Type 2 Diabetes MellitusPhase 2NCT00694057
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing HE3286 in people with Type 2 Diabetes Mellitus, run by Harbor Therapeutics at 22 sites in United States.
Trial summary
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HE3286
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 22 sitesUnited States
- Study dates
- Jun 2008to Jan 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patient with a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening.
- Patient with a fasting blood glucose level of ≤ 225 mg/dL at screening (≤ 255 mg/dl for drug-naive patients);
- Patient with HbA1c levels >7.5% (7.0 - 10.5% for drug-naive patients) at screening;
- Patient with BMI 28-37 kg/m2 for females 28-39 kg/m2 for males
Main Exclusion Criteria:
- Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
- Patient with unstable diabetic complications requiring treatment or ongoing active intervention;
- Patient with a history of long term insulin therapy within the past year;
- Patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
- Patient who has any clinically significant abnormalities in laboratory results at screening;
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Study site
Anaheim, California, 92801
Study site
Anaheim, California, 92805
Study site
Baton Rouge, Louisiana, 70808
Study site
Beverly Hills, California, 90211
Study site
Buena Park, California, 90620
Study site
Burbank, California, 91505
Study site
Carmichael, California, 95608
Study site
Chicago, Illinois, 60616
Study site
El Paso, Texas, 79905
Study site
Escondido, California, 92025
Study site
Fresno, California, 93726
Study site
Huntington Park, California, 90255
Study site
Kenosha, Wisconsin, 53142
Study site
Las Vegas, Nevada, 89106
Study site
Las Vegas, Nevada, 89148
Study site
Long Beach, California, 90806
Study site
Los Angeles, California, 90057
Study site
National City, California, 91950
Study site
Roseville, California, 95661
Study site
Salt Lake City, Utah, 84107
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63141
About this study
Official title: A Phase II, Double Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerance and Activity of HE3286 When Administered Orally for 12 Weeks to Adult Patients With Type 2 Diabetes Mellitus
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks.
Read the detailed description
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be the first in a new class of insulin sensitizers with a potentially novel mechanism of action that may improve the current therapeutic options available to a T2DM patient.
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks. Changes in hemoglobin A1c (HbA1c) will be assessed over a treatment period of 12-weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- HE3286, Placebo
- Keywords
- Type 2 Diabetes Mellitus, Metformin, HbA1c
- 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.
HE3286Drug
HE3286 10 mg per day (5 mg BID)
PlaceboDrug
Placebo capsules BID
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules BID Receives: Drug: Placebo |
| Active | Experimental | HE3286 10 mg (5 mg BID) Receives: Drug: HE3286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
Measured: 12-weeks
To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
Measured: 12-weeks
Secondary outcomes (2)
To evaluate the effect of HE3286 on fasting blood glucose over time.
Measured: 12-weeks
To evaluate the effect of HE3286 on insulin sensitivity over time.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 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
- NCT00694057
- Sponsor's protocol ID
- HE3286-0401
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2008
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerance and Activity of HE3286 When Administered Orally for 12 Weeks to Adult Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00694057
- Acronym / sponsor ID
- HE3286-0401
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Metformin, HbA1c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Harbor TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Jun 2008 (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.
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks.
Detailed description
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be the first in a new class of insulin sensitizers with a potentially novel mechanism of action that may improve the current therapeutic options available to a T2DM patient.
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks. Changes in hemoglobin A1c (HbA1c) will be assessed over a treatment period of 12-weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules BID |
| Active | Experimental | Drug: HE3286HE3286 10 mg (5 mg BID) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HE3286HE3286 10 mg per day (5 mg BID) | Drug | Active |
| PlaceboPlacebo capsules BID | Drug | Placebo |
Primary outcome
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
Time frame: 12-weeks
To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
Time frame: 12-weeks
2 secondary outcomes
To evaluate the effect of HE3286 on fasting blood glucose over time.
Time frame: 12-weeks
To evaluate the effect of HE3286 on insulin sensitivity over time.
Time frame: 12-weeks
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 14 Jun 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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HE3286 in people with Type 2 Diabetes Mellitus, run by Harbor Therapeutics at 22 sites 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?
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 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group. (time frame: 12-weeks). The study lists 2 primary outcomes in all. 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 14 Jun 2011.