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Clinical Trial Details

Trial ID: L5618
Source ID: NCT02535715
Associated Drug: Ormd-0801 Capsules- 2x8mg
Title: A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02535715/results
Conditions: Type 1 Diabetes
Interventions: DRUG: ORMD-0801 capsules- 2x8mg|DRUG: ORMD-0801 capsules- 3x8mg|DRUG: ORMD-0801 capsules- 1x16mg
Outcome Measures: Primary: Hepatic Glucose Production (Co-primary Outcome), Tritiated glucose infusion during procedures (Baseline and every 30 minutes during procedures) Calculated from plasma(mg/kg-minute). Averaged every 30 minutes., Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month | Secondary: Plasma Insulin Concentrations, Baseline and every 15 minutes during procedures (microIU/mL)., Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month|Plasma Glucose Concentrations, Measured at baseline and every 5 minutes during the procedures(mg/dL), Averaged over 30 minute intervals during the procedure, Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month|Plasma Glucagon Concentrations, Measured at baseline and every 30 minutes during the procedures (pg/mL), Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month|Plasma Free Fatty Acid Concentrations, Measured at baseline and every 30 minutes during the procedures (micro mol/L), Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month
Sponsor/Collaborators: Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: Oramed, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 11
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2017-04
Results First Posted: 2019-03-21
Last Update Posted: 2019-03-21
Locations: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT02535715