| Trial ID: | L3621 |
| Source ID: | NCT03168295
|
| Associated Drug: |
Dapagliflozin 10mg Then Placebo Oral Tablet
|
| Title: |
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03168295/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin 10mg then Placebo Oral Tablet|DRUG: Placebo Oral Tablet then Dapagliflozin 10mg
|
| Outcome Measures: |
Primary: Change in Endogenous Glucose Production (EGP), Renal transplant subjects with native kidneys intact underwent measurement of EGP with an 8 hour infusion of 3-3H-glucose on 2 separate days with the administration in random order of either dapagliflozin 10mg or placebo after 3 hours of the tracer equilibration period. The equilibration at 3 hours was considered the baseline measurement. Measurement of change in endogenous glucose production was obtained for all subjects., baseline and 240-300 minutes | Secondary: Change in Fasting Plasma Glucose, Change in Fasting Plasma Glucose in Type 2 Diabetes Mellitus subjects only, baseline and 240-300 minutes|Change in Fasting Plasma Insulin, Change in Fasting Plasma Insulin in Type 2 Diabetes Mellitus subjects in diabetic subjects only, baseline and 240-300 minutes
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
34
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2016-10
|
| Completion Date: |
2019-05-15
|
| Results First Posted: |
2020-01-14
|
| Last Update Posted: |
2020-09-17
|
| Locations: |
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03168295
|
