Type 2 Diabetes Mellitus (T2DM)Phase 2HDNO-1605NCT06647550
To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
A Phase 2 study testing HD-6277 100mg, HD-6277 50mg and HD-6277 25mg in people with Type 2 Diabetes Mellitus (T2DM), run by Hyundai Pharm at 1 site in South Korea.
Trial summary
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- HD-6277 100mg, HD-6277 50mg and HD-6277 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening.
Who cannot join
- Type 1 diabetes or another immune-mediated diabetes syndrome
- BMI: > 40 kg/m2
- C-peptide: < 0.5ng/mL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul
Sin-Gon Kim, PhD, k50367@korea.ac.kr
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Read the detailed description
This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.
This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- HD-6277 100mg, HD-6277 50mg, HD-6277 25mg, 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.
HD-6277 100mgDrug
PO, QD
HD-6277 50mgDrug
PO, QD
HD-6277 25mgDrug
PO, QD
PlaceboDrug
PO, QD
| Study group | Role | What they receive |
|---|---|---|
| HD-6277 100mg tab | Experimental | Oral tablet Receives: Drug: HD-6277 100mg |
| HD-6277 50mg tab | Experimental | Oral tablet Receives: Drug: HD-6277 50mg |
| HD-6277 25mg tab | Experimental | Oral tablet Receives: Drug: HD-6277 25mg |
| Placebo | Placebo comparator | Oral tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c at weeks 12 from baseline
change in HbA1c at weeks 12 from baseline
Measured: at weeks 12 from baseline
Secondary outcomes (4)
change in HbA1c at weeks 6 from baseline
change in HbA1c at weeks 6 from baseline
Measured: at weeks 6 from baseline
percentage of subjects with HbA1c level below 7.0% at weeks 12
percentage of subjects with HbA1c level below 7.0% at weeks 12
Measured: at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
Measured: at weeks 12
change in Glycoalbumin at weeks 6 and 12 from baseline
change in Glycoalbumin at weeks 6 and 12 from baseline
Measured: at weeks 6 and 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start12 Dec 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647550
- Sponsor's protocol ID
- HT-006-04
- Acronym
- HDNO-1605
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
- ClinicalTrials.gov ID
- NCT06647550
- Acronym / sponsor ID
- HDNO-1605 / HT-006-04
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hyundai PharmIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 2024 (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.
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Detailed description
This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.
This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HD-6277 100mg tab | Experimental | Drug: HD-6277 100mgOral tablet |
| HD-6277 50mg tab | Experimental | Drug: HD-6277 50mgOral tablet |
| HD-6277 25mg tab | Experimental | Drug: HD-6277 25mgOral tablet |
| Placebo | Placebo comparator | Drug: PlaceboOral tablet |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening.
Key exclusion criteria (3 listed)
- Type 1 diabetes or another immune-mediated diabetes syndrome
- BMI: > 40 kg/m2
- C-peptide: < 0.5ng/mL
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 |
|---|---|---|
| HD-6277 100mgPO, QD | Drug | HD-6277 100mg tab |
| HD-6277 50mgPO, QD | Drug | HD-6277 50mg tab |
| HD-6277 25mgPO, QD | Drug | HD-6277 25mg tab |
| PlaceboPO, QD | Drug | Placebo |
Primary outcome
change in HbA1c at weeks 12 from baseline
Time frame: at weeks 12 from baseline
change in HbA1c at weeks 12 from baseline
4 secondary outcomes
change in HbA1c at weeks 6 from baseline
Time frame: at weeks 6 from baseline
percentage of subjects with HbA1c level below 7.0% at weeks 12
Time frame: at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
Time frame: at weeks 12
change in Glycoalbumin at weeks 6 and 12 from baseline
Time frame: at weeks 6 and 12 from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HD-6277 100mg, HD-6277 50mg and HD-6277 25mg in people with Type 2 Diabetes Mellitus (T2DM), run by Hyundai Pharm 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 1 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: looking for participants now, as of the sponsor's last update on 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sin Gon Kim Korea University Anam Hospital, PhD (+82 1577-0083, k50367@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in HbA1c at weeks 12 from baseline (time frame: at weeks 12 from baseline). 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 13 Dec 2024.