Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes - Full Text View

Sponsor:	Theracos
Information provided by:	Theracos
ClinicalTrials.gov Identifier:	NCT00924053

Purpose

The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: EGT0001474 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Theracos:

Primary Outcome Measures:

Assess safety and tolerability of EGT0001474 in patients with Type 2 diabetes [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess pharmacokinetics of EGT0001474 in patients with Type 2 diabetes [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Evaluate pharmacodynamic effects of EGT0001474 by determining urinary glucose excretion in patients with Type 2 diabetes [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	June 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EGT0001474: Experimental	Drug: EGT0001474 Cohort 1: single dose of 25 mg EGT0001474 given as an oral capsule; Cohort 2: single dose of 75 mg EGT0001474 given as 3 oral capsules; Cohort 3: single dose of 150 mg EGT0001474 given as 6 oral capsules.
Placebo: Placebo Comparator	Drug: Placebo Placebo capsules to match EGT0001474

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes.
Body mass Index (BMI) between 18 kg/m2 and 37 kg/m2.
HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive) while on diabetic medications.
If taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study.
Female subjects must be surgically sterilized or postmenopausal.
Non-smoker for at least 3 months.
Negative alcohol screen.

Exclusion Criteria:

Type 1 diabetes.
Use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea.
Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at screening.
Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
Previous treatment with EGT0001474.
Vaccination within 30 days prior to the first dose of study medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924053

Locations

United States, Texas
dgd Research Inc., a Cetero Research Company
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Theracos

Investigators

Study Chair:

Mason W. Freeman, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Theracos ( Edward P. Amento, M.D., President and CEO )
Study ID Numbers:	THR-1474-C-396
Study First Received:	June 16, 2009
Last Updated:	November 25, 2009
ClinicalTrials.gov Identifier:	NCT00924053 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theracos:

Diabetes Mellitus Type 2

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010