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Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus

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: NCT02496000
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : February 17, 2017
Last Update Posted : February 6, 2018
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 Type 2
Interventions Drug: ORMD-0801
Drug: Placebo Comparator
Enrollment 188
Recruitment Details  
Pre-assignment Details Study design: screening, followed by a 14 day wash-out followed by a 14-day single-blind run-in prior to the 28-day treatment period. Efficacy based on the Intend-to-treat population 80% trimming of the data. The safety (adverse events) data is based on the safety population.
Arm/Group Title Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1
Hide Arm/Group Description

three identical capsules containing placebo

Placebo Comparator: Placebo

three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo

ORMD-0801: Oral Insulin

three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1

ORMD-0801: Oral Insulin

Period Title: Overall Study
Started 64 61 63
Completed 62 56 61
Not Completed 2 5 2
Reason Not Completed
Withdrawal by Subject             1             2             0
Lost to Follow-up             1             0             1
Protocol Violation             0             0             1
Non-compliance or lack of cooperation             0             2             0
undetermined             0             1             0
Arm/Group Title Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1 Total
Hide Arm/Group Description

three identical capsules containing placebo

Placebo Comparator: Placebo

three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo

ORMD-0801: Oral Insulin

three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1

ORMD-0801: Oral Insulin

Total of all reporting groups
Overall Number of Baseline Participants 64 61 63 188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 61 participants 63 participants 188 participants
58.61  (9.203) 57.89  (8.021) 57.25  (8.786) 57.92  (8.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 63 participants 188 participants
Female
35
  54.7%
22
  36.1%
29
  46.0%
86
  45.7%
Male
29
  45.3%
39
  63.9%
34
  54.0%
102
  54.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 63 participants 188 participants
Hispanic or Latino
31
  48.4%
32
  52.5%
36
  57.1%
99
  52.7%
Not Hispanic or Latino
33
  51.6%
29
  47.5%
27
  42.9%
89
  47.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 63 participants 188 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   3.1%
2
   3.3%
2
   3.2%
6
   3.2%
Native Hawaiian or Other Pacific Islander
2
   3.1%
1
   1.6%
0
   0.0%
3
   1.6%
Black or African American
7
  10.9%
8
  13.1%
4
   6.3%
19
  10.1%
White
53
  82.8%
50
  82.0%
55
  87.3%
158
  84.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   3.2%
2
   1.1%
1.Primary Outcome
Title Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.
Hide Description The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.
Time Frame Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Intend-to-Treat Population, 80% trimming. The mean values will be analyzed using a one-way analysis of variance (ANOVA) model. The residuals from the ANOVA will be analyzed to verify that they are normally distributed. If not normally distributed, then a Kruskal-Wallis test (one-way analysis of variance on the ranks) will be performed.
Arm/Group Title Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1 ORMD-0801 Doses 1 and 2 Combined
Hide Arm/Group Description:

three identical capsules containing placebo

Placebo Comparator: Placebo

three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo

ORMD-0801: Oral Insulin

three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1

ORMD-0801: Oral Insulin

The combined measurements of dose 1 and dose 2, in units of mg/dL
Overall Number of Participants Analyzed 46 44 47 91
Mean (Standard Deviation)
Unit of Measure: mg/dL
13.70  (26.140) -3.67  (18.983) 6.64  (26.361) 1.66  (23.541)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Comparator, ORMD-0801 Dose 1, ORMD-0801 Dose 2 = 1.5 * Dose 1
Comments This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0117
Comments [Not Specified]
Method Kruskal-Wallis
Comments ANOVA model on the ranks
2.Secondary Outcome
Title The Effect of ORMD-0801 on Mean 24-hour Glucose
Hide Description The effect of ORMD-0801 (Dose 1 and Dose 2 individually and pooled) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups measured in mg/dL
Time Frame Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Difference of Mean (mg/dL) Fasting Glucose From Baseline to Week 4
Hide Description The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on absolute changes from baseline to Wk 4 in fasting morning blood glucose.
Time Frame Study day 1 (± 1 day) through Study day 29 (± 1 day)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Effect of ORMD-0801 on Mean Daytime Glucose
Hide Description The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on changes from baseline to Wk 4 of Continuous Glucose Monitoring (CGM) of mean daytime glucose, measured in mg/dL
Time Frame Study day 1 (±1 day) through Study day 29 (± 1 day)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title The Effect of ORMD-0801 on Changes in HbA1c
Hide Description The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on percent changes from baseline to Wk 4 in HbA1c
Time Frame Study day 1 (± 1 day) through Study day 29 (± 1 day)
Outcome Measure Data Not Reported
Time Frame eight (8) months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1
Hide Arm/Group Description

three identical capsules containing placebo

Placebo Comparator: Placebo

three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo

ORMD-0801: Oral Insulin

three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1

ORMD-0801: Oral Insulin

All-Cause Mortality
Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      1/61 (1.64%)      0/63 (0.00%)    
Nervous system disorders       
Serious Non-Treatment Emergent Adverse Event  [1]  0/64 (0.00%)  0 1/61 (1.64%)  1 0/63 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Basal Ganglia Stroke
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Comparator ORMD-0801 Dose 1 ORMD-0801 Dose 2 = 1.5 * Dose 1
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/61 (0.00%)      0/63 (0.00%)    
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
Name/Title: Joel M. Neutel, M. D.
Organization: Orange County Research Center
Phone: 714-541-5591
Responsible Party: Oramed, Ltd.
ClinicalTrials.gov Identifier: NCT02496000     History of Changes
Other Study ID Numbers: ORA-D-007
First Submitted: July 8, 2015
First Posted: July 14, 2015
Results First Submitted: October 31, 2016
Results First Posted: February 17, 2017
Last Update Posted: February 6, 2018