| Trial ID: | L3576 |
| Source ID: | NCT01889667
|
| Associated Drug: |
Ormd-0801 Dose # 1
|
| Title: |
Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01889667/results
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: ORMD-0801 Dose # 1|DRUG: ORMD-0801 Dose # 2|DRUG: Placebo
|
| Outcome Measures: |
Primary: Evaluate the Safety and Tolerability of ORMD-0801., Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug, Eight (8) days | Secondary: The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM), Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801, Seven (7) days, and last two days (Day 6 and day 7)|The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM), Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801, Seven (7) days, and last two days (Day 6 and day 7)|The Effect of ORMD-0801 on Morning Fasting Serum Insulin, Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801, Screening, Day 2. Day 9|The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo, Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801, Screening, Day 2, Day 9
|
| 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: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2013-11
|
| Results First Posted: |
2014-10-24
|
| Last Update Posted: |
2015-04-16
|
| Locations: |
Orange County Research Center, Tustin, California, 92780, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01889667
|
