sungrae Kim, MD, Ph.D, Study chair, Bucheon St Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226897
- Sponsor's protocol ID
- YYPCT_YYC405_301
- Status last verified
- May 2022
- First submitted
- 17 Jan 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lim S, Lee SH, Min KW, Lee CB, Kim SY, Yoo HJ, Kim NH, Kim JH, Oh S, Won JC, Kwon HS, Kim MK, Park JH, Jeong IK, Kim S. A multicentre, double-blind, placebo-controlled, randomized, parallel comparison, phase 3 trial to evaluate the efficacy and safety of pioglitazone add-on therapy in type 2 diabetic patients treated with metformin and dapagliflozin. Diabetes Obes Metab. 2024 Jun;26(6):2188-2198. doi: 10.1111/dom.15526. Epub 2024 Feb 29.
PubMed 38425186
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05226897
- Acronym / sponsor ID
- YYPCT_YYC405_301
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 26 Jun 2023 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: YYC405-T, Drug: Metformin≥1000mg, Drug: Dapagliflozin 10mgTake YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg |
| Placebo control | Placebo comparator | Drug: Metformin≥1000mg, Drug: Dapagliflozin 10mg, Drug: YYC405-T placeboTake YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YYC405-TSubjects take the investigational products once a day for 24 weeks. | Drug | Test |
| Metformin≥1000mgSubjects take the investigational products once a day for 24 weeks. | Drug | Placebo control, Test |
| Dapagliflozin 10mgSubjects take the investigational products once a day for 24 weeks. | Drug | Placebo control, Test |
| YYC405-T placeboMicrocrystalline cellulose, Subjects take the investigational products once a day for 24 weeks. | Drug | Placebo control |
Primary outcome
HbA1c
Time frame: Baseline, 24 weeks
Change from baseline in Glycosylated Hemoglobin (HbA1c)
3 secondary outcomes
HbA1c
Time frame: Baseline, 12weeks
FPG, Fasting insulin
Time frame: Baseline, 12weeks, 24weeks
C-peptide
Time frame: Baseline, 12weeks, 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 38425186Lim S, Lee SH, Min KW, Lee CB, Kim SY, Yoo HJ, Kim NH, Kim JH, Oh S, Won JC, Kwon HS, Kim MK, Park JH, Jeong IK, Kim S. A multicentre, double-blind, placebo-controlled, randomized, parallel comparison, phase 3 trial to evaluate the efficacy and safety of pioglitazone add-on therapy in type 2 diabetic patients treated with metformin and dapagliflozin. Diabetes Obes Metab. 2024 Jun;26(6):2188-2198. doi: 10.1111/dom.15526. Epub 2024 Feb 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sungrae Kim, MD, Ph.D study chair
Bucheon St Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YYC405-T, Metformin≥1000mg and Dapagliflozin 10mg in people with Type 2 Diabetes, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.