Trial Outcomes & Findings for Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM) (NCT NCT01889667)

Results Overview

Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Eight (8) days

Results posted on

2015-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	ORMD-0801 Dose # 1 Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation	ORMD-0801 Dose # 2 Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation	Placebo Oil Capsules Placebo: Oil Capsules
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ORMD-0801 Dose # 1 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules	ORMD-0801 Dose # 2 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules	Placebo n=10 Participants Oil Capsules Placebo: Oil Capsules	Total n=30 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 4.9 • n=5 Participants	57.4 years STANDARD_DEVIATION 4.7 • n=7 Participants	53.6 years STANDARD_DEVIATION 12.0 • n=5 Participants	55.3 years STANDARD_DEVIATION 6.89 • n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: Eight (8) days

Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug

Outcome measures

Outcome measures
Measure	ORMD-0801 Dose # 1 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation	ORMD-0801 Dose # 2 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation	Placebo n=10 Participants Oil Capsules Placebo: Oil Capsules
Evaluate the Safety and Tolerability of ORMD-0801.	0 Number of Events	0 Number of Events	0 Number of Events

SECONDARY outcome

Timeframe: Seven (7) days, and last two days (Day 6 and day 7)

Population: Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations

Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801

Outcome measures

Outcome measures
Measure	ORMD-0801 Dose # 1 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation	ORMD-0801 Dose # 2 n=8 Participants Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation	Placebo n=10 Participants Oil Capsules Placebo: Oil Capsules
The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM) Last two days (day 6 and day 7)	135.64 mg/DL Standard Deviation 39.400	150.24 mg/DL Standard Deviation 49.264	167.95 mg/DL Standard Deviation 64.172
The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM) All Seven Days	139.73 mg/DL Standard Deviation 38.861	149.38 mg/DL Standard Deviation 38.249	165.85 mg/DL Standard Deviation 60.760

SECONDARY outcome

Timeframe: Seven (7) days, and last two days (Day 6 and day 7)

Population: Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations

Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801

Outcome measures

Outcome measures
Measure	ORMD-0801 Dose # 1 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation	ORMD-0801 Dose # 2 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation	Placebo n=10 Participants Oil Capsules Placebo: Oil Capsules
The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM) All Seven Days	152.55 mg/dL Standard Deviation 36.986	163.05 mg/dL Standard Deviation 30.282	175.99 mg/dL Standard Deviation 61.115
The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM) Last two days (day 6 and day 7)	153.23 mg/dL Standard Deviation 40.160	158.58 mg/dL Standard Deviation 40.672	176.06 mg/dL Standard Deviation 63.698

SECONDARY outcome

Timeframe: Screening, Day 2. Day 9

Population: Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring

Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801

Outcome measures

Outcome measures
Measure	ORMD-0801 Dose # 1 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation	ORMD-0801 Dose # 2 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation	Placebo n=10 Participants Oil Capsules Placebo: Oil Capsules
The Effect of ORMD-0801 on Morning Fasting Serum Insulin Screening	20.80 mg/dL Standard Deviation 18.984	17.34 mg/dL Standard Deviation 12.225	34.51 mg/dL Standard Deviation 64.375
The Effect of ORMD-0801 on Morning Fasting Serum Insulin Day 2	11.93 mg/dL Standard Deviation 10.122	12.94 mg/dL Standard Deviation 7.472	9.01 mg/dL Standard Deviation 4.665
The Effect of ORMD-0801 on Morning Fasting Serum Insulin Day 9	15.70 mg/dL Standard Deviation 8.559	15.51 mg/dL Standard Deviation 14.924	9.85 mg/dL Standard Deviation 3.977

SECONDARY outcome

Timeframe: Screening, Day 2, Day 9

Population: Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring

Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801

Outcome measures

Outcome measures
Measure	ORMD-0801 Dose # 1 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation	ORMD-0801 Dose # 2 n=10 Participants Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation	Placebo n=10 Participants Oil Capsules Placebo: Oil Capsules
The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo Screening	4.233 mg/dL Standard Deviation 2.3869	3.125 mg/dL Standard Deviation 1.3372	5.159 mg/dL Standard Deviation 4.9825
The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo Day 2	3.180 mg/dL Standard Deviation 1.6593	3.064 mg/dL Standard Deviation 0.9200	2.400 mg/dL Standard Deviation 0.9419
The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo Day 9	3.875 mg/dL Standard Deviation 1.6927	3.090 mg/dL Standard Deviation 1.1021	2.715 mg/dL Standard Deviation 0.8506

Adverse Events

ORMD-0801 Dose # 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ORMD-0801 Dose # 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ORMD-0801 Dose # 1 n=10 participants at risk Oral Insulin Formulation ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)	ORMD-0801 Dose # 2 n=10 participants at risk Oral Insulin Formulation ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)	Placebo n=10 participants at risk Oil Capsules Placebo: Oil Capsules
Gastrointestinal disorders number	30.0% 3/10 • Number of events 5	40.0% 4/10 • Number of events 5	50.0% 5/10 • Number of events 7

Additional Information

Chief Scientific Officer

Oramed

Phone: +972-2-566-0001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60