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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Nov 16, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how to better prevent type 2 diabetes in people who have early signs of trouble with blood sugar levels, specifically those with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). The researchers believe that IFG and IGT have different causes, so they want to test treatments that target these specific issues to help keep the pancreas (the part of the body that helps control blood sugar) functioning well and prevent full-blown diabetes.

To participate, you need to be between 18 and 65 years old and have specific blood sugar levels that show you are not yet diabetic but at risk. You should also have a stable weight and no major health problems. Participants will regularly visit the clinic for treatments and tests throughout the study. It's important to note that women who can become pregnant need to use birth control during the study. If you think you might qualify and are interested in helping with this important research, consider reaching out to learn more!

Gender

ALL

Eligibility 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.