Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
164
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Jun 2008
Typical duration for phase_2 type-2-diabetes-mellitus
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 6, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 14, 2011
June 1, 2011
1.6 years
June 6, 2008
June 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
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.
12-weeks
Secondary Outcomes (2)
To evaluate the effect of HE3286 on fasting blood glucose over time.
12-weeks
To evaluate the effect of HE3286 on insulin sensitivity over time.
12-weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo capsules BID
Active
EXPERIMENTALHE3286 10 mg (5 mg BID)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Anaheim, California, 92805, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Buena Park, California, 90620, United States
Unknown Facility
Burbank, California, 91505, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Escondido, California, 92025, United States
Unknown Facility
Fresno, California, 93726, United States
Unknown Facility
Huntington Park, California, 90255, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Chicago, Illinois, 60616, United States
Unknown Facility
Baton Rouge, Louisiana, 70808, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Unknown Facility
Las Vegas, Nevada, 89148, United States
Unknown Facility
El Paso, Texas, 79905, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dwight R. Stickney, MD
Harbor Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 6, 2008
First Posted
June 10, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 14, 2011
Record last verified: 2011-06