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

ConditionsDiabetes Mellitus, Type 2Impaired Glucose Tolerance (IGT)Impaired Fasting Glucose (IFG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center at San Antonio

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    10mg/day

  • Saxagliptin

    Drug

    5mg/day

  • Pioglitazone

    Drug

    the dose will increase from 15 mg/day to 30 mg/day at month two

  • Metformin

    Drug

    starting at 1000 mg/day and increased to 2000 mg/day at month 2.

Treatment groups

700 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: Healthy normal glucose tolerance (NGT) subjectsNo intervention 0 interventions
Group B: Isolated IGT with DapagliflozinActive comparator 1 intervention
Group C: Isolated IGT with SaxagliptinActive comparator 1 intervention
Group D: Isolated IGT with PioglitazoneActive comparator 1 intervention
Group E: Isolated IGT with MetforminActive comparator 1 intervention
Group F: Isolated IFG with DapagliflozinActive comparator 1 intervention
Group G: Isolated IFG with SaxagliptinActive comparator 1 intervention
Group H: Isolated IFG with PioglitazoneActive comparator 1 intervention
Group I: Isolated IFG with MetforminActive comparator 1 intervention
Group J: IGT plus IFG with DapagliflozinActive comparator 1 intervention
Group K: IGT plus IFG with SaxagliptinActive comparator 1 intervention
Group L: IGT plus IFG with PioglitazoneActive comparator 1 intervention
Group M: IGT plus IFG with MetforminActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Beta cell function

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).

Time frame
24 months after treatment phase begins
2

Insulin sensitivity

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

Time frame
24 months after treatment phase begins
3

Glucose tolerance status

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.

Time frame
24 months after treatment phase begins

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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