Trial · NCT04150107
A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes
NCT04150107, Phase 2, Completed, Oramed, Ltd.; results first posted 2022-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes. Trials, record NCT04150107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04150107
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes
- NCT number
- NCT04150107
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Oramed, Ltd.
- Conditions
- Type 1 Diabetes
- Interventions
- ORMD-0801 Treatment A, ORMD-0801 Treatment B, Placebo
- First posted
- 2019-11-04
- Last updated
- 2022-06-02
- Results first posted
- 2022-06-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Combined Final ten days of each treatment period. Period1 (days -8 to 1)Period 2 (days 19 to 28) ,and Period 3 (days 47 to 56) | The least squares means difference of basal exogenous insulin between treatment A and placebo and treatment B and placebo, utilized over the final ten (10) days of each treatment period |
| Primary | Average Exogenous Bolus Insulin Compared to Baseline (Placebo) | Combined Final ten days of treatment per treatment period (Days -8 to 1, Days 19 to 28, and Days 47 to 56) | The amount of exogenous bolus insulin utilized over the final ten (10) days of each treatment period measured in mg/dL |
| Primary | Average Exogenous Total Insulin Compared to Baseline | Combined Final ten days of treatment , day -8 to 1 (Period 1) Days 19 to 28 (Period 2), Days 47 to 56 (Period 3) | The Least Squares Mean Difeerence ( (mg/dL) of total exogenous insulin (the sum of basal + bolus exogenous insulin) over the final ten (10) days of treatment. |
| Secondary | Daytime Average Mean Glucose Compared to Baseline | Combined Study days -8 to 1 (Period 1) Days 19 to 28 (Period 2), and days 47 to 56 (Period 3) | Least Squares Mean Difference from Baseline of Daytime Average Mean Glucose over the final ten (10) days of each treatment and each treatment period as measured by CGM. |
| Secondary | Daytime Glucose Coefficient of Variation Compared to Baseline | Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3) | Least Squares Mean Continuous Glucose Monitor (CGM) Glucose Coefficient of Variation measured over daytime hours, compared to Baseline |
| Secondary | Daytime Low Blood Glucose Index (LBGI) Compared to Baseline | Combined Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3) | Least Squares Mean Daytime Low Blood Glucose Index (LBGI) measured over the last ten (10) days of the treatment period, compared to Baseline LBGI is a clinical scale that indicates the probability for hypoglycemia. Blood Glucose Variability is an important measure because it provides additional clarification for HbA1c value. The risk of hypglycemic events and the LBGI scale is defined as follows: Minimal Risk ( LBGI \< 1.1) Low Risk ( 1.1 \< LBGI \< 2.5) Moderate Risk (2.5 \< LBGI \< 5), HIgh Risk ( LBGI \> 5) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Combined Final ten days of each treatment period. Period1 (days -8 to 1)Period 2 (days 19 to 28) ,and Period 3 (days 47 to 56) | Information collected at the day 28 visits (Day 28 and Day 56) will be analyzed using an Analysis of Covariance model with subject as a random effect. | mg/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Average Exogenous Bolus Insulin Compared to Baseline (Placebo) | Combined Final ten days of treatment per treatment period (Days -8 to 1, Days 19 to 28, and Days 47 to 56) | Safety Population | mg/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Average Exogenous Total Insulin Compared to Baseline | Combined Final ten days of treatment , day -8 to 1 (Period 1) Days 19 to 28 (Period 2), Days 47 to 56 (Period 3) | Safety Population The number of participants anylized is based on the the number of participants that completed at least 80% of the Continuous Glucose Montioring measurements. Participants that did not meet this criterion are not inclued in this analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Daytime Average Mean Glucose Compared to Baseline | Combined Study days -8 to 1 (Period 1) Days 19 to 28 (Period 2), and days 47 to 56 (Period 3) | Safety Population. The number of participants anylized is based on the the number of participants that completed at least 80% of the Continuous Glucose Montioring measurements. Participants that did not meet this criterion are not inclued in this analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Daytime Glucose Coefficient of Variation Compared to Baseline | Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3) | Safety Population. The number of participants anylized is based on the the number of participants that completed at least 80% of the Continuous Glucose Montioring measurements. Participants that did not meet this criterion are not inclued in this analysis. | percent (%) | LEAST_SQUARES_MEAN |
| SECONDARY | Daytime Low Blood Glucose Index (LBGI) Compared to Baseline | Combined Study Days -8 to 1 (Period 1), Days 19-28 (Period 2), and Days 47-56 (Period 3) | Safety Population. The number of participants anylized is based on the the number of participants that completed at least 80% of the Continuous Glucose Montioring measurements. Participants that did not meet this criterion are not inclued in this analysis | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Baseline | Least Squares Mean Baseline, Treatment A, Treatment B | 27.28 | Standard Error 2.489 | mg/dL |
| Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Treatment A | Least Squares Mean Baseline, Treatment A, Treatment B | 25.84 | Standard Error 2.486 | mg/dL |
| Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Treatment B | Least Squares Mean Baseline, Treatment A, Treatment B | 27.32 | Standard Error 2.492 | mg/dL |
| Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Baseline | Least Squares Mean Difference Treatment A minus Baseline or Treatment B minus Baseline | NA | Standard Error NA | mg/dL |
| Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Treatment A | Least Squares Mean Difference Treatment A minus Baseline or Treatment B minus Baseline | -1.43 | Standard Error 0.381 | mg/dL |
| Average Exogenous Basal Insulin Compared to Baseline (Placebo) | Treatment B | Least Squares Mean Difference Treatment A minus Baseline or Treatment B minus Baseline | 0.04 | Standard Error 0.421 | mg/dL |
| Average Exogenous Bolus Insulin Compared to Baseline (Placebo) | Baseline | Least Squares Means Baseline, Treatment A, Treatment B | 20.63 | Standard Error 2.033 | mg/dL |
| Average Exogenous Bolus Insulin Compared to Baseline (Placebo) | Treatment A | Least Squares Means Baseline, Treatment A, Treatment B | 20.77 | Standard Error 2.045 | mg/dL |
| Average Exogenous Bolus Insulin Compared to Baseline (Placebo) | Treatment B | Least Squares Means Baseline, Treatment A, Treatment B | 20.54 | Standard Error 2.049 | mg/dL |
| Average Exogenous Bolus Insulin Compared to Baseline (Placebo) | Baseline | Least Squares Means Difference Treatment A minus Baseline, Treatmen B minus Baseline | NA | Standard Error NA | mg/dL |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1- Placebo run-in (All Patients) | STARTED | Placebo Followed by Treatment A Followed by Treatment B | 14 | |
| Period 1- Placebo run-in (All Patients) | STARTED | Placebo Followed by Treatment B Followed by Treatment A | 16 | |
| Period 1- Placebo run-in (All Patients) | COMPLETED | Placebo Followed by Treatment A Followed by Treatment B | 14 | |
| Period 1- Placebo run-in (All Patients) | COMPLETED | Placebo Followed by Treatment B Followed by Treatment A | 16 | |
| Period 1- Placebo run-in (All Patients) | NOT COMPLETED | Placebo Followed by Treatment A Followed by Treatment B | 0 | |
| Period 1- Placebo run-in (All Patients) | NOT COMPLETED | Placebo Followed by Treatment B Followed by Treatment A | 0 | |
| Period 2- Either Treatment A or B | STARTED | Placebo Followed by Treatment A Followed by Treatment B | 14 | |
| Period 2- Either Treatment A or B | STARTED | Placebo Followed by Treatment B Followed by Treatment A | 16 | |
| Period 2- Either Treatment A or B | COMPLETED | Placebo Followed by Treatment A Followed by Treatment B | 14 | |
| Period 2- Either Treatment A or B | COMPLETED | Placebo Followed by Treatment B Followed by Treatment A | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharangitis | Infections and infestations | Placebo | 0 | 30 | 0 |
| other | Nasopharangitis | Infections and infestations | Treatment A ORMD-0801 | 0 | 30 | 0 |
| other | Nasopharangitis | Infections and infestations | Treatment B ORMD-0801 | 1 | 30 | 1 |
| other | OTITIS EXTERNA | Infections and infestations | Placebo | 0 | 30 | 0 |
| other | OTITIS EXTERNA | Infections and infestations | Treatment A ORMD-0801 | 0 | 30 | 0 |
| other | OTITIS EXTERNA | Infections and infestations | Treatment B ORMD-0801 | 1 | 30 | 1 |
| other | Sinusitis | Immune system disorders | Placebo | 0 | 30 | 0 |
| other | Sinusitis | Immune system disorders | Treatment A ORMD-0801 | 0 | 30 | 0 |
| other | Sinusitis | Immune system disorders | Treatment B ORMD-0801 | 1 | 30 | 1 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 0 | 30 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 30 |
| Total, all-cause mortality | Treatment A ORMD-0801 | 0 | 30 |
| Total, all-cause mortality | Treatment B ORMD-0801 | 0 | 30 |
| Total, other adverse events | Placebo | 0 | 30 |
| Total, other adverse events | Treatment A ORMD-0801 | 9 | 30 |
| Total, other adverse events | Treatment B ORMD-0801 | 6 | 30 |
| Total, serious adverse events | Placebo | 0 | 30 |
| Total, serious adverse events | Treatment A ORMD-0801 | 0 | 30 |
| Total, serious adverse events | Treatment B ORMD-0801 | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04150107
GET https://conductscience.org/api/trials/v1/NCT04150107/results?page=2