Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HE3286
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Metformin, HbA1c
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Active
Arm Description
Placebo capsules BID
HE3286 10 mg (5 mg BID)
Outcomes
Primary Outcome Measures
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
Secondary Outcome Measures
To evaluate the effect of HE3286 on fasting blood glucose over time.
To evaluate the effect of HE3286 on insulin sensitivity over time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00694057
Brief Title
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harbor Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Metformin, HbA1c
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules BID
Arm Title
Active
Arm Type
Experimental
Arm Description
HE3286 10 mg (5 mg BID)
Intervention Type
Drug
Intervention Name(s)
HE3286
Intervention Description
HE3286 10 mg per day (5 mg BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules BID
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the effect of HE3286 on fasting blood glucose over time.
Time Frame
12-weeks
Title
To evaluate the effect of HE3286 on insulin sensitivity over time.
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight R. Stickney, MD
Organizational Affiliation
Harbor Therapeutics
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
City
Long Beach,
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
We'll reach out to this number within 24 hrs