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
13
Treatment groupsSee 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