Diabetes MellitusPhase 1NCT02059564
A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
A Phase 1 study testing HM11260C and Victoza in people with Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus 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?
- HM11260C and Victoza
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2014
- 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
- Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
- History of type 2 diabetes
- Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
- Use of approved methods of contraception
- Ability to provide written informed consent
Who cannot join
- Type 1 diabetes
- Significant acute diabetic proliferative retinopathy or severe neuropathy
- Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to randomization
- History of any major surgery within 6 months prior to Screening
Show all 13Show fewer
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- History of renal disease or significantly abnormal kidney function tests at Screening
- History of hepatic disease or significantly abnormal liver function tests
- History of any active infection within 30 days prior to Randomization
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
- Donation or loss of >500 mL of blood or blood product within 56 days of Randomization
Trial locations and contacts
1 site in 1 country.
Hanmi Clinical contact
United States1 site, 1 recruiting
- Recruiting
Hanmi
California City, California
Hanmi Clinical, clinical4@hanmi.co.kr
Hanmi Clinical
About this study
Official title: A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
Read the detailed description
Primary Objective
- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying
Secondary Objectives
- evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test
- evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide
- evaluate safety and tolerability of different doses of HM11260C and liraglutide
- evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C
- Conditions
- Diabetes Mellitus
- Being tested
- HM11260C, Placebo, Victoza
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Exendin-4
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM11260CDrug
Also called LAPS-Exendin-4
doses of 6 mg, 16 mg
PlaceboDrug
Also called Normal saline solution
Normal saline solution
VictozaDrug
Also called Liraglutide
doses of 1.8 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | The weekly treatment of the 6 mg HM11260C or placebo will be maintained Receives: Drug: HM11260C; Drug: Placebo |
| Cohort B | Experimental | The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg Receives: Drug: HM11260C; Drug: Placebo |
| Cohort C | Experimental | The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg Receives: Drug: Victoza |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of acetaminophen
Cmax, AUC at 13 weeks
Measured: 13 weeks
Secondary outcomes (2)
Glucose metabolism
Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks
Measured: 13 weeks
Safety and tolerability
Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmi Clinical, Principal investigator, California, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059564
- Sponsor's protocol ID
- HM-EXC-102
- Status last verified
- Feb 2014
- First submitted
- 5 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hompesch M, Kang J, Han O, Trautmann ME, Sorli CH, Ogbaa I, Stewart J, Morrow L. Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002208. doi: 10.1136/bmjdrc-2021-002208.
PubMed 34172436
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02059564
- Acronym / sponsor ID
- HM-EXC-102
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Exendin-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Feb 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.
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
Detailed description
Primary Objective
- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying
Secondary Objectives
- evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test
- evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide
- evaluate safety and tolerability of different doses of HM11260C and liraglutide
- evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: HM11260C, Drug: PlaceboThe weekly treatment of the 6 mg HM11260C or placebo will be maintained |
| Cohort B | Experimental | Drug: HM11260C, Drug: PlaceboThe monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg |
| Cohort C | Experimental | Drug: VictozaThe daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
- History of type 2 diabetes
- Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
- Use of approved methods of contraception
- Ability to provide written informed consent
Key exclusion criteria (13 listed)
- Type 1 diabetes
- Significant acute diabetic proliferative retinopathy or severe neuropathy
- Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to randomization
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 |
|---|---|---|
| HM11260CAlso: LAPS-Exendin-4doses of 6 mg, 16 mg | Drug | Cohort A, Cohort B |
| PlaceboAlso: Normal saline solutionNormal saline solution | Drug | Cohort A, Cohort B |
| VictozaAlso: Liraglutidedoses of 1.8 mg | Drug | Cohort C |
Primary outcome
PK profile of acetaminophen
Time frame: 13 weeks
Cmax, AUC at 13 weeks
2 secondary outcomes
Glucose metabolism
Time frame: 13 weeks
Safety and tolerability
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Derived from this study: PubMed 34172436Hompesch M, Kang J, Han O, Trautmann ME, Sorli CH, Ogbaa I, Stewart J, Morrow L. Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002208. doi: 10.1136/bmjdrc-2021-002208.
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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 Clinical contact
Hanmi Clinical principal investigator
California, United States
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 HM11260C and Victoza in people with 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 5 inclusion and 13 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 11 Feb 2014. 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?
Contact Hanmi Clinical (clinical4@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK profile of acetaminophen (time frame: 13 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 NCT02059564, 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 11 Feb 2014.