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NCT Number: NCT00924053

Safety, Tolerability and Pharmacokinetics Study 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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

dgd Research Inc., a Cetero Research Company

San Antonio, Texas, 78229, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EGT0001474

Drug

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

Placebo

Drug

Placebo capsules to match EGT0001474

Other names: Human SGLT2 inhibitor

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Theracos

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 18, 2009
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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