Type 2 DiabetesPhase 2NCT02057172
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
A Phase 2 study testing HM11260C and liraglutide in people with Type 2 Diabetes, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HM11260C and liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 2
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages eligible for study : 18 years to 74 years
- Genders eligible for study : Male and Female
- Diagnosed with T2DM
- Received diet and exercise therapy with or without metformin monotherapy
- HbA1c levels of between ≥ 7.0% and ≤ 10.0%
- Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
- Written informed consent must be obtained
Who cannot join
- Pregnant or nursing (lactating) women
- Diagnosis of type 1 diabetes mellitus
- Uncontrolled diabetes defined as a FPG level of > 240 mg/dL
- A significant change in body weight in the 3 months before screening
- Any history of GI intolerance
- Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
- Known history of chronic pancreatitis
- A history of alcohol or drug abuse or drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).
- Conditions
- Type 2 Diabetes
- Being tested
- HM11260C, liraglutide, Placebo
- Keywords
- glycaemic control, HM11260C, placebo, safety, tolerability, type 2 diabetes mellitus, efficacy, T2DM, glycated haemoglobin (HbA1c), glycosylated haemoglobin (HbA1c), Glucagon-Like Peptide-1 (GLP-1) agonists, blood sugar levels, fasting plasma glucose (FPG)
- 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.
HM11260CDrug
Also called LAPS-Exendin-4
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
liraglutideDrug
Also called Victoza
Liraglutide is a GLP-1 agonist.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HM11260C (0.3 mg) | Experimental | Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks Receives: Drug: HM11260C |
| HM11260C (1 mg) | Experimental | Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks Receives: Drug: HM11260C |
| HM11260C (2 mg) | Experimental | Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks Receives: Drug: HM11260C |
| HM11260C (3 mg) | Experimental | Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks Receives: Drug: HM11260C |
| HM11260C (4 mg) | Experimental | Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks Receives: Drug: HM11260C |
| Placebo | Placebo comparator | Weekly administration of placebo by subcutaneous injection for 12 weeks Receives: Drug: Placebo |
| Liraglutide | Active comparator | Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg. Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks
Measured: Up to 127 days
Secondary outcomes (6)
Fasting plasma glucose levels (FPG)
Measured: Up to 127 days
7-point glucose profile
Measured: Up to day 127
Other glycaemic control parameters
Measured: Up to day 127
Serum lipid profile
Measured: Up to day 127
Body weight
Measured: Up to day 127
Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%
Measured: Up to 127 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionDec 2014
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 Type 2 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmi Pharmaceutical, Study director, clinical4@hanmi.co.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057172
- Sponsor's protocol ID
- HM-EXC-203
- Status last verified
- Aug 2016
- First submitted
- 30 Jan 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH. Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide. Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18.
PubMed 31320446
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02057172
- Acronym / sponsor ID
- HM-EXC-203
- Conditions
- Type 2 Diabetes
- Keywords
- glycaemic control, HM11260C, placebo, safety, tolerability, type 2 diabetes mellitus, efficacy, T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 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.
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| HM11260C (0.3 mg) | Experimental | Drug: HM11260CWeekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks |
| HM11260C (1 mg) | Experimental | Drug: HM11260CWeekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks |
| HM11260C (2 mg) | Experimental | Drug: HM11260CWeekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks |
| HM11260C (3 mg) | Experimental | Drug: HM11260CWeekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks |
| HM11260C (4 mg) | Experimental | Drug: HM11260CWeekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboWeekly administration of placebo by subcutaneous injection for 12 weeks |
| Liraglutide | Active comparator | Drug: liraglutideLiraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages eligible for study : 18 years to 74 years
- Genders eligible for study : Male and Female
- Diagnosed with T2DM
- Received diet and exercise therapy with or without metformin monotherapy
- HbA1c levels of between ≥ 7.0% and ≤ 10.0%
Key exclusion criteria (8 listed)
- Pregnant or nursing (lactating) women
- Diagnosis of type 1 diabetes mellitus
- Uncontrolled diabetes defined as a FPG level of > 240 mg/dL
- A significant change in body weight in the 3 months before screening
- Any history of GI intolerance
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-4HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue) | Drug | HM11260C (0.3 mg), HM11260C (1 mg), HM11260C (2 mg), HM11260C (3 mg), HM11260C (4 mg) |
| liraglutideAlso: VictozaLiraglutide is a GLP-1 agonist. | Drug | Liraglutide |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks
Time frame: Up to 127 days
6 secondary outcomes
Fasting plasma glucose levels (FPG)
Time frame: Up to 127 days
7-point glucose profile
Time frame: Up to day 127
Other glycaemic control parameters
Time frame: Up to day 127
Serum lipid profile
Time frame: Up to day 127
Body weight
Time frame: Up to day 127
Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%
Time frame: Up to 127 days
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 9 Aug 2016.
- Derived from this study: PubMed 31320446Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH. Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide. Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18.
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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 Pharmaceutical study director
clinical4@hanmi.co.kr
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 HM11260C and liraglutide in people with Type 2 Diabetes, 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 7 inclusion and 8 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 9 Aug 2016. 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. 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?
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 in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks (time frame: Up to 127 days). 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 NCT02057172, 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 9 Aug 2016.