| Trial ID: | L7076 |
| Source ID: | NCT02969798
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Impaired Glucose Tolerance (IGT)|Impaired Fasting Glucose (IFG)
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Saxagliptin|DRUG: Pioglitazone|DRUG: Metformin
|
| Outcome Measures: |
Primary: 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)., 24 months after treatment phase begins|Insulin sensitivity, Insulin sensitivity will be measured with the euglycemic insulin clamp and expressed as mg/kg.min., 24 months after treatment phase begins|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., 24 months after treatment phase begins |
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: American Diabetes Association|AstraZeneca|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
700
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-01-01
|
| Completion Date: |
2027-07
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-07
|
| Locations: |
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02969798
|
