Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04564846 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT04564846: Completed Phase 2 study of Diabetes Mellitus, Type 2, sponsored by Oramed.
NCT04564846 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by Oramed. The registered enrollment target is 49 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04564846, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime
Primary Outcome
The endogenous glucose production in ORMD-0801 and placebo measured by the glucose with tracer attached using AUC(0-16) as the primary parameter. The intravenous infusion of \[6,6-2H2\]-glucose tracer is administered following administraiton of either placebo or intervention. The pharmacokinetic time points are basline (pre dose), 0.75 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 hr, 12 hr, 13 hr, 14 hr, 15 hr, 16 hr post-dose.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ORMD-0801
Study Locations (1)
California
- Orange County Research Center (OCRC) 14351 Myford Rd., Suite B, Tustin, CA 92780 - Tustin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 2 |
What the finished NCT04564846 record still lists
NCT04564846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04564846 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04564846 about?
NCT04564846 is a clinical study titled "A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus". This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after t...
What is the current status of trial NCT04564846?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2020-11-23. Estimated completion is 2022-06-07.
What conditions does trial NCT04564846 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT04564846?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 (DRUG).
Who is sponsoring clinical trial NCT04564846?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04564846 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04564846's enrollment target sits among peer trials
49 264th of 348 higher than 83 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
DETERMINE: Detemir vs NPH
RECRUITING · Phase 2
-
MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
RECRUITING · Phase 2
-
A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
RECRUITING · Phase 2
-
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
RECRUITING · Phase 2
-
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
ACTIVE NOT RECRUITING · Phase 2
-
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02704858 · 49 participants · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
- NCT03516708 · 49 participants · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- NCT03692429 · 49 participants · Phase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
- NCT04329494 · 49 participants · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI