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Trial · NCT04606576

Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

NCT04606576, Phase 3, Terminated, Oramed, Ltd.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. Trials, record NCT04606576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04606576

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
NCT number
NCT04606576
Status
Terminated
Phases
Phase 3
Enrollment
710 participants, actual
Lead sponsor
Oramed, Ltd.
Conditions
Type 2 Diabetes Mellitus
Interventions
Placebo, ORMD-0801 QD, ORMD-0801 BD
First posted
2020-10-28
Last updated
2023-02-09

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMean change from baseline in A1CBaseline and 26 WeeksThe mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups.
SecondaryMean change in fasting glucoseBaseline and 26 weeksThe Mean change from baseline (Visit 1) in fasting plasma glucose at 26 weeks (Visit 6) will be analyzed using a linear mixed model similar to the primary analysis.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
8366922BACKGROUNDPubMed
16873813BACKGROUNDPubMed
17130504BACKGROUNDPubMed
31862745BACKGROUNDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT04606576

GET https://conductscience.org/api/trials/v1/NCT04606576/registered