Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00694057
Last Updated: 2011-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2008-06-30
2010-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo capsules BID
Placebo
Placebo capsules BID
Active
HE3286 10 mg (5 mg BID)
HE3286
HE3286 10 mg per day (5 mg BID)
Interventions
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HE3286
HE3286 10 mg per day (5 mg BID)
Placebo
Placebo capsules BID
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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;
18 Years
65 Years
ALL
No
Sponsors
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Harbor Therapeutics
INDUSTRY
Responsible Party
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Hollis-Eden Pharmaceuticals
Principal Investigators
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Dwight R. Stickney, MD
Role: STUDY_DIRECTOR
Harbor Therapeutics
Locations
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Anaheim, California, United States
Anaheim, California, United States
Beverly Hills, California, United States
Buena Park, California, United States
Burbank, California, United States
Carmichael, California, United States
Escondido, California, United States
Fresno, California, United States
Huntington Park, California, United States
Long Beach, California, United States
Los Angeles, California, United States
National City, California, United States
Roseville, California, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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HE3286-0401
Identifier Type: -
Identifier Source: org_study_id
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