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

June 4, 2019 updated by: Theracos

A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo capsules to match EGT0001474
Other Names:
  • Human SGLT2 inhibitor
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 Names:
  • Human SGLT2 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
25 days
AUC 0-t
Time Frame: 3 days
Area under the plasma concentration-time curve from time 0 to time t
3 days
AUC0-24
Time Frame: 3 days
Area under the plasma concentration-time curve from time 0 to hour 24
3 days
AUC Inf
Time Frame: 3 days
Area under the plasma concentration-time curve from time 0 to infinity
3 days
Cmax
Time Frame: 3 days
Maximum plasma concentration
3 days
Tmax
Time Frame: 3 days
Time of maximum plasma concentration
3 days
λz
Time Frame: 3 days
Terminal phase rate constant
3 days
t1/2
Time Frame: 3 days
Apparent terminal half life
3 days
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.
3 days
Vz/F
Time Frame: 3 days
Apparent volume of distribution
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theracos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-1474-C-396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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