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

NCT02969798 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-08-27

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Dapagliflozin

10mg/day

DRUG

Saxagliptin

5mg/day

DRUG

Pioglitazone

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

DRUG

Metformin

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

Sponsors & Collaborators

  • American Diabetes Association

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

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

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969798 on ClinicalTrials.gov