Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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;

⁃ Stable body weight (±4lbs) over the preceding 3 months

⁃ Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data

⁃ Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):

• Oral contraceptive

∙ Injectable progesterone

∙ Subdermal implant

∙ Spermicidal foam/gel/film/cream/suppository

∙ Diaphragm with spermicide

∙ Copper or hormonal containing IUD

∙ Sterile male partner vasectomized \> 6 month pre-dosing.

⁃ Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

⁃ Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

Locations
United States
Texas
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Ralph A DeFronzo, MD
defronzo@uthscsa.edu
210-567-6691
Backup
Monica Palomo, BS
palomom@uthscsa.edu
210-567-6710
Time Frame
Start Date: 2014-01-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 700
Treatments
No_intervention: Healthy normal glucose tolerance (NGT) subjects
Subjects (Fasting Plasma Glucose or FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl) without FH (family history) of diabetes in a first degree relative
Active_comparator: Isolated IGT with Dapagliflozin
Healthy subjects with isolated IGT (FPG \< 100; 2-h PG = 140-199) will receive dapagliflozin, 10 mg/day
Active_comparator: Isolated IGT with Saxagliptin
Healthy subjects with isolated IGT (FPG \< 100; 2-h PG = 140-199) will receive saxagliptin, 5 mg/day
Active_comparator: Isolated IGT with Pioglitazone
Healthy subjects with isolated IGT (FPG \< 100; 2-h PG = 140-199) will receive pioglitazone, the dose will increase from 15 mg/day to 30 mg/day at month two
Active_comparator: Isolated IGT with Metformin
Healthy subjects with isolated IGT (FPG \< 100; 2-h PG = 140-199) will receive Metformin, starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Active_comparator: Isolated IFG with Dapagliflozin
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG \< 140) will receive dapagloflozin, 10mg/day
Active_comparator: Isolated IFG with Saxagliptin
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG \< 140) will receive saxagliptin, 10mg/day
Active_comparator: Isolated IFG with Pioglitazone
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG \< 140) will receive pioglitazone, the dose will increase from 15 mg/day to 30 mg/day at month two
Active_comparator: Isolated IFG with Metformin
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG \< 140) will receive Metformin, starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Active_comparator: IGT plus IFG with Dapagliflozin
Healthy subjects with IGT plus IFG will receive dapagliflozin, 10mg/day
Active_comparator: IGT plus IFG with Saxagliptin
Healthy subjects with IGT plus IFG will receive saxagliptin, 10mg/day
Active_comparator: IGT plus IFG with Pioglitazone
Healthy subjects with IGT plus IFG will receive pioglitazone, the dose will increase from 15 mg/day to 30 mg/day at month two
Active_comparator: IGT plus IFG with Metformin
Healthy subjects with IGT plus IFG will receive Metformin, starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association, AstraZeneca
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov