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Safety, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM

This study has been completed.
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
Oramed, Ltd.
ClinicalTrials.gov Identifier:
NCT01889667
First received: June 19, 2013
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: April 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Interventions: Drug: ORMD-0801 Dose # 1
Drug: ORMD-0801 Dose # 2
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    ORMD-0801 Dose # 1     ORMD-0801 Dose # 2     Placebo  
STARTED     10     10     10  
COMPLETED     10     10     10  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ORMD-0801 Dose # 1

Oral Insulin Formulation

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

ORMD-0801 Dose # 2

Oral Insulin Formulation

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

Placebo

Oil Capsules

Placebo: Oil Capsules

Total Total of all reporting groups

Baseline Measures
    ORMD-0801 Dose # 1     ORMD-0801 Dose # 2     Placebo     Total  
Number of Participants  
[units: participants]
  10     10     10     30  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 4.9     57.4  ± 4.7     53.6  ± 12.0     55.3  ± 6.89  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     10     10     30  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     5     3     7     15  
Male     5     7     3     15  
Region of Enrollment  
[units: participants]
       
United States     10     10     10     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Evaluate the Safety and Tolerability of ORMD-0801.   [ Time Frame: Eight (8) days ]

2.  Secondary:   The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)   [ Time Frame: Seven (7) days, and last two days (Day 6 and day 7) ]

3.  Secondary:   The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)   [ Time Frame: Seven (7) days, and last two days (Day 6 and day 7) ]

4.  Secondary:   The Effect of ORMD-0801 on Morning Fasting Serum Insulin   [ Time Frame: Screening, Day 2. Day 9 ]

5.  Secondary:   The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo   [ Time Frame: Screening, Day 2, Day 9 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: Oramed
phone: +972-2-566-0001
e-mail: aviva@oramed.com


No publications provided


Responsible Party: Oramed, Ltd.
ClinicalTrials.gov Identifier: NCT01889667     History of Changes
Other Study ID Numbers: ORA-D-009, ORMD-0801
Study First Received: June 19, 2013
Results First Received: April 28, 2014
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration