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Trial record 3 of 4 for:    18308683 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924053
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : August 17, 2011
Last Update Posted : June 17, 2019
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: EGT0001474 Drug: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

  2. AUC 0-t [ Time Frame: 3 days ]
    Area under the plasma concentration-time curve from time 0 to time t

  3. AUC0-24 [ Time Frame: 3 days ]
    Area under the plasma concentration-time curve from time 0 to hour 24

  4. AUC Inf [ Time Frame: 3 days ]
    Area under the plasma concentration-time curve from time 0 to infinity

  5. Cmax [ Time Frame: 3 days ]
    Maximum plasma concentration

  6. Tmax [ Time Frame: 3 days ]
    Time of maximum plasma concentration

  7. λz [ Time Frame: 3 days ]
    Terminal phase rate constant

  8. t1/2 [ Time Frame: 3 days ]
    Apparent terminal half life

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

  10. Vz/F [ Time Frame: 3 days ]
    Apparent volume of distribution

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924053

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United States, Texas
dgd Research Inc., a Cetero Research Company
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Study Chair: Mason W. Freeman, M.D. Massachusetts General Hospital


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Responsible Party: Theracos Identifier: NCT00924053     History of Changes
Other Study ID Numbers: THR-1474-C-396
First Posted: June 18, 2009    Key Record Dates
Results First Posted: August 17, 2011
Last Update Posted: June 17, 2019
Last Verified: June 2019
Keywords provided by Theracos:
Diabetes Mellitus Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs