Trial Outcomes & Findings for A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus (NCT NCT02954601)
NCT ID: NCT02954601
Last Updated: 2018-07-12
Results Overview
Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Day 3 (run-in) and Day 8 (Day 5 of Active treatment)
Results posted on
2018-07-12
Participant Flow
Following the screening, eligible subjects entered a 3-day, single-blind placebo run-in. On Day 4, each subject was randomized to a treatment sequence for each of three treatment periods, each period was either placebo or 1 of the 3 treatments). All subjects received placebo and only 2 of the 3 treatments.
The number of participants receiving each intervention, in each Period, is reported. In each treatment period, each subject received randomly either placebo, qd, bid, or tid for each of 3 treatment periods. Subjects received the randomized treatment from Day 4 through Day 8. There was a 24-hour single-blind placebo washout on Day 9.
Participant milestones
| Measure |
Placebo
Placebo (fish oil) Placebo: fish oil placebo
|
Dose1
Dose 1 = ORMD-0801 qid
|
Dose2
Dose 2 = ORMD-0801 bid
|
Dose 3
Dose 3 = ORMD-0801 tid
|
|---|---|---|---|---|
|
First Intervention (Five Days)
STARTED
|
11
|
6
|
8
|
7
|
|
First Intervention (Five Days)
COMPLETED
|
11
|
6
|
7
|
7
|
|
First Intervention (Five Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Second Intervention (Five Days)
STARTED
|
11
|
6
|
8
|
6
|
|
Second Intervention (Five Days)
COMPLETED
|
11
|
6
|
8
|
6
|
|
Second Intervention (Five Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention (Five Days)
STARTED
|
9
|
8
|
6
|
8
|
|
Third Intervention (Five Days)
COMPLETED
|
9
|
8
|
6
|
8
|
|
Third Intervention (Five Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (fish oil) Placebo: fish oil placebo
|
Dose1
Dose 1 = ORMD-0801 qid
|
Dose2
Dose 2 = ORMD-0801 bid
|
Dose 3
Dose 3 = ORMD-0801 tid
|
|---|---|---|---|---|
|
First Intervention (Five Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Placebo (fish oil)
|
ORMD-0801 qd
n=6 Participants
Oral Insulin once per day
|
ORMD-0801 Bid
n=7 Participants
Oral Insulin twice per day
|
ORMD-0801 Tid
n=7 Participants
Oral Insulin three times per day
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.27 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
57.17 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 7.03 • n=5 Participants
|
58.71 years
STANDARD_DEVIATION 7.54 • n=4 Participants
|
57.72 years
STANDARD_DEVIATION 7.77 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Child-Bearing Status
Not Applicable (Male)
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Child-Bearing Status
Of Childbearing Potential
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Child-Bearing Status
Post Hysterectomy
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Child-Bearing Status
Surgically Sterilized
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Child-Bearing Status
At least 1 year Post-Menopausal
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Alcohol History
Never
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Alcohol History
Current
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Alcohol History
Former
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Tobacco History
Never
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Tobacco History
Current
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Tobacco History
Former
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Caffiene History
Never
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Caffiene History
Current
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Caffiene History
Former
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 3 (run-in) and Day 8 (Day 5 of Active treatment)Population: Intend to Treat Population
Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment)
Outcome measures
| Measure |
Placebo
n=31 Participants
Fish Oil placebo
|
Dose 1
n=20 Participants
ORMD-0801 qid
|
Dose 2
n=20 Participants
ORMD-0801 bid
|
Dose 3
n=21 Participants
ORMD-0801 tid
|
|---|---|---|---|---|
|
Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM)
|
-4.94 mg/dL
Standard Deviation 4.418
|
-10.00 mg/dL
Standard Deviation 7.236
|
-1.21 mg/dL
Standard Deviation 7.397
|
-11.42 mg/dL
Standard Deviation 8.451
|
SECONDARY outcome
Timeframe: Day 3 and Day 8Population: Intend to Treat (ITT)
For each dose, calculate the ratio of the C-Peptide measurement area-under-the-curve (ng-hr/mL) Day 8 to the C-peptide measurement area-under-the-curve (ng-hr/mL) Day 3. This ratio is called the C-peptide Ratio.
Outcome measures
| Measure |
Placebo
n=31 Participants
Fish Oil placebo
|
Dose 1
n=20 Participants
ORMD-0801 qid
|
Dose 2
n=21 Participants
ORMD-0801 bid
|
Dose 3
n=21 Participants
ORMD-0801 tid
|
|---|---|---|---|---|
|
Calculate the C-peptide Ratio for Single and Multiple Doses of ORMD-0801 vs Placebo.
|
0.97 ratio
Standard Error 0.034
|
1.01 ratio
Standard Error 0.056
|
1.03 ratio
Standard Error 0.047
|
0.93 ratio
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Day 3 through Day 8 of treatmentPopulation: Safety population
The number of safety parameter hypoglycemic events for single and multiple doses of ORMD-0801 vs placebo.
Outcome measures
| Measure |
Placebo
n=31 Participants
Fish Oil placebo
|
Dose 1
n=20 Participants
ORMD-0801 qid
|
Dose 2
n=21 Participants
ORMD-0801 bid
|
Dose 3
n=21 Participants
ORMD-0801 tid
|
|---|---|---|---|---|
|
The Number Hypoglycemic Events for Single and Multiple Doses of ORMD-0801 vs Placebo
|
3 number of hypoglycemic events
|
2 number of hypoglycemic events
|
4 number of hypoglycemic events
|
5 number of hypoglycemic events
|
SECONDARY outcome
Timeframe: Day 3 and Day 8 (two timepoints)Population: Intend to Treat mean values reported for Doses 1, 2, and 3 are placebo-adjusted doses (Active dose mean minus placebo dose mean)
Calculate the difference between pre-treatment (Day 3) and end of treatment (Day 8) mean daytime CGM glucose for single and multiple doses of ORMD-0801 vs placebo.
Outcome measures
| Measure |
Placebo
n=31 Participants
Fish Oil placebo
|
Dose 1
n=20 Participants
ORMD-0801 qid
|
Dose 2
n=21 Participants
ORMD-0801 bid
|
Dose 3
n=20 Participants
ORMD-0801 tid
|
|---|---|---|---|---|
|
Calculate the Difference Between Values of Pre-treatment and End-of-treatment Mean Daytime CGM Glucose
|
-4.11 mg/dL
Standard Error 5.080
|
-13.96 mg/dL
Standard Error 7.775
|
1.13 mg/dL
Standard Error 7.772
|
-16.78 mg/dL
Standard Error 8.613
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Dose 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose 2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=31 participants at risk
Placebo (fish oil) Placebo: fish oil placebo
|
Dose 1
n=20 participants at risk
Dose 1 = ORMD-0801 qid
|
Dose 2
n=21 participants at risk
Dose 2 = ORMD-0801 bid
|
Dose 3
n=20 participants at risk
Dose 3 = ORMD-0801 tid
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.5%
2/31 • Number of events 2 • One Year
|
5.0%
1/20 • Number of events 1 • One Year
|
19.0%
4/21 • Number of events 4 • One Year
|
5.0%
1/20 • Number of events 1 • One Year
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
9.7%
3/31 • Number of events 3 • One Year
|
5.0%
1/20 • Number of events 1 • One Year
|
9.5%
2/21 • Number of events 2 • One Year
|
0.00%
0/20 • One Year
|
|
Eye disorders
Eye Disorders
|
0.00%
0/31 • One Year
|
0.00%
0/20 • One Year
|
0.00%
0/21 • One Year
|
5.0%
1/20 • Number of events 1 • One Year
|
|
Metabolism and nutrition disorders
Metabolism and Nutrional Disorders
|
22.6%
7/31 • Number of events 7 • One Year
|
25.0%
5/20 • Number of events 5 • One Year
|
28.6%
6/21 • Number of events 6 • One Year
|
10.0%
2/20 • Number of events 2 • One Year
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective tissue disorders
|
3.2%
1/31 • Number of events 1 • One Year
|
5.0%
1/20 • Number of events 1 • One Year
|
0.00%
0/21 • One Year
|
0.00%
0/20 • One Year
|
|
Nervous system disorders
Nervous System Disorders
|
3.2%
1/31 • Number of events 1 • One Year
|
0.00%
0/20 • One Year
|
9.5%
2/21 • Number of events 2 • One Year
|
0.00%
0/20 • One Year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/31 • One Year
|
0.00%
0/20 • One Year
|
4.8%
1/21 • Number of events 1 • One Year
|
0.00%
0/20 • One Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place