Trial Outcomes & Findings for A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics (NCT NCT02094534)
NCT ID: NCT02094534
Last Updated: 2017-07-06
Results Overview
Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)
Results posted on
2017-07-06
Participant Flow
All subjects took all doses of intervention.
Basal Exogenous Insulin - Intend to Treat (ITT) - All Subjects
Participant milestones
| Measure |
ORMD-0801
API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
|
Placebo
Fish oil in capsules, identical in appearance to ORMD-0801
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
10
|
|
Overall Study
COMPLETED
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
Baseline characteristics by cohort
| Measure |
ORMD-0801
n=15 Participants
API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
|
Placebo
n=10 Participants
Fish oil in capsules, identical in appearance to ORMD-0801
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.90 years
STANDARD_DEVIATION 11.936 • n=5 Participants
|
37.61 years
STANDARD_DEVIATION 9.642 • n=7 Participants
|
38.255 years
STANDARD_DEVIATION 15.343 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)Population: Intend-to-treat polpulation
Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.
Outcome measures
| Measure |
ORMD-0801
n=15 Participants
API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
|
Placebo
n=10 Participants
Fish oil in capsules, identical in appearance to ORMD-0801
|
|---|---|---|
|
Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements
Total Exogenous Insulin Usage
|
-2.09 mg/dL
Standard Deviation 10.936
|
2.83 mg/dL
Standard Deviation 12.716
|
|
Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements
Basal Exogenous Insulin Usage
|
-1.92 mg/dL
Standard Deviation 7.517
|
-1.10 mg/dL
Standard Deviation 10.423
|
|
Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements
Bolus Exogenous Insulin Usage
|
-0.18 mg/dL
Standard Deviation 10.310
|
3.93 mg/dL
Standard Deviation 6.541
|
SECONDARY outcome
Timeframe: last two days (day 6 and day 7, averaged)Population: Intent to treat (ITT) population; This measurement is reported for those subjects who had at least 80% of the CGM readings. This explains why there are two fewer subjects from the ITT population reported for this endpoint.
Mean glucose levels (by continuous glucose monitoring (CGM)) in Type 1 diabetes patients treated with ORMD-0801, compared to the mean glucose levels (by continuous glucose monitoring) for patients treated with placebo.
Outcome measures
| Measure |
ORMD-0801
n=14 Participants
API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
|
Placebo
n=9 Participants
Fish oil in capsules, identical in appearance to ORMD-0801
|
|---|---|---|
|
Mean Nighttime, Daytime, and Fasting Glucose Levels
Mean fasting glucose levels by CGM
|
122.15 mg/dL
Standard Deviation 32.670
|
138.69 mg/dL
Standard Deviation 35.295
|
|
Mean Nighttime, Daytime, and Fasting Glucose Levels
Mean nighttime levels by CGM
|
137.65 mg/dL
Standard Deviation 31.311
|
133.17 mg/dL
Standard Deviation 23.321
|
|
Mean Nighttime, Daytime, and Fasting Glucose Levels
Mean daytime glucose levels by CGM
|
145.15 mg/dL
Standard Deviation 18.408
|
165.73 mg/dL
Standard Deviation 19.372
|
Adverse Events
ORMD-0801
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ORMD-0801
n=15 participants at risk
API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
|
Placebo
n=10 participants at risk
Fish oil in capsules, identical in appearance to ORMD-0801
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
100.0%
15/15 • Number of events 201 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
100.0%
10/10 • Number of events 124 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
86.7%
13/15 • Number of events 51 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
90.0%
9/10 • Number of events 41 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
0.00%
0/10 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
10.0%
1/10 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
0.00%
0/10 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
0.00%
0/10 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
10.0%
1/10 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
10.0%
1/10 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
0.00%
0/10 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Nervous system disorders
Head discomfort
|
6.7%
1/15 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
0.00%
0/10 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
10.0%
1/10 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
0.00%
0/10 • Three Months
Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
|
Additional Information
Joel M. Neutel, M.D., Study Director
Orange County Research Center
Phone: 714-550-9990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement is "work for hire"
- Publication restrictions are in place
Restriction type: OTHER