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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT02969798
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2014
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Ralph A DeFronzo, MD
[email protected]
210-567-6691
Monica Palomo, BS
[email protected]
210-567-6710
Ralph A DeFronzo, MD (PRINCIPAL_INVESTIGATOR)
Eugenio Cersosimo, MD (SUB_INVESTIGATOR)

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By research site
The University of Texas Health Science Center at San Antonio· San Antonio, TX

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