Clinical trial NCT00694057: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Metformin
HbA1c
Lead sponsor: Harbor Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
timeFrame: 12-weeks
measure: To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
timeFrame: 12-weeks
Secondary outcomes:
measure: To evaluate the effect of HE3286 on fasting blood glucose over time.
timeFrame: 12-weeks
measure: To evaluate the effect of HE3286 on insulin sensitivity over time.
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Burbank
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Escondido
country: United States
state: California
city: Fresno
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Long Beach,
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: National City
country: United States
state: California
city: Roseville
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Kenosha
country: United States
state: Wisconsin
Study officials:
affiliation: Harbor Therapeutics
name: Dwight R. Stickney, MD
role: STUDY_DIRECTOR
References: