Insulin ResistancePhase 1NCT00991107
A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
A Phase 1 study testing HE3286 in people with Insulin Resistance, run by Harbor Therapeutics at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- HE3286
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subject 18-65 years of age
- Body Mass Index (BMI) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males
- Subject has fasting blood glucose level of < 126 mg/dL at Screening
- Subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dL at Screening
- Subject has fasting plasma insulin >=10 μU/mL
Who cannot join
- Subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition;
- Subject has any clinically significant abnormalities in laboratory results at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production When Administered Orally to Obese Insulin-Resistant Adult Subjects for 28 Days
The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Read the detailed description
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a synthetic analog of a naturally occurring hormone with a potentially new mechanism of action that may improve the current therapeutic options available to a T2DM patient.
The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the observed activity of HE3286 in reducing insulin resistance in both impaired glucose intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further understand the mechanism of action and to design future clinical trials.
- Conditions
- Insulin Resistance
- Being tested
- HE3286
- Keywords
- phase I, safety, tolerance, insulin resistance, obese
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HE3286Drug
Also called TRIOLEX
HE3286 20 mg (10 mg BID) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| HE3286 | Experimental | HE3286 20 mg (10 mg BID) Receives: Drug: HE3286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects
Measured: Study duration and 1-month follow-up
Secondary outcomes (1)
Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Measured: Study period (28-days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbor Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dwight R. Stickney, MD, Study director, Harbor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991107
- Sponsor's protocol ID
- HE3286-0103
- Status last verified
- Mar 2011
- First submitted
- 5 Oct 2009
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production When Administered Orally to Obese Insulin-Resistant Adult Subjects for 28 Days
- ClinicalTrials.gov ID
- NCT00991107
- Acronym / sponsor ID
- HE3286-0103
- Conditions
- Insulin Resistance
- Keywords
- phase I, safety, tolerance, insulin resistance, obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Harbor TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Oct 2009 (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 objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Detailed description
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a synthetic analog of a naturally occurring hormone with a potentially new mechanism of action that may improve the current therapeutic options available to a T2DM patient.
The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the observed activity of HE3286 in reducing insulin resistance in both impaired glucose intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further understand the mechanism of action and to design future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HE3286 | Experimental | Drug: HE3286HE3286 20 mg (10 mg BID) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subject 18-65 years of age
- Body Mass Index (BMI) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males
- Subject has fasting blood glucose level of < 126 mg/dL at Screening
- Subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dL at Screening
- Subject has fasting plasma insulin >=10 μU/mL
Key exclusion criteria (2 listed)
- Subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition;
- Subject has any clinically significant abnormalities in laboratory results at screening
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 |
|---|---|---|
| HE3286Also: TRIOLEXHE3286 20 mg (10 mg BID) for 28 days | Drug | HE3286 |
Primary outcome
Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects
Time frame: Study duration and 1-month follow-up
1 secondary outcome
Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Time frame: Study period (28-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 Mar 2011.
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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.
Dwight R. Stickney, MD study director
Harbor Therapeutics
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 HE3286 in people with Insulin Resistance, run by Harbor Therapeutics 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 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: finished, as of the sponsor's last update on 9 Mar 2011. 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?
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?
Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects (time frame: Study duration and 1-month follow-up). 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 Mar 2011.