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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889667
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : October 24, 2014
Last Update Posted : April 16, 2015
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
Oramed, Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus Type 2
Interventions Drug: ORMD-0801 Dose # 1
Drug: ORMD-0801 Dose # 2
Drug: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation

Oil Capsules

Placebo: Oil Capsules

Period Title: Overall Study
Started 10 10 10
Completed 10 10 10
Not Completed 0 0 0
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo Total
Hide Arm/Group Description

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules

Oil Capsules

Placebo: Oil Capsules

Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 30 participants
54.1  (4.9) 57.4  (4.7) 53.6  (12.0) 55.3  (6.89)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
5
  50.0%
3
  30.0%
7
  70.0%
15
  50.0%
Male
5
  50.0%
7
  70.0%
3
  30.0%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 30 participants
10 10 10 30
1.Primary Outcome
Title Evaluate the Safety and Tolerability of ORMD-0801.
Hide Description Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug
Time Frame Eight (8) days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description:

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation

Oil Capsules

Placebo: Oil Capsules

Overall Number of Participants Analyzed 10 10 10
Measure Type: Number
Unit of Measure: Number of Events
0 0 0
2.Secondary Outcome
Title The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)
Hide Description Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801
Time Frame Seven (7) days, and last two days (Day 6 and day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description:

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules

Oil Capsules

Placebo: Oil Capsules

Overall Number of Participants Analyzed 10 8 10
Mean (Standard Deviation)
Unit of Measure: mg/DL
Last two days (day 6 and day 7) 135.64  (39.400) 150.24  (49.264) 167.95  (64.172)
All Seven Days 139.73  (38.861) 149.38  (38.249) 165.85  (60.760)
3.Secondary Outcome
Title The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)
Hide Description Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801
Time Frame Seven (7) days, and last two days (Day 6 and day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description:

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules

Oil Capsules

Placebo: Oil Capsules

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
All Seven Days 152.55  (36.986) 163.05  (30.282) 175.99  (61.115)
Last two days (day 6 and day 7) 153.23  (40.160) 158.58  (40.672) 176.06  (63.698)
4.Secondary Outcome
Title The Effect of ORMD-0801 on Morning Fasting Serum Insulin
Hide Description Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801
Time Frame Screening, Day 2. Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description:

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules

Oil Capsules

Placebo: Oil Capsules

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
Screening 20.80  (18.984) 17.34  (12.225) 34.51  (64.375)
Day 2 11.93  (10.122) 12.94  (7.472) 9.01  (4.665)
Day 9 15.70  (8.559) 15.51  (14.924) 9.85  (3.977)
5.Secondary Outcome
Title The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo
Hide Description Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801
Time Frame Screening, Day 2, Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description:

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules

Oil Capsules

Placebo: Oil Capsules

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
Screening 4.233  (2.3869) 3.125  (1.3372) 5.159  (4.9825)
Day 2 3.180  (1.6593) 3.064  (0.9200) 2.400  (0.9419)
Day 9 3.875  (1.6927) 3.090  (1.1021) 2.715  (0.8506)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Hide Arm/Group Description

Oral Insulin Formulation

ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)

Oral Insulin Formulation

ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)

Oil Capsules

Placebo: Oil Capsules

All-Cause Mortality
ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ORMD-0801 Dose # 1 ORMD-0801 Dose # 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      4/10 (40.00%)      5/10 (50.00%)    
Gastrointestinal disorders       
number   3/10 (30.00%)  5 4/10 (40.00%)  5 5/10 (50.00%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: Oramed
Phone: +972-2-566-0001
EMail: aviva@oramed.com
Layout table for additonal information
Responsible Party: Oramed, Ltd.
ClinicalTrials.gov Identifier: NCT01889667    
Other Study ID Numbers: ORA-D-009
ORMD-0801 ( Other Identifier: Oramed, Ltd. )
First Submitted: June 19, 2013
First Posted: June 28, 2013
Results First Submitted: April 28, 2014
Results First Posted: October 24, 2014
Last Update Posted: April 16, 2015