Type 2 DiabetesPhase 3NCT05566028
The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 Diabetes
A Phase 3 study testing D745 formulation I and D745 formulation II in people with Type 2 Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- D745 formulation I and D745 formulation II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Oct 2022to 23 Jul 2024
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: 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
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
- Conditions
- Type 2 Diabetes
- Being tested
- D745 formulation I, D745 formulation II, D745 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.
D745 formulation IDrug
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
D745 formulation IIDrug
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
D745 PlaceboDrug
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
| Study group | Role | What they receive |
|---|---|---|
| Expermental group 1 | Experimental | Pateints assigned to this group are treated with D150, D759 and D745 formulation I Receives: Drug: D745 formulation I |
| Experimental group 2 | Experimental | Pateints assigned to this group are treated with D150, D759 and D745 formulation II Receives: Drug: D745 formulation II |
| Placebo group | Placebo comparator | Pateints assigned to this group are treated with D150, D759 and D745 placebo Receives: Drug: D745 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: Baseline, 24 week
Secondary outcomes (2)
Change from baseline in HbA1c
Measured: Baseline, 12 week
Change from baseline in Fasting plasma glucose
Measured: Baseline, 12 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start12 Oct 2022
- Primary completion10 Jan 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Youngmin Cho, M.D, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566028
- Sponsor's protocol ID
- A127_02DM2210
- Status last verified
- Dec 2024
- First submitted
- 30 Sep 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05566028
- Acronym / sponsor ID
- A127_02DM2210
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 4 Oct 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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expermental group 1 | Experimental | Drug: D745 formulation IPateints assigned to this group are treated with D150, D759 and D745 formulation I |
| Experimental group 2 | Experimental | Drug: D745 formulation IIPateints assigned to this group are treated with D150, D759 and D745 formulation II |
| Placebo group | Placebo comparator | Drug: D745 PlaceboPateints assigned to this group are treated with D150, D759 and D745 placebo |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| D745 formulation IQD for 24 weeks or 52 weeks(if extension study) with D150 and D759 | Drug | Expermental group 1 |
| D745 formulation IIQD for 24 weeks or 52 weeks(if extension study) with D150 and D759 | Drug | Experimental group 2 |
| D745 PlaceboQD for 24 weeks or 52 weeks(if extension study) with D150 and D759 | Drug | Placebo group |
Primary outcome
Change from baseline in HbA1c
Time frame: Baseline, 24 week
2 secondary outcomes
Change from baseline in HbA1c
Time frame: Baseline, 12 week
Change from baseline in Fasting plasma glucose
Time frame: Baseline, 12 week, 24 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Youngmin Cho, M.D, Ph.D principal investigator
Seoul National University 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 D745 formulation I and D745 formulation II in people with Type 2 Diabetes, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in HbA1c (time frame: Baseline, 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.