Status:
COMPLETED
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Harbor Therapeutics
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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 o...
Eligibility Criteria
Inclusion
- Main
- 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
- 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;
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00694057
Start Date
June 1 2008
End Date
January 1 2010
Last Update
June 14 2011
Active Locations (22)
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1
Anaheim, California, United States, 92801
2
Anaheim, California, United States, 92805
3
Beverly Hills, California, United States, 90211
4
Buena Park, California, United States, 90620