Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694057
• Other study ID #: HE3286-0401
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2008
• Last updated: June 11, 2011
• Start date: June 2008
• Est. completion date: January 2010

Study information

• Verified date: June 2011
• Source: Harbor Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HE3286
HE3286 10 mg per day (5 mg BID)
• Placebo
Placebo capsules BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harbor Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.		12-weeks	No
Primary	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	No
Secondary	To evaluate the effect of HE3286 on fasting blood glucose over time.		12-weeks	No
Secondary	To evaluate the effect of HE3286 on insulin sensitivity over time.		12-weeks	No