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Study for Pre-diabetes with Impaired Fasting Glucose and Impaired Glucose Tolerance

This study is looking at different ways to treat pre-diabetes, specifically in people who have impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). Researchers want to see if certain medications can help improve how your body handles sugar (beta cell function, insulin sensitivity, and glucose tolerance). The medications being tested are dapagliflozin, saxagliptin, pioglitazone, and metformin. You might be able to join if you are between 18 and 65 years old and have IFG or IGT. The study will measure these improvements over 24 months to see which treatments are most effective. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 700 participants. It will compare the effects of four different medications.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after the treatment phase begins to measure beta cell function, insulin sensitivity, and glucose tolerance status.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02969798

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

Recruiting
NAAges 18–65InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~700 participants
Updated 2025-08-27 on ClinicalTrials.gov
What's tested:DapagliflozinSaxagliptinPioglitazoneMetformin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Beta cell function
Measured over 24 months after treatment phase begins
+2 more outcomes measured

Conditions

Diabetes Mellitus, Type 2
Impaired Glucose Tolerance (IGT)
Impaired Fasting Glucose (IFG)

Explore related trials

Glucose IntoleranceImpaired fasting glycemiaType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ralph A DeFronzo, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Ralph A DeFronzo, MD
[email protected]
210-567-6691
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Beta cell function24 months after treatment phase begins

    Beta cell function will be measured as insulin secretion during the hyperglycemic clamp (mean plasma insulin concentration in uU/ml) multiplied by insulin sensitivity measured with the euglycemic insulin clamp (mg/kg.min).

  • Insulin sensitivity24 months after treatment phase begins

    Insulin sensitivity will be measured with the euglycemic insulin clamp and expressed as mg/kg.min.

  • Glucose tolerance status24 months after treatment phase begins

    Glucose tolerance status will be evaluated by measuring the HbA1c which is a measure of the average of the amount of glucose attached to hemoglobin over the past 3 months, expressed as a percentage.