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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02969798
• Date of registration: 16/03/2016
• Prospective Registration: No
• Primary sponsor: The University of Texas Health Science Center at San Antonio
• Public title: Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
• Scientific title: Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
• Date of first enrolment: January 1, 2014
• Target sample size: 700
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02969798
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ralph A DeFronzo, MD

• Name: Ralph A DeFronzo, MD
• Affiliation: The University of Texas Health Science Center at San Antonio

• Name: Ralph A DeFronzo, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

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

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

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

3. BMI = 24-40 kg/m2;

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

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

6. 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.

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

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

Exclusion Criteria:

1. 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.

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

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

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

5. Subjects participating in an excessively heavy exercise program

6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time
sleeping schedule

7. Subjects taking medications known to alter glucose metabolism (with the exception of
metformin and/or pioglitazone) or which effect brain neurosynaptic function are
excluded.

8. Subjects with evidence of major organ system disease as determined by physical exam,
history, and screening laboratory data

9. Pregnant subjects or subjects unwilling to use birth control during their study
enrollment

10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening.

11. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study

12. Subjects with hematuria will be excluded.

13. Subjects with evidence or prior history of heart failure will be excluded

14. Subjects with family history of pancreatic, bladder, and breast cancer will be
excluded.

15. Subjects with history of pancreatitis will be excluded.

16. Subjects with eGFR < 60 ±5 ml/min.1.73m2 will be excluded.

17. Subjects with elevated serum creatinine (>1.5 mg/dl males/1.4 mg/dl females) will be
excluded.

18. Subjects with a history of orthostatic hypotension (>15/10 mmHg) will be excluded.

19. Subjects with liver enzymes (ALT, AST) >3-fold above upper normal limit will be
excluded.

20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or
Saxagliptin will be excluded.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Impaired Glucose Tolerance (IGT)

Impaired Fasting Glucose (IFG)

Intervention(s)

Drug: Saxagliptin

Drug: Dapagliflozin

Drug: Metformin

Drug: Pioglitazone

Primary Outcome(s)

Insulin sensitivity [Time Frame: 24 months after treatment phase begins]

Glucose tolerance status [Time Frame: 24 months after treatment phase begins]

Beta cell function [Time Frame: 24 months after treatment phase begins]

Secondary ID(s)

HSC20130414H

R01DK024092-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Diabetes Association

AstraZeneca

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