Diabetes MellitusPhase 1NCT02302443
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470
A Phase 1 study testing HM12470 and Active comparator in people with Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HM12470 and Active comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to May 2017
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM more than 12 monthM
- Age ≥18 and ≤70 years
- Body mass index between 18.0 and 35.0 kg/m2 inclusive.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
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- T1DM more than 12 monthM
- Age ≥18 and ≤70 years
- Body mass index between 18.0 and 30.0 kg/m2 inclusive.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
Who cannot join
- A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
- pregnant or lactating women
- participation in an investigational study within 30 days prior to dosing
- Clinically significant abnormal ECG at screening, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Administration of HM12470 in Subjects With Type 1 (T1DM) and Type 2 Diabetes Mellitus (T2DM)
The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
Read the detailed description
This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.
- Conditions
- Diabetes Mellitus
- Being tested
- HM12470, Active comparator
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM12470Biological
Single dose subcutaneous administration ranging from a very low dose to high dose
Active comparatorBiological
Single dose subcutaneous administration of active comparator
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Very low dose of HM12470 (single dose, subcutaneous injection) Receives: Biological: HM12470 |
| Cohort 2 | Experimental | Low dose of HM12470 (single dose, subcutaneous injection) Receives: Biological: HM12470 |
| Cohort 3 | Experimental | Intermediate dose of HM12470 (single dose, subcutaneous injection) Receives: Biological: HM12470 |
| Cohort 4 | Experimental | High dose of HM12470 (single dose, subcutaneous injection) Receives: Biological: HM12470 |
| Cohort 5 | Experimental | Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection) Receives: Biological: HM12470; Biological: Active comparator |
| Cohort 6 | Experimental | Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection) Receives: Biological: HM12470; Biological: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events
Measured: 1 month
Secondary outcomes (2)
Peak Plasma Concentration(Cmax) of HM12470 following a single dose
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
Measured: 1 month
Area under the concentration-time curve (AUC) of HM12470 following a single dose
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmi Pharmaceuticals Hanmi Pharmaceuticals, Study director, Hanmi Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302443
- Sponsor's protocol ID
- HM-INS115-101
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Administration of HM12470 in Subjects With Type 1 (T1DM) and Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT02302443
- Acronym / sponsor ID
- HM-INS115-101
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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 investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
Detailed description
This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: HM12470Very low dose of HM12470 (single dose, subcutaneous injection) |
| Cohort 2 | Experimental | Biological: HM12470Low dose of HM12470 (single dose, subcutaneous injection) |
| Cohort 3 | Experimental | Biological: HM12470Intermediate dose of HM12470 (single dose, subcutaneous injection) |
| Cohort 4 | Experimental | Biological: HM12470High dose of HM12470 (single dose, subcutaneous injection) |
| Cohort 5 | Experimental | Biological: HM12470, Biological: Active comparatorActive comparator and a selected dose of HM12470 (single dose, subcutaneous injection) |
| Cohort 6 | Experimental | Biological: HM12470, Biological: Active comparatorActive comparator and a selected dose of HM12470 (single dose, subcutaneous injection) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- T2DM more than 12 monthM
- Age ≥18 and ≤70 years
- Body mass index between 18.0 and 35.0 kg/m2 inclusive.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
Key exclusion criteria (5 listed)
- A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
- pregnant or lactating women
- participation in an investigational study within 30 days prior to dosing
- Clinically significant abnormal ECG at screening, as judged by the Investigator
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 |
|---|---|---|
| HM12470Single dose subcutaneous administration ranging from a very low dose to high dose | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| Active comparatorSingle dose subcutaneous administration of active comparator | Biological | Cohort 5, Cohort 6 |
Primary outcome
Incidence and severity of treatment emergent adverse events
Time frame: 1 month
2 secondary outcomes
Peak Plasma Concentration(Cmax) of HM12470 following a single dose
Time frame: 1 month
Area under the concentration-time curve (AUC) of HM12470 following a single dose
Time frame: 1 month
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 8 Nov 2017.
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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.
Hanmi Pharmaceuticals Hanmi Pharmaceuticals study director
Hanmi Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM12470 and Active comparator in people with Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited 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 12 inclusion and 5 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 8 Nov 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence and severity of treatment emergent adverse events (time frame: 1 month). 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 8 Nov 2017.