Type1 Diabetes MellitusPhase 1NCT03332849
Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus
A Phase 1 study testing HM12470 in people with Type1 Diabetes Mellitus and Type2 Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type1 Diabetes Mellitus, Type2 Diabetes Mellitus
- What is being tested?
- HM12470
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2015to 30 Apr 2018
- 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
- T1DM or T2DM
- Female subjects must be non-pregnant and non-lactating
Who cannot join
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to dosing
Trial locations and contacts
1 site in 1 country.
United States1 site
Hanmi Investigative Site
Chula Vista, California, 91911
About this study
Official title: A Phase 1, Multiple Ascending Dose Glucose Clamp Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470 in Comparison to Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes Mellitus
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus
- Conditions
- Type1 Diabetes Mellitus, Type2 Diabetes Mellitus
- Being tested
- HM12470
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM12470Biological
HM12470 is a long-acting insulin analogue
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | T1DM: Multiple dose subcutaneous administration Receives: Biological: HM12470 |
| Cohort 2 | Experimental | T1DM: Multiple dose subcutaneous administration Receives: Biological: HM12470 |
| Cohort 3 | Experimental | T2DM: Multiple dose subcutaneous administration Receives: Biological: HM12470 |
| Cohort 4 | Experimental | T2DM: Multiple dose subcutaneous administration Receives: Biological: HM12470 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products.
Measured: 1 month
Secondary outcomes (2)
Cmax of HM12470
- Maximum concentration of HM12470 over the entire dosing period
Measured: 1 month
AUC of HM12470
- Area Under the Curve of HM12470 over the entire dosing period
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 posted6 Nov 2017
- Study start28 Jul 2015
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332849
- Sponsor's protocol ID
- HM-INS115-103
- Status last verified
- Nov 2017
- First submitted
- 26 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple Ascending Dose Glucose Clamp Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470 in Comparison to Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03332849
- Acronym / sponsor ID
- HM-INS115-103
- Conditions
- Type1 Diabetes Mellitus, Type2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 6 Nov 2017 (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.
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: HM12470T1DM: Multiple dose subcutaneous administration |
| Cohort 2 | Experimental | Biological: HM12470T1DM: Multiple dose subcutaneous administration |
| Cohort 3 | Experimental | Biological: HM12470T2DM: Multiple dose subcutaneous administration |
| Cohort 4 | Experimental | Biological: HM12470T2DM: Multiple dose subcutaneous administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- T1DM or T2DM
- Female subjects must be non-pregnant and non-lactating
Key exclusion criteria (2 listed)
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to dosing
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 |
|---|---|---|
| HM12470HM12470 is a long-acting insulin analogue | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Number of participants with adverse events
Time frame: 1 month
An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products.
2 secondary outcomes
Cmax of HM12470
Time frame: 1 month
AUC of HM12470
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Type1 Diabetes Mellitus and Type2 Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
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 2 inclusion and 2 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 6 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 United States. 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?
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?
Number of participants with 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 6 Nov 2017.