Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Theracos
ClinicalTrials.gov Identifier:
NCT00924053
First received: June 16, 2009
Last updated: July 21, 2011
Last verified: July 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Theracos:

Primary Outcome Measures:
  • Safety and Tolerability of EGT0001474 [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]
    Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.

  • AUC 0-t [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Area under the plasma concentration-time curve from time 0 to time t

  • AUC0-24 [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Area under the plasma concentration-time curve from time 0 to hour 24

  • AUC Inf [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Area under the plasma concentration-time curve from time 0 to infinity

  • Cmax [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Maximum plasma concentration

  • Tmax [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Time of maximum plasma concentration

  • λz [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Terminal phase rate constant

  • t1/2 [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Apparent terminal half life

  • CL/F [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.

  • Vz/F [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Apparent volume of distribution


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
Experimental: EGT0001474 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.
Other Name: Human SGLT2 inhibitor
Placebo Comparator: Placebo Drug: Placebo
Placebo capsules to match EGT0001474
Other Name: Human SGLT2 inhibitor

Detailed Description:

EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. This would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as Type 2 diabetes).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

Responsible Party: Albert R. Collinson., President and CEO, Theracos
ClinicalTrials.gov Identifier: NCT00924053     History of Changes
Other Study ID Numbers: THR-1474-C-396
Study First Received: June 16, 2009
Results First Received: October 25, 2010
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Theracos:
Diabetes Mellitus Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014