This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results 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 (NCT02094534), a randomized phase 2 study. The primary outcome is Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02094534 |
| Phase | Phase 2 |
| Condition | Diabetes Mellitus Type 1 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oramed, Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
People with established type 1 diabetes who met the study’s eligibility criteria. The primary outcome description names an intend-to-treat population. The registry does not report further participant characteristics in the posted results.
Intervention
ORMD-0801 capsules, described as recombinant human insulin in Oramed’s proprietary capsule formulation.
Comparator
Placebo capsules, described as fish oil capsules identical in appearance to ORMD-0801.
Primary question
How did total, basal, and bolus exogenous insulin requirements change from the run-in average to treatment, comparing participants treated with ORMD-0801 with participants treated with placebo?
The primary outcome description defines baseline as the average over run-in days 1-7 and treatment as the average of day 6 and day 7. It therefore frames the question as a comparison of change between the treatment groups over the specified periods, rather than as a comparison of a single glucose measurement. The registry also lists mean nighttime, daytime, and fasting glucose levels as secondary outcomes.
The record does not include a reported estimate of the primary outcome or a statistical comparison between groups. It is therefore possible to describe the intended question and its measurement schedule, but not to determine from the posted results what changes were observed or how uncertain a between-group estimate would be. The clinical question is also limited to the trial’s stated setting and enrolled participants; the registry does not give enough participant detail to characterize how closely they represent other populations with type 1 diabetes.
3. Trial Design
The registry describes a randomized, parallel-group, placebo-controlled Phase 2 study. Its title calls the study double-blind, while the registry classifies masking as quadruple. The record does not explain which people or roles were masked, how masking was maintained, or how random allocation was implemented. The sponsor is Oramed, Ltd. The study status is completed, with enrollment recorded as 25.
Participants were to be screened against inclusion and exclusion criteria and admitted to an inpatient unit after screening. The brief description says participants reported to the unit at 6 a.m., received a continuous glucose monitoring device, and were given standardized meals and snacks during the inpatient visit. These conditions are relevant context for interpreting the glucose outcomes: they describe a controlled inpatient assessment, not ordinary daily life. The registry does not report further details about the length of each inpatient visit or the complete treatment schedule.
The two named interventions were ORMD-0801 capsules and placebo capsules. ORMD-0801 is described as recombinant human insulin in a proprietary formulation; placebo is described as fish oil in capsules identical in appearance. The primary outcome description identifies an intend-to-treat population. Safety figures list 15 participants at risk in the ORMD-0801 group and 10 in the placebo group. The record does not explain the relationship between these safety groups and the enrollment figure, or report a participant flow account.
The study start is recorded as 2014-03, and primary completion as 2014-08. Although the study is marked completed, the registry record contains no primary outcome analysis entries. Further protocol details, including the planned statistical analysis and any sample-size justification, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Basal Exogenous Insulin - Intend to Treat (ITT) - All Subjects
Overall Study
| Stage | ORMD-0801 | Placebo |
|---|---|---|
| STARTED | 15 | 10 |
| COMPLETED | 15 | 10 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intend-to-treat polpulation
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | ORMD-0801 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 10 | 25 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 15 | 10 | 25 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 38.90 (SD 11.936) | 37.61 (SD 9.642) | 38.255 (SD 15.343) |
| Sex: Female, Male: Female | Participants | 3 | 5 | 8 |
| Sex: Female, Male: Male | Participants | 12 | 5 | 17 |
| Region of Enrollment: United States | participants | 15 | 10 | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements, measured over Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled “Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements.” It is intended to describe changes in externally administered insulin requirements, separated into total, basal, and bolus measures. The stated baseline is the run-in average over days 1-7. The treatment value is the average of day 6 and day 7, and the endpoint description calls for comparing change between participants treated with ORMD-0801 and those treated with placebo.
In general, a change-from-baseline endpoint uses each participant’s starting measurement as a reference, then evaluates how the measure changes during treatment. Comparing the changes between randomized groups can help distinguish a treatment-period pattern from changes that might also occur under the comparator. The endpoint’s average across the specified treatment days is intended to represent those days together, rather than rely on a single day.
The registry lists mg/dL as the endpoint unit, even though the outcome title refers to insulin requirements. That reporting detail creates uncertainty about how the measure is expressed; the record does not clarify it. It also does not provide the observed endpoint values, group estimates, measures of variability, or an inferential comparison. Consequently, the endpoint’s intended meaning can be described, but its magnitude and precision cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes that the study was designed to compare changes in exogenous insulin requirements between ORMD-0801 and placebo groups. It does not report the primary outcome analysis. In particular, there is no posted numerical change for total, basal, or bolus requirements, no between-group estimate, and no uncertainty interval or p value. The direction, size, and precision of the primary result therefore cannot be determined from the registry record.
This absence matters because a description of the planned endpoint is not itself evidence of an observed effect. The endpoint specifies which measurements were meant to be compared and when they were intended to be taken. It does not establish what happened to participants’ measurements. Nor can the completed status of the trial substitute for an outcome estimate: completion indicates a registry status, not whether an analysis was performed or what it found.
The registry reports enrollment of 25 and lists safety groups of 15 for ORMD-0801 and 10 for placebo. Those are participant counts, not outcome estimates. Without a participant flow description and analysis results, it is not possible to tell from this record how many participants contributed data to the primary analysis, whether any measurements were missing, or whether the groups in the primary analysis matched the named safety groups.
The primary outcome is reported as a mean with standard deviation as the dispersion measure. In general, a mean describes the average measurement in a group, while a standard deviation describes how spread out individual measurements are around that average. Neither is presented as a numerical primary result in the record. A standard deviation would describe variation among measurements; it would not by itself quantify the precision of a comparison between groups.
For a treatment comparison, an estimate and its confidence interval would be useful together: the estimate conveys the observed contrast, while the interval conveys a range of values compatible with the data under the analysis assumptions. Neither is available in the posted outcome information. No conclusion about statistical evidence or the practical size of a difference should be inferred from the design description alone.
The record lists mean nighttime, daytime, and fasting glucose levels as secondary outcomes, but does not report their results. It also indicates that the primary outcome has several categories or time points and was not reduced to a single comparison. This makes it especially important not to invent a single summary result from an outcome whose separate components are not reported. The outcome analysis, any component-specific comparisons, and their uncertainty are not reported in the registry record.
Sample-size calculations described as planning illustrations are not observed trial findings. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect expressed as a fraction of the observed effect. The record does not state the resulting participant counts in the registry record for this interpretation, and it does not report a numerical observed effect to evaluate. Such illustrations cannot establish that the trial had a particular probability of detecting an effect. They are not observed power and do not replace the missing outcome analysis.
9. Statistical Methods Explained
The endpoint is described as a mean of a continuous measure, with standard deviation as its dispersion. In general, a continuous outcome can take a range of values rather than belonging to a fixed set of categories. A mean provides a concise description of a group’s average, while the standard deviation conveys how much individual observations vary around that average. Those summaries answer different questions: the mean concerns the group’s central level, and the standard deviation concerns the spread of observed values.
The endpoint is a change from baseline. In general, change scores compare a participant’s measurement at a later assessment with a reference measurement from an earlier period. Here, baseline is defined as the run-in average over days 1-7, and the treatment measurement is defined as the average of day 6 and day 7. The stated comparison is between changes in the ORMD-0801 and placebo groups. However, the registry does not report the formula used to form each participant’s change, the group-level estimates, or a model for comparing groups. The endpoint description is not a substitute for those analysis details.
Random allocation is intended, in general, to create groups that can be compared without choosing treatment according to participant characteristics. A placebo comparator can help distinguish changes associated with the intervention from changes that occur under the comparison condition. These design features support interpretation of a between-group comparison when allocation and outcome analyses are adequately documented. In this record, the allocation method, concealment procedures, and implementation details are not reported in the registry record. The title says double-blind and the masking classification says quadruple, but the record does not identify the masked roles or explain the difference in wording.
The primary outcome includes total, basal, and bolus insulin requirements. These are distinct outcome components, so a single overall summary might not capture every component’s pattern. The registry’s note that the primary outcome has several categories or time points and was not reduced to one comparison is important: no single numerical contrast can be attributed to the primary outcome from the posted results. In general, when an outcome has multiple components or repeated assessments, a statistical plan should specify which contrasts are primary and how any additional comparisons will be interpreted. That plan is not reported in the registry record.
In general, multiplicity arises when several statistical comparisons are made. Looking at multiple outcomes, time points, or components can increase the chance that at least one result appears notable by chance if all are treated as independent opportunities for a finding. This does not mean every multi-part endpoint is invalid; it means the analysis plan and interpretation should identify the intended primary comparison and explain how other tests are handled. The record lists secondary glucose outcomes and a multi-part primary endpoint, but does not report a multiplicity strategy or a complete list of statistical tests.
A confidence interval is, in general, a way to express the uncertainty around an estimated quantity. It indicates which values are reasonably compatible with the data under the method’s assumptions, rather than proving that any one value is correct. The registry record contains no numerical primary estimate or confidence interval. A p value, if reported, would address compatibility with a specified null model under its assumptions; it would not show the magnitude or clinical importance of an effect. No primary p value is reported in the registry record.
Standard deviation should not be confused with standard error. In general, standard deviation describes variability among individual observations, whereas standard error describes uncertainty in an estimated statistic. A group standard deviation alone would not communicate the precision of a treatment contrast. A contrast’s precision also depends on the analysis and available observations. Since the record does not report the outcome summaries, analysis sample, or comparison model, the precision of the primary result cannot be reconstructed.
Over-dispersion is a general concern when observed variability exceeds what an assumed statistical model allows. If present and ignored, standard errors and resulting uncertainty measures may be unreliable. That concept is not specific evidence about this study: the registry does not report a model fit, an over-dispersion assessment, or any diagnostic results. The posted endpoint is continuous, and the record names standard deviation as its descriptive measure, but this alone does not indicate whether a particular model was appropriate.
The registry’s sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect for the illustration is stated as a fraction of the observed effect. In general, such calculations ask how many participants per arm would be needed under specified assumptions to target a chosen power for a chosen effect. They are planning scenarios, not evidence that the actual study achieved that power. The registry does not report its own sample-size justification, the resulting illustrative counts in the registry record for this account, or the statistical rationale used to select the trial enrollment.
The primary outcome names an intend-to-treat population. In general, an intention-to-treat approach analyzes participants according to their randomized assignment, regardless of treatment adherence, preserving the comparison created by randomization. The exact wording in this record is “Intend-to-treat population,” and the analysis details are not reported. It is therefore not possible to confirm how the population was operationalized, how missing measurements were handled, or whether other analysis populations were used.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint includes total, basal, and bolus exogenous insulin requirements and specifies a run-in baseline and treatment-day average. Mean nighttime, daytime, and fasting glucose levels are also listed as secondary outcomes. These multiple components and outcomes create several possible comparisons. The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not report a hierarchy of tests, a multiplicity adjustment, or another strategy for interpreting multiple analyses. Those choices are not reported in the registry record.
The primary outcome description names an intend-to-treat population, but the record does not define the analysis population in detail. It does not report how participants were handled if they did not complete treatment or lacked endpoint measurements, whether any measurements were imputed, or what missing-data assumptions were used. A participant flow account and numbers contributing to each analysis are also not reported. Without these details, readers cannot evaluate the extent or handling of missing data or determine whether the analysis followed the named population consistently.
The record reports no primary analysis entries. It therefore provides no effect estimate, confidence interval, or p value with which to assess the primary comparison. Any sample-size illustrations based on an effect and specified assumptions are planning aids, not observed power and not a substitute for results. The registry does not report the trial’s own sample-size justification or a detailed statistical analysis plan. These omissions limit assessment of how outcome selection, multiplicity, analysis populations, and missing observations were addressed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| ORMD-0801 | 0 | 15 | 0.0% |
| Placebo | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ORMD-0801 | 0 of 15 |
| Placebo | 0 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| ORMD-0801 | 15 of 15 |
| Placebo | 10 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ORMD-0801 | Placebo |
|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | 15 of 15 | 10 of 10 |
| Hyperglycemia | Metabolism and nutrition disorders | 13 of 15 | 9 of 10 |
| Headache | Nervous system disorders | 2 of 15 | 1 of 10 |
| Vision blurred | Eye disorders | 1 of 15 | 0 of 10 |
| Abdominal Pain | Gastrointestinal disorders | 0 of 15 | 1 of 10 |
| Nausea | Gastrointestinal disorders | 1 of 15 | 0 of 10 |
| Fatigue | General disorders | 1 of 15 | 0 of 10 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 15 | 1 of 10 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 0 of 15 | 1 of 10 |
| Dizziness | Nervous system disorders | 1 of 15 | 0 of 10 |
The registry reports serious adverse events for the two listed groups. For ORMD-0801, 15 participants were at risk, 0 had a serious adverse event, and deaths were 0. For placebo, 10 participants were at risk, 0 had a serious adverse event, and deaths were 0. These are the posted serious-event and death figures; they do not describe the primary endpoint or establish a treatment effect.
The registry also reports other adverse-event figures: 15 participants at risk and 15 affected in the ORMD-0801 group, and 10 at risk and 10 affected in the placebo group. The record does not provide further details about the nature, severity, timing, or number of event episodes in these figures. They should be read as participant counts in the registry categories, not as a description of specific events.
In general, a count of zero reported serious events is not evidence that no risk exists. Interpretation depends on how events were collected, the observation period, the number of participants assessed, and the completeness of reporting. The registry does not provide enough detail to characterize those aspects or to make a broader safety comparison. The figures should be understood as the reported counts for this study, rather than as a comprehensive estimate of risk.
12. What the Result Does, and Does Not, Mean
The registry describes a randomized comparison of ORMD-0801 capsules with placebo and specifies a primary outcome focused on change in exogenous insulin requirements. It also identifies a structured inpatient setting, continuous glucose monitoring, standardized meals and snacks, and a treatment-period average based on day 6 and day 7. These details explain the intended design and measurement context.
What the record does not establish is the observed primary result. It contains no reported outcome analysis entries, numerical group changes, between-group estimate, confidence interval, or p value. Thus, the direction and size of any difference, and the precision with which it was estimated, are not reported in the registry record. The completed status and enrollment figure do not fill that gap.
The record also does not establish how the primary result related to total, basal, or bolus requirements individually, or what the secondary glucose outcomes showed. Nor does it report how missing measurements, multiple comparisons, or deviations from the intended analysis population were handled. The primary outcome’s listed unit is mg/dL, while its title refers to insulin requirements; the registry does not clarify this apparent reporting ambiguity.
In general, evidence from a randomized trial is interpreted through the observed outcome estimates and their uncertainty, alongside the design and analysis details. Here, the design can be described, but the result cannot be judged for magnitude, precision, or statistical evidence using the registry information available. This account does not imply that the intervention did or did not change insulin requirements, and it does not support a medical recommendation. It distinguishes the study’s stated question from findings that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises several useful statistical issues because its primary outcome is not a single, fully specified measurement. It includes total, basal, and bolus exogenous insulin requirements, and it compares a run-in average with an average of treatment days. The registry also notes multiple categories or time points and does not reduce them to one comparison. That makes the definition of the target contrast especially important: different components can answer related but not identical questions.
The design also illustrates why outcome results need to be read alongside analysis details. The record identifies randomization, a placebo group, and an intend-to-treat population, but gives no analysis entries, results, or missing-data procedures. Without those, a reader cannot assess whether the reported analysis preserved the intended comparison or how precisely it estimated a difference. The study’s completed status alone cannot answer those questions.
The controlled inpatient context is another relevant statistical feature. Continuous glucose monitoring and standardized meals and snacks may reduce variation in how measurements are collected during the visit. In general, standardized conditions can make measurements more comparable within a study, while also limiting how directly those measurements represent other settings. The registry does not provide the outcome data needed to assess the consequences in this trial.
Finally, the record lists planning assumptions for sample-size illustrations, but does not report the study’s own sample-size justification or a primary analysis. Separating a planning calculation from observed evidence is essential: an assumed effect used to illustrate a design is not a finding, and a calculated power scenario is not observed power. This distinction is particularly important when the posted results do not include an estimate of the effect being studied.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation of interpreting this record is that it contains no primary outcome analysis entries. The intended comparison is described, but numerical outcome estimates and measures of uncertainty are not reported in the registry record. The same is true for the listed secondary glucose outcomes. As a result, the study’s findings cannot be assessed from these posted results.
The endpoint description includes total, basal, and bolus insulin requirements and refers to change from a run-in average to a treatment-day average. The registry states that the outcome has several categories or time points and was not reduced to one comparison. It does not report how each component was analyzed, which contrast was designated as the main inferential test, or how multiple comparisons were addressed.
The listed unit is mg/dL, although the endpoint title concerns insulin requirements. The record does not clarify the measurement or unit convention, leaving uncertainty about the scale on which the endpoint was intended to be interpreted. It also does not report the statistical model, missing-data method, analysis sample size for the primary outcome, participant flow, or detailed definition of the intend-to-treat population.
Enrollment is recorded as 25, and the safety groups list 15 participants at risk for ORMD-0801 and 10 for placebo. The record does not explain whether these counts represent all randomized participants or how they relate to the primary analysis population. The brief description places assessments in an inpatient setting with standardized meals and snacks, but further details of the assessment schedule and treatment exposure are not reported. The findings’ relevance beyond that setting cannot be evaluated from the record, especially in the absence of outcome results.
The study is identified as Phase 2, but its sample-size justification and detailed analysis plan are not reported in the registry record. The available planning assumptions do not establish the study’s actual power or resolve the absence of results. Safety reporting is likewise limited to aggregate counts without event descriptions or further collection details.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 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 — NCT02094534.
- Registry record last updated 2017-07-06; status last verified 2017-06.
- Results first posted 2017-07-06.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed Phase 2 study randomized participants with type 1 diabetes to ORMD-0801 capsules or placebo. Enrollment is recorded as 25. The primary outcome concerns change in total, basal, and bolus exogenous insulin requirements from the run-in average over days 1-7 to the average of treatment day 6 and day 7. The registry lists mean nighttime, daytime, and fasting glucose levels as secondary outcomes.
The primary outcome names an intend-to-treat population, but the registry contains no primary analysis entries or numerical outcome results. The endpoint unit is listed as mg/dL, and the record does not clarify that unit in relation to the stated insulin-requirement measure. Serious adverse events and deaths are reported as 0 in both listed groups; other adverse-event counts are reported for each group. Detailed analysis methods, missing-data handling, and the trial’s own sample-size justification are not reported in the registry record.