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Clinical Trial Details

Trial ID: L4546
Source ID: NCT03704818
Associated Drug: Dapagliflozin 5mg
Title: Dapagliflozin Effects on Hypoglycemia
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type1 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin 5mg|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: Glucagon Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which glucagon will be measured. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing glucagon., 12 Weeks|Epinephrine Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which epinephrine will be measured. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing epinephrine., 12 Weeks|Norepinephrine Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which norepinephrine will be measured. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing norepinephrine., 12 Weeks|Cortisol Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which cortisol will be measured. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing cortisol., 12 Weeks|Growth Hormone Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which growth hormone will be measured. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing growth hormone., 12 Weeks|Hypoglycemia Awareness, Participants will undergo a baseline hypoglycemic clamp during which they will complete the Edinburgh Hypoglycemia Scale (EHS). Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing the EHS., 12 Weeks|Trails Making B Performance Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which they will complete the cognitive test, Trails Making B. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing Trails Making B., 12 Weeks|Digit Symbol Substitution Performance Response to Hypoglycemia, Participants will undergo a baseline hypoglycemic clamp during which they will complete the cognitive test, Digit Symbol Substitution. Follow-up hypoglycemic clamps will be performed after each 4-week treatment period re-assessing Digit Symbol Substitution., 12 Weeks |
Sponsor/Collaborators: Sponsor: University of California, San Diego | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-10-08
Completion Date: 2021-11-30
Results First Posted:
Last Update Posted: 2024-01-23
Locations: UC San Diego Altman Clinical & Translational Research Institute, La Jolla, California, 92037, United States
URL: https://clinicaltrials.gov/show/NCT03704818