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 Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes (NCT03015220), a randomized phase 3 study. The primary outcome is Number of Treatment-emergent Adverse Events (TEAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03015220 |
| Phase | Phase 3 |
| Condition | Diabetes, Diabetes Mellitus, Type 2 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 458 |
| Arms in the primary outcome | 4 |
| Lead sponsor | Novo Nordisk A/S |
| Results posted | Yes |
2. Clinical Question
Population
Japanese participants with type 2 diabetes were eligible for the trial context described in the registry record. The treatment was studied in combination with one oral antidiabetic drug. The safety analysis set comprised randomized participants who received at least one dose of trial product. The registry record does not report further eligibility details in the information summarized for this analysis.
Intervention
Oral semaglutide was studied in three dose groups: 3 mg, 7 mg, and 14 mg. Each was used in combination with one oral antidiabetic drug. The primary outcome counted treatment-emergent adverse events, rather than measuring a change in a diabetes-related laboratory value.
Comparator
The active comparator was dulaglutide 0.75 mg, also in combination with one oral antidiabetic drug. The trial was randomized and parallel-group, but masking was none. The registry record does not report additional details about how treatment assignment was implemented.
Primary question
The primary question was how many treatment-emergent adverse events were recorded in each treatment group from week 0 to week 57. This is a count of events, not a count of participants who experienced at least one event. The registry record also lists changes in HbA1c, glucose measures, body weight, body mass index, and waist circumference as secondary outcomes; those are distinct questions from the primary safety count.
3. Trial Design
This was a phase 3, randomized, open-label, parallel-group trial. The registry record describes a study of oral semaglutide versus dulaglutide, both used with one oral antidiabetic drug, in Japanese participants with type 2 diabetes. The four groups received oral semaglutide 3 mg, oral semaglutide 7 mg, oral semaglutide 14 mg, or dulaglutide 0.75 mg. Masking was none, so the record does not describe a blinded comparison.
Enrollment was 458. The primary safety outcome includes 131 participants in the oral semaglutide 3 mg group, 132 in the 7 mg group, 130 in the 14 mg group, and 65 in the dulaglutide 0.75 mg group. The primary outcome population is the safety analysis set: randomized participants who received at least one dose of trial product. These group sizes describe the analysis population for the posted primary results; the registry record does not provide further detail about exclusions or participant flow.
The trial started on 2017-01-10, and primary completion was 2018-07-12. Its status is completed. The primary outcome timeframe was weeks 0-57, described as a 52-week treatment period plus a 5-week follow-up period. Treatment-emergent events were defined in relation to onset during the on-treatment observation period. That period included time on trial product and any period after rescue medication was initiated.
The registry record does not report the allocation procedure, a sample-size justification, interim analyses, or a detailed statistical analysis plan. Those omissions limit what can be inferred about design choices beyond the randomized, parallel-group, open-label structure and the posted outcome definitions.
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: Data presented in "participant flow" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Overall Study
| Stage | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg |
|---|---|---|---|---|
| STARTED | 131 | 132 | 130 | 65 |
| Full Analysis Set (FAS) | 131 | 132 | 130 | 65 |
| Safety Analysis Set (SAS) | 131 | 132 | 130 | 65 |
| COMPLETED | 128 | 130 | 127 | 63 |
| NOT COMPLETED | 3 | 2 | 3 | 2 |
Reasons for not completing this period:
| Reason | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg |
|---|---|---|---|---|
| Withdrawal by Subject | 3 | 2 | 2 | 2 |
| Lost to Follow-up | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
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.
Population: The FAS comprised of all randomised participants.
| Characteristic | Unit | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 131 | 132 | 130 | 65 | 458 | |
| Age, Continuous | Years | 59 (SD 10) | 58 (SD 11) | 57 (SD 10) | 61 (SD 9) | 58 (SD 10) |
| Sex: Female, Male: Female | Participants | 31 | 42 | 30 | 14 | 117 |
| Sex: Female, Male: Male | Participants | 100 | 90 | 100 | 51 | 341 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 131 | 132 | 130 | 65 | 458 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 131 | 132 | 130 | 65 | 458 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Treatment-emergent Adverse Events (TEAEs), measured over Weeks 0-57.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of treatment-emergent adverse events recorded during weeks 0-57. An adverse event counted as treatment-emergent when its onset occurred during the on-treatment observation period. The registry definition includes time while a participant was receiving trial product, including any period after rescue medication began. The timeframe is described as a 52-week treatment period plus a 5-week follow-up period.
This outcome is a count of events. It is not the same as the number of participants with an event: one participant may contribute more than one event, so the event count alone does not show how many people were affected. General statistical context: event counts can describe the total burden of recorded events, but interpretation depends on the event definition, observation period, and how repeated events are handled. The registry record does not report a further rule for repeated events in the information.
The outcome is used to characterize safety during treatment and follow-up. The registry record posts the count in each treatment group but does not provide a spread measure, confidence interval, or two-arm comparison for this primary count outcome. The group counts therefore describe what was recorded, but do not by themselves quantify the precision of a difference between treatments.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary results are event counts: 330 in the oral semaglutide 3 mg group, 350 in the 7 mg group, 324 in the 14 mg group, and 178 in the dulaglutide 0.75 mg group. The analyzed group sizes were 131, 132, 130, and 65, respectively. These are counts of treatment-emergent adverse events, not counts of participants with at least one event. They should not be read as participant-level risks or as a direct estimate of the difference in the probability that a participant experiences an event.
The registry record does not post an uncertainty interval, dispersion measure, or inferential comparison for the primary event counts. It also does not report an adjusted estimate for a contrast among these groups. Consequently, the raw counts alone do not establish whether the underlying event experience differed between treatments, or how precisely any such difference could be estimated. The safety observation period and the group sizes are not identical across groups, which are relevant context when interpreting raw event totals; the record does not provide an exposure-adjusted count comparison.
Separate posted safety summaries count participants with serious adverse events and participants with other adverse events. Those are participant counts, not the primary endpoint’s total event counts, and they answer a different descriptive question. The serious-event counts were 9, 4, 7, and 1 across the semaglutide 3 mg, 7 mg, and 14 mg groups and the dulaglutide group, respectively. The corresponding counts with other adverse events were 65, 79, 84, and 36. No deaths were recorded in these groups. These figures are descriptive and do not, without uncertainty estimates and a stated comparative analysis, establish a treatment difference.
The posted secondary comparison for participants with treatment-emergent severe or blood-glucose-confirmed symptomatic hypoglycaemic episodes reports a risk difference of -< 0.001 for semaglutide 7 mg versus semaglutide 3 mg, with a confidence interval from -0.036 to 0.036 and an unadjusted p-value of 0.992. For semaglutide 14 mg versus semaglutide 3 mg, the reported risk difference is 0.008, with a confidence interval from -0.031 to 0.047 and an unadjusted p-value of 0.694. Both intervals include zero and are compatible with differences in either direction. The estimates are imprecise for interpreting small differences, and the unadjusted p-values do not account for the many outcomes and analyses listed in the record.
These secondary comparisons do not replace the primary safety count. They concern a specific participant-level hypoglycaemia outcome and compare semaglutide doses with the 3 mg semaglutide group, not with dulaglutide. The registry record does not post a comparison for every possible pair of treatment groups for this endpoint. The reported results support descriptive reading of the measured outcomes, rather than a definitive ranking of treatments.
9. Statistical Methods Explained
General statistical context: a trial’s design determines what kinds of comparisons are possible, while its analysis population and outcome definition determine what each estimate represents. This trial is described as randomized, parallel-group, and open-label. Randomization is intended to reduce systematic differences between groups at allocation, but the registry record does not report the allocation method or details needed to assess its implementation. Open-label means masking was none in the record; the record does not describe procedures to mitigate any effects that lack of masking might have on reporting or assessment.
What does a count outcome represent?
The primary outcome counts treatment-emergent adverse events over weeks 0-57. The reported values are events, while the group denominators refer to participants in the safety analysis set. These are different units. A count can include multiple events from a participant; a participant count records whether a person met a specified condition. It is therefore not appropriate to interpret the primary counts as if they were the number of people affected. The registry record gives no spread measure or confidence interval for these event counts, and does not report an inferential method for comparing them.
General statistical context: count outcomes may be analyzed with methods that account for unequal observation time and for variability greater than a simple count model expects. Over-dispersion means that observed counts vary more than the model’s assumptions would predict; failing to account for it can make uncertainty estimates misleading. This is general explanation, not a description of the method used in this trial. The registry record does not report a count-model specification, an exposure adjustment, or an over-dispersion assessment for the primary outcome.
How should the secondary risk differences be read?
The posted hypoglycaemia comparisons give unadjusted risk differences between semaglutide 7 mg and 3 mg, and between semaglutide 14 mg and 3 mg. A risk difference expresses the difference between the observed proportions in the two groups. General statistical context: a confidence interval conveys a range of values compatible with the data under the interval procedure; it does not guarantee that the true value lies in that range. Both posted intervals include zero, so the results are compatible with no difference as well as with effects in either direction. The record does not state the confidence level in the details summarized for these comparisons.
The associated p-values are unadjusted. A p-value measures how surprising data at least as incompatible with a specified null hypothesis would be under that hypothesis and the test assumptions. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. The registry record does not report a multiplicity adjustment for these comparisons. The p-values therefore should be treated as exploratory evidence rather than as a complete account of all statistical uncertainty.
What do the planning illustrations mean?
Planning illustrations are included for the two posted risk-difference comparisons. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustrations consider detecting the stated fraction of the observed effect. They are planning scenarios based on the observed effect, not the trial’s own design justification and not observed power. General statistical context: planning estimates based on an observed effect can be unstable, especially when that estimate is small or imprecise. The registry record does not report that these assumptions were used to design the trial.
For the 7 mg comparison, the illustration lists 11,626,918 participants per arm for 80% power and 15,565,143 for 90% power when planning for 100% of the observed effect. For 75% of the observed effect, the corresponding figures are 20,689,266 and 27,697,056; for 50%, they are 46,594,022 and 62,376,175. For the 14 mg comparison, the corresponding figures are 6,621 and 8,863 for 100% of the observed effect, 11,351 and 15,195 for 75%, and 24,593 and 32,922 for 50%. These are participants per arm in hypothetical planning scenarios, not numbers enrolled or observed in this trial. The very different illustrations across comparisons reflect how strongly such calculations depend on the effect estimate used.
The registry record does not report whether the secondary comparisons were prespecified, which analysis methods were used beyond the posted results, how missing observations were handled, or whether any interim analyses occurred. In the absence of those details, interpretation should stay close to the reported estimands, counts, intervals, and unadjusted p-values rather than assuming a particular model or analysis strategy.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists many outcomes and analyses, but does not report a multiplicity-control procedure for the posted secondary comparisons. This matters because testing multiple outcomes or contrasts can increase the chance of at least one apparently notable result even when no corresponding effect exists. The unadjusted p-values for the posted hypoglycaemia comparisons should therefore not be treated as if they were adjusted confirmatory tests. The record does not report which outcomes, contrasts, or testing sequence were prespecified.
Missing-data methods are not reported in the registry record. The record does not explain how participants with missing endpoint observations were handled, whether outcomes were imputed, or whether sensitivity analyses assessed assumptions about missingness. These details can affect interpretation, especially for outcomes measured over an extended follow-up period. No conclusions about the direction or magnitude of any resulting bias can be drawn from the reported information.
The primary analysis population is defined as the safety analysis set, comprising randomized participants who received at least one dose of trial product. The primary event counts are reported for that population. The registry record does not provide additional participant-flow details or explain whether other analysis populations were used for efficacy outcomes. It also does not report an interim-analysis plan, a sample-size justification, or a detailed statistical analysis plan. These absences do not establish that a particular method was or was not used; they mean the method is not reported in the registry record.
General statistical context: multiplicity, missing data, and analysis-population definitions concern different sources of uncertainty. Multiplicity affects how a set of tests is interpreted; missingness concerns which outcome information contributes to an analysis; and the analysis population defines who is represented by the estimate. Without reported methods on these points, the posted results can be described, but the analysis cannot be fully reconstructed or independently assessed from the registry record alone.
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 |
|---|---|---|---|
| Oral Semaglutide 3 mg | 9 | 131 | 6.9% |
| Oral Semaglutide 7 mg | 4 | 132 | 3.0% |
| Oral Semaglutide 14 mg | 7 | 130 | 5.4% |
| Dulaglutide 0.75 mg | 1 | 65 | 1.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Oral Semaglutide 3 mg | 0 of 131 |
| Oral Semaglutide 7 mg | 0 of 132 |
| Oral Semaglutide 14 mg | 0 of 130 |
| Dulaglutide 0.75 mg | 0 of 65 |
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 |
|---|---|
| Oral Semaglutide 3 mg | 65 of 131 |
| Oral Semaglutide 7 mg | 79 of 132 |
| Oral Semaglutide 14 mg | 84 of 130 |
| Dulaglutide 0.75 mg | 36 of 65 |
Most frequent serious adverse event terms
| Event term | Organ system | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | 0 of 131 | 0 of 132 | 1 of 130 | 1 of 65 |
| Large intestine polyp | Gastrointestinal disorders | 1 of 131 | 1 of 132 | 0 of 130 | 0 of 65 |
| Acute myocardial infarction | Cardiac disorders | 1 of 131 | 0 of 132 | 0 of 130 | 0 of 65 |
| Appendicitis | Infections and infestations | 1 of 131 | 0 of 132 | 0 of 130 | 0 of 65 |
| Atrioventricular block second degree | Cardiac disorders | 0 of 131 | 0 of 132 | 0 of 130 | 1 of 65 |
| Cardiac ablation | Surgical and medical procedures | 1 of 131 | 0 of 132 | 0 of 130 | 0 of 65 |
| Cellulitis | Infections and infestations | 0 of 131 | 0 of 132 | 1 of 130 | 0 of 65 |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 131 | 1 of 132 | 0 of 130 | 0 of 65 |
| Diabetic retinopathy | Eye disorders | 1 of 131 | 0 of 132 | 0 of 130 | 0 of 65 |
| Femoral neck fracture | Injury, poisoning and procedural complications | 0 of 131 | 1 of 132 | 0 of 130 | 0 of 65 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 34 of 131 | 39 of 132 | 39 of 130 | 19 of 65 |
| Constipation | Gastrointestinal disorders | 12 of 131 | 16 of 132 | 20 of 130 | 6 of 65 |
| Nausea | Gastrointestinal disorders | 7 of 131 | 11 of 132 | 12 of 130 | 6 of 65 |
| Diabetic retinopathy | Eye disorders | 6 of 131 | 12 of 132 | 5 of 130 | 2 of 65 |
| Influenza | Infections and infestations | 9 of 131 | 9 of 132 | 5 of 130 | 2 of 65 |
| Decreased appetite | Metabolism and nutrition disorders | 0 of 131 | 12 of 132 | 6 of 130 | 3 of 65 |
| Abdominal discomfort | Gastrointestinal disorders | 3 of 131 | 6 of 132 | 9 of 130 | 1 of 65 |
| Diarrhoea | Gastrointestinal disorders | 2 of 131 | 2 of 132 | 10 of 130 | 4 of 65 |
| Back pain | Musculoskeletal and connective tissue disorders | 4 of 131 | 5 of 132 | 3 of 130 | 4 of 65 |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | 4 of 131 | 4 of 132 | 3 of 130 | 5 of 65 |
Serious events with the highest arm-level rate: angina pectoris (1.5%), atrioventricular block second degree (1.5%), cellulitis (0.8%), gastrointestinal inflammation (0.8%), osteomyelitis (0.8%).
The serious adverse event summaries report participants affected, not the total number of serious events. The counts were 9 in the oral semaglutide 3 mg group, 4 in the 7 mg group, 7 in the 14 mg group, and 1 in the dulaglutide 0.75 mg group. The registry record lists zero deaths in each group. These figures are descriptive counts within the safety analysis groups; they are not adjusted comparisons and do not establish a difference in risk.
The record also lists participants with other adverse events: 65, 79, 84, and 36 across those same groups. These counts are separate from the primary endpoint, which counts all treatment-emergent adverse events rather than participants affected. The record lists serious-event terms including angina pectoris and atrioventricular block second degree at 1.5%, and cellulitis, gastrointestinal inflammation, osteomyelitis, and prostate cancer at 0.8%. The denominator and further context for those term percentages are not reported in the registry record, so they should not be interpreted as comparative rates.
General statistical context: rare or uncommon serious events can be difficult to compare precisely in groups of this size, and a difference in raw counts may reflect uncertainty as well as underlying risk. The registry record does not post uncertainty intervals or a formal comparative analysis for these serious-event figures. They describe the recorded safety experience; they do not, by themselves, establish whether one treatment is safer than another.
12. What the Result Does, and Does Not, Mean
The posted primary results describe the number of treatment-emergent adverse events recorded in each treatment group during weeks 0-57. They show that the registry record contains 330 events for oral semaglutide 3 mg, 350 for 7 mg, 324 for 14 mg, and 178 for dulaglutide 0.75 mg. They also show the number of participants in the safety analysis set for each group. Because the outcome is an event count and not a participant risk, the counts should be interpreted in their stated units.
The results do not establish that one treatment caused more or fewer events than another. The record does not provide an uncertainty interval, spread measure, exposure-adjusted estimate, or inferential comparison for the primary count outcome. Without those, the precision of a difference cannot be assessed from the raw counts alone. The smaller dulaglutide group is also relevant context for reading its raw count alongside counts from the semaglutide groups.
The posted secondary hypoglycaemia comparisons do not establish a difference in either direction. Their confidence intervals include zero, and their p-values are unadjusted. Those comparisons concern semaglutide doses relative to semaglutide 3 mg; they do not compare these doses with dulaglutide. They also do not speak for all secondary outcomes listed in the record.
General statistical context: a result that is imprecise is not proof of equivalence, and a lack of a statistically notable result is not proof of no effect. Equivalence or non-inferiority requires a defined margin and an appropriate analysis; such a margin and analysis are not reported in the registry record. Likewise, the planning illustrations are not evidence about achieved power or the trial’s original design rationale. They are hypothetical planning calculations based on observed effects and stated assumptions.
These results are a statistical description of the posted registry record, not medical advice. They do not establish overall benefit, harm, or treatment preference. Such judgments would require a broader clinical assessment and evidence beyond the descriptive and unadjusted results recorded.
13. Why This Trial Matters Statistically
Statistically, this trial illustrates why the outcome’s unit must be clear. Its primary endpoint is the total number of treatment-emergent adverse events, whereas several safety summaries count participants affected. An event total and a participant count are not interchangeable. Readers who overlook that distinction could mistake a larger event count for a larger number of people experiencing an event, which the primary endpoint does not report.
The trial also demonstrates the limits of interpreting raw counts across groups with different sizes. The registry record gives the analyzed group sizes and event counts, but does not post a comparative estimate or uncertainty measure for the primary count outcome. That leaves the magnitude and precision of any group difference unresolved. For a complete comparative interpretation, the model, handling of exposure time, and uncertainty estimates would be useful; these are not reported in the registry record.
The secondary comparisons illustrate a related issue: intervals can include zero while still allowing differences in either direction. Their unadjusted p-values are only part of the evidence, particularly alongside the many outcomes listed in the record. The planning illustrations further show that hypothetical sample-size requirements depend on the effect used for planning and should not be confused with observed power or the original trial justification.
The value of the record is therefore descriptive: it identifies the trial structure, outcome definitions, analysis population, event counts, and selected secondary comparisons. Its statistical limits are equally important. The missing details on multiplicity, missing data, analysis methods, and primary-outcome uncertainty prevent stronger comparative claims from being supported by the posted information alone.
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.
Several limitations specific to this trial affect interpretation of the posted results. The study was open-label, with masking recorded as none. The registry record does not report how outcome assessment or event reporting may have been protected from knowledge of treatment assignment. This is relevant context for safety outcomes based on recorded adverse events, although the record does not allow the direction or size of any effect to be determined.
The primary endpoint is a count of events, but no dispersion measure, confidence interval, or comparative estimate is posted for it. The group sizes differ, and the registry record does not report an exposure-adjusted analysis of the counts. Raw counts therefore offer limited information about comparative event burden or precision. In addition, the primary outcome period includes treatment and follow-up, while the event definition is based on onset during the on-treatment observation period, including time after rescue medication begins. Interpretation should follow that stated definition rather than assuming a simpler treatment-only window.
The registry record does not report a detailed statistical plan, sample-size justification, interim-analysis plan, multiplicity procedure, or missing-data methods. It also does not provide the full numerical results for every secondary outcome in the information summarized for this analysis. These omissions limit assessment of prespecification, analytic choices, and the consistency of findings across outcomes.
The secondary hypoglycaemia comparisons are unadjusted and involve semaglutide dose groups compared with semaglutide 3 mg. They do not provide a complete set of comparisons against dulaglutide, and their confidence intervals include zero. The planning illustrations are based on the observed effects and stated assumptions, not the trial’s own design. These limitations mean the record supports careful description of the results, not a definitive comparative conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes — NCT03015220.
- Registry record last updated 2021-03-02; status last verified 2021-02.
- Results first posted 2019-12-30.
- 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.
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18. Record Summary
NCT03015220 is a completed phase 3 randomized, open-label, parallel-group trial of oral semaglutide versus dulaglutide, both in combination with one oral antidiabetic drug, in Japanese participants with type 2 diabetes. The groups received oral semaglutide 3 mg, 7 mg, or 14 mg, or dulaglutide 0.75 mg. Enrollment was 458. The trial started on 2017-01-10, and primary completion was 2018-07-12.
The primary outcome was the number of treatment-emergent adverse events recorded over weeks 0-57. The safety analysis set comprised randomized participants who received at least one dose. The registry record posts event counts by group but does not report a comparative estimate or uncertainty measure for the primary count outcome. It also lists metabolic, glucose, and body-size secondary outcomes, with selected unadjusted hypoglycaemia comparisons. Details on multiplicity, missing-data methods, and the full statistical plan are not reported in the registry record.