Type 2 DiabetesPhase 2NCT02081118
Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
A Phase 2 study testing HM11260C 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 month 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2015
- 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
- Taking a stable dose of 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 at screening
- 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 acute or 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, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a month 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, 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.
HM11260CDrug
Also called LAPS-Exendin-4
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
PlaceboDrug
Placebo for HM11260C
| Study group | Role | What they receive |
|---|---|---|
| HM11260C (8 mg) | Experimental | Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks Receives: Drug: HM11260C |
| HM11260C (12 mg) | Experimental | Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks Receives: Drug: HM11260C |
| HM11260C (16 mg) | Experimental | Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks Receives: Drug: HM11260C |
| Placebo | Placebo comparator | Monthly administration of placebo by subcutaneous injection for 16 weeks Receives: Drug: Placebo |
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 16 weeks
Measured: Up to day 155
Secondary outcomes (8)
Fasting plasma glucose levels (FPG)
Measured: Up to day 155
7-point glucose profile
Measured: Up to day 155
Serum lipid profile
Measured: Up to day 155
Body weight
Measured: Up to day 155
Fasting insulin
Measured: Up to day 155
C-peptide
Measured: Up to day 155
Glucagon
Measured: Up to day 155
Glycated albumin
Measured: Up to day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 209 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
- NCT02081118
- Sponsor's protocol ID
- HM-EXC-204
- Status last verified
- Aug 2016
- First submitted
- 24 Feb 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin
- ClinicalTrials.gov ID
- NCT02081118
- Acronym / sponsor ID
- HM-EXC-204
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Mar 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 month 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
- 4
| Arm | Type | Receives |
|---|---|---|
| HM11260C (8 mg) | Experimental | Drug: HM11260CMonthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks |
| HM11260C (12 mg) | Experimental | Drug: HM11260CMonthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks |
| HM11260C (16 mg) | Experimental | Drug: HM11260CMonthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMonthly administration of placebo by subcutaneous injection for 16 weeks |
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
- Taking a stable dose of 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 at screening
- 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 (12 mg), HM11260C (16 mg), HM11260C (8 mg) |
| PlaceboPlacebo for HM11260C | Drug | Placebo |
Primary outcome
Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks
Time frame: Up to day 155
8 secondary outcomes
Fasting plasma glucose levels (FPG)
Time frame: Up to day 155
7-point glucose profile
Time frame: Up to day 155
Serum lipid profile
Time frame: Up to day 155
Body weight
Time frame: Up to day 155
Fasting insulin
Time frame: Up to day 155
C-peptide
Time frame: Up to day 155
Glucagon
Time frame: Up to day 155
Glycated albumin
Time frame: Up to day 155
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.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 2 study testing HM11260C 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 16 weeks (time frame: Up to day 155). 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 9 Aug 2016.