Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6725
Source ID: NCT04150107
Associated Drug: Ormd-0801 Treatment A
Title: A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04150107/results
Conditions: Type 1 Diabetes
Interventions: DRUG: ORMD-0801 Treatment A|DRUG: ORMD-0801 Treatment B|OTHER: Placebo
Outcome Measures: Primary: Average Exogenous Basal Insulin Compared to Baseline (Placebo), The least squares means difference of basal exogenous insulin between treatment A and placebo and treatment B and placebo, utilized over the final ten (10) days of each treatment period, Combined Final ten days of each treatment period. Period1 (days -8 to 1)Period 2 (days 19 to 28) ,and Period 3 (days 47 to 56)|Average Exogenous Bolus Insulin Compared to Baseline (Placebo), The amount of exogenous bolus insulin utilized over the final ten (10) days of each treatment period measured in mg/dL, Combined Final ten days of treatment per treatment period (Days -8 to 1, Days 19 to 28, and Days 47 to 56)|Average Exogenous Total Insulin Compared to Baseline, The Least Squares Mean Difeerence ( (mg/dL) of total exogenous insulin (the sum of basal + bolus exogenous insulin) over the final ten (10) days of treatment., Combined Final ten days of treatment , day -8 to 1 (Period 1) Days 19 to 28 (Period 2), Days 47 to 56 (Period 3) | Secondary: Daytime Average Mean Glucose Compared to Baseline, Least Squares Mean Difference from Baseline of Daytime Average Mean Glucose over the final ten (10) days of each treatment and each treatment period as measured by CGM., Combined Study days -8 to 1 (Period 1) Days 19 to 28 (Period 2), and days 47 to 56 (Period 3)|Daytime Glucose Coefficient of Variation Compared to Baseline, Least Squares Mean Continuous Glucose Monitor (CGM) Glucose Coefficient of Variation measured over daytime hours, compared to Baseline, Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3)|Daytime Low Blood Glucose Index (LBGI) Compared to Baseline, Least Squares Mean Daytime Low Blood Glucose Index (LBGI) measured over the last ten (10) days of the treatment period, compared to Baseline LBGI is a clinical scale that indicates the probability for hypoglycemia. Blood Glucose Variability is an important measure because it provides additional clarification for HbA1c value. The risk of hypglycemic events and the LBGI scale is defined as follows: Minimal Risk ( LBGI \< 1.1) Low Risk ( 1.1 \< LBGI \< 2.5) Moderate Risk (2.5 \< LBGI \< 5), HIgh Risk ( LBGI \> 5), Combined Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3)
Sponsor/Collaborators: Sponsor: Oramed, Ltd. | Collaborators: Integrium
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-17
Completion Date: 2020-03-12
Results First Posted: 2022-06-02
Last Update Posted: 2022-06-02
Locations: Orange County Research Center, Tustin, California, 92780, United States
URL: https://clinicaltrials.gov/show/NCT04150107