Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.

Eligibility criteria

Qualifiers

NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects

Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening.

FPG < 100 mg/dl and 2-h PG < 140 mg/dl

BMI = 24-40 kg/m2;

Disqualifiers

Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.

Subjects with a family history of diabetes in a first degree relative

BMI of less than 24 or greater than 40 kg/m2

Unstable body weight (change of greater than ±4lbs over the preceding 3 months

Trial design

Treatments tested in this trial

  • Dapagliflozin
  • Saxagliptin
  • Pioglitazone
  • Metformin

Treatment groups

700 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Sponsors and collaborators

The University of Texas Health Science Center at San Antonio

Lead sponsor

American Diabetes Association

Collaborator

AstraZeneca

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator