Trial · NCT03467932
A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus
NCT03467932, Phase 2, Completed, Oramed, Ltd.; results first posted 2022-11-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus. Trials, record NCT03467932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03467932
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus
- NCT number
- NCT03467932
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 373 participants, actual
- Lead sponsor
- Oramed, Ltd.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Interventions
- Cohort A: ORMD-0801, Placebo oral capsule, Cohort B: ORMD-0801
- First posted
- 2018-03-16
- Last updated
- 2022-11-08
- Results first posted
- 2022-11-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of HbA1C (Glycated Hemoglobin) | baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up) | Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C. |
| Secondary | Mean Change From Baseline Over Time for HbA1C | Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks. | Mean change from baseline (Run-In, Week 0 Visit 1) to Part 1, Visit 3 for HbA1C (measured in mmols/mol) |
| Secondary | Change Over Time in Hb1Ac | Baseline (week 0, visit 1) to Week 10, part 2 | Change of Hb1Ac from Baseline to Week 10, measured in mmol/mol |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of HbA1C (Glycated Hemoglobin) | baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up) | Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis. | percent HbA1C | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over Time for HbA1C | Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks. | Intend-to-Treat; data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis. | mmol/mol | LEAST_SQUARES_MEAN |
| SECONDARY | Change Over Time in Hb1Ac | Baseline (week 0, visit 1) to Week 10, part 2 | Intent-to-Treat; data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis. | mmol/mol | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Combined Cohort A +Cohort B: Matched-Placebo Oral Capsule | -0.13 | 95% Confidence Interval -0.86 to 0.59 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort A: ORMD-0801 Once Daily - QHS | -0.60 | 95% Confidence Interval -1.37 to 0.16 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort A: ORMD-0801 Twice Daily - BID | -0.59 | 95% Confidence Interval -1.32 to 0.14 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort A: ORMD-0801 Three Times Daily - TID | -0.51 | 95% Confidence Interval -1.27 to 0.25 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort B:ORMD-0801, 8 mg Once Daily - QHS: | -0.95 | 95% Confidence Interval -1.87 to -0.03 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort B: ORMD-0801 8 mg Twice Daily - BID | -0.95 | 95% Confidence Interval -1.84 to -0.07 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort B: ORMD-0801 16 mg Once Daily - QHS: | 0.12 | 95% Confidence Interval -0.80 to 1.04 | percent HbA1C | |
| Change From Baseline of HbA1C (Glycated Hemoglobin) | Cohort B: ORMD-0801 16 mg Twice Daily - BID | -0.50 | 95% Confidence Interval -1.47 to 0.48 | percent HbA1C | |
| Mean Change From Baseline Over Time for HbA1C | Combined Cohort A+Cohort B: Matched-Placebo Oral Capsule | -2.12 | 95% Confidence Interval -4.40 to 0.16 | mmol/mol | |
| Mean Change From Baseline Over Time for HbA1C | Cohort A: ORMD-0801 Once Daily - QHS | -2.56 | 95% Confidence Interval -4.94 to -0.19 | mmol/mol |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: ORMD-0801 Once Daily - QHS | 69 | |
| Overall Study | STARTED | Cohort A: ORMD-0801 Twice Daily - BID | 68 | |
| Overall Study | STARTED | Cohort A: ORMD-0801 Three Times Daily - TID | 69 | |
| Overall Study | STARTED | Cohort A: Matched Placebo Oral Capsule | 66 | |
| Overall Study | STARTED | Cohort A (Sub-Cohort A): Excipient-Matched Placebo Three Times Daily-TID | 20 | |
| Overall Study | STARTED | Cohort B:ORMD-0801, 8 mg Once Daily - QHS: | 15 | |
| Overall Study | STARTED | Cohort B: ORMD-0801 8 mg Twice Daily - BID | 17 | |
| Overall Study | STARTED | Cohort B: ORMD-0801 16 mg Once Daily - QHS: | 18 | |
| Overall Study | STARTED | Cohort B: ORMD-0801 16 mg Twice Daily - BID | 15 | |
| Overall Study | STARTED | Cohort B - Matched Placebo Oral Capsule | 16 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events495
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 | Anemia | Blood and lymphatic system disorders | Combined Cohort A + Cohort B: Matched Placebo | 0 | 82 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort A: ORMD-0801 Once Daily - QD | 3 | 69 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Cohort A: ORMD-0801 Twice Daily - BID | 1 | 68 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort A: ORMD-0801 Three Times Daily - TID | 0 | 69 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B:ORMD-0801, 8 mg Once Daily - QD | 0 | 15 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B: ORMD-0801 8 mg Twice Daily - BID | 1 | 17 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B: ORMD-0801 16 mg Once Daily - QD | 1 | 18 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B: ORMD-0801 16 mg Twice Daily - BID | 0 | 15 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Excipient Matched Placebo -TID | 0 | 20 | 0 |
| other | Angina Pectoris | Cardiac disorders | Combined Cohort A + Cohort B: Matched Placebo | 0 | 82 | 0 |
1 to 10 of 495Source ClinicalTrials.gov
See all 495 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Cohort A + Cohort B: Matched Placebo | 0 | 82 |
| Total, all-cause mortality | Cohort A: ORMD-0801 Once Daily - QD | 0 | 69 |
| Total, all-cause mortality | Cohort A: ORMD-0801 Twice Daily - BID | 0 | 68 |
| Total, all-cause mortality | Cohort A: ORMD-0801 Three Times Daily - TID | 0 | 69 |
| Total, all-cause mortality | Cohort B:ORMD-0801, 8 mg Once Daily - QD | 0 | 15 |
| Total, all-cause mortality | Cohort B: ORMD-0801 8 mg Twice Daily - BID | 0 | 17 |
| Total, all-cause mortality | Cohort B: ORMD-0801 16 mg Once Daily - QD | 0 | 18 |
| Total, all-cause mortality | Cohort B: ORMD-0801 16 mg Twice Daily - BID | 0 | 15 |
| Total, all-cause mortality | Excipient Matched Placebo -TID | 1 | 20 |
| Total, other adverse events | Combined Cohort A + Cohort B: Matched Placebo | 11 | 82 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
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/NCT03467932
GET https://conductscience.org/api/trials/v1/NCT03467932/results?page=2