Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
NCT ID: NCT02969798
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
700 participants
INTERVENTIONAL
2014-01-01
2027-07-31
Brief Summary
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Detailed Description
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1. To examine the effect of the following pharmacologic interventions on beta cell function, insulin sensitivity, and glucose tolerance status in individuals with isolated impaired glucose tolerance (IGT): (i) treatment with the renal Sodium-glucose co-transporter 2 (SGLT2) inhibitor inhibitor, dapagliflozin; (ii) treatment with the inhibitors of dipeptidyl peptidase 4, also DPP4, saxagliptin ; (iii) treatment with the thiazolidinedione, pioglitazone; (iv) treatment with the biguanide, metformin.
2. To examine the effect of the following pharmacologic interventions on beta cell function, insulin sensitivity, and glucose tolerance status in individuals with isolated impaired fasting glucose (IFG): (i) treatment with the renal SGLT2 inhibitor, dapagliflozin; (ii) treatment with the DPP4 inhibitor, saxagliptin; (iii) treatment with the thiazolidinedione, pioglitazone; (iv) treatment with the biguanide, metformin.
3. To examine the effect of the following pharmacologic interventions on beta cell function, insulin sensitivity, and glucose tolerance status in individuals with combined impaired glucose tolerance (IGT) plus impaired fasting glucose (IFG): i) treatment with the renal SGLT2 inhibitor, dapagliflozin; (ii) treatment with the DPP4 inhibitor, saxagliptin; (iii) treatment with the thiazolidinedione, pioglitazone; (iv) treatment with the biguanide, metformin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
No interventions assigned to this group
Isolated IGT with Dapagliflozin
Healthy subjects with isolated IGT (FPG \< 100; 2-h PG = 140-199) will receive dapagliflozin, 10 mg/day
Dapagliflozin
10mg/day
Isolated IGT with Saxagliptin
Healthy subjects with isolated IGT (FPG \< 100; 2-h PG = 140-199) will receive saxagliptin, 5 mg/day
Saxagliptin
5mg/day
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
Pioglitazone
the dose will increase from 15 mg/day to 30 mg/day at month two
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.
Metformin
starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Isolated IFG with Dapagliflozin
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG \< 140) will receive dapagloflozin, 10mg/day
Dapagliflozin
10mg/day
Isolated IFG with Saxagliptin
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG \< 140) will receive saxagliptin, 10mg/day
Saxagliptin
5mg/day
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
Pioglitazone
the dose will increase from 15 mg/day to 30 mg/day at month two
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.
Metformin
starting at 1000 mg/day and increased to 2000 mg/day at month 2.
IGT plus IFG with Dapagliflozin
Healthy subjects with IGT plus IFG will receive dapagliflozin, 10mg/day
Dapagliflozin
10mg/day
IGT plus IFG with Saxagliptin
Healthy subjects with IGT plus IFG will receive saxagliptin, 10mg/day
Saxagliptin
5mg/day
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
Pioglitazone
the dose will increase from 15 mg/day to 30 mg/day at month two
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.
Metformin
starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Interventions
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Dapagliflozin
10mg/day
Saxagliptin
5mg/day
Pioglitazone
the dose will increase from 15 mg/day to 30 mg/day at month two
Metformin
starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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American Diabetes Association
OTHER
AstraZeneca
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Ralph A DeFronzo, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC20130414H
Identifier Type: -
Identifier Source: org_study_id
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