Liraglutide and Peripheral Artery Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Liraglutide and Peripheral Artery Disease (NCT04881110), a randomized phase 4 study. The primary outcome is Peripheral Transcutaneous Oxygen Pressure.

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group, phase 4 trial with an enrollment of 60. Participants were assigned to liraglutide or control. The liraglutide group received the drug according to current clinical practice; the control group was monitored closely and received optimization of therapy for major atherosclerosis risk factors. Both groups were followed for six months.

The record contains different descriptions of masking: its design fields label the study single-masked, while the brief summary calls it open-label. It does not explain this difference or state which participants or study personnel, if any, were masked. Details about the randomization procedure, allocation concealment, eligibility criteria beyond the listed conditions, and adherence are not reported in the registry record.

The study conditions are type 2 diabetes and peripheral arterial disease. The primary outcome is transcutaneous oxygen pressure at six months. The brief summary describes the primary objective as a comparison of change between groups at three and six months, while the posted primary outcome measure specifies the lowest pressure recorded after six months and the reported statistical analysis is a comparison of final values. The record does not provide a numerical three-month primary result in the registry record for this analysis.

The registry lists secondary outcomes covering glucose control, weight, body mass index, waist circumference, systolic blood pressure, lipid profile, and C-reactive protein. It records 17 outcome measures and 17 analyses, and 16 secondary outcome measures as posted. The sample-size justification, prespecified statistical analysis plan, intended analysis population, and details of interim analyses are not reported in the registry record. The trial status is completed; the listed start and primary completion dates are 2021-02-01 and 2022-12-31.

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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Peripheral Transcutaneous Oxygen Pressure, measured over 6 months.

Transcutaneous oxygen pressure is a measure of oxygen tension at the skin, used in this trial as an indicator of lower-limb perfusion. The primary endpoint is recorded in mmHg. Its registry description specifies the lowest value recorded on the anterior or posterior tibial artery after six months. The reported group summaries are means with standard deviations, so they describe the average value and the spread of values within each group.

This measure is relevant to the stated research question because the study is concerned with blood supply in the lower limb among people with peripheral artery disease. Comparing the endpoint between randomized groups can describe whether their recorded perfusion measurements differed at the specified follow-up. It does not, by itself, establish why a difference occurred or establish that the measured difference translates into a difference in symptoms, function, or other clinical outcomes.

There is a distinction between the broad wording of the brief summary and the specific posted endpoint: the summary refers to change between groups at three and six months, whereas the primary outcome description identifies the lowest six-month value, and the reported analysis is labelled as a comparison of final values. The registry record does not provide further detail about how these descriptions were reconciled or how a change score was calculated.

7. Results Posted in the Registry

• Liraglutide Group: mean 54.20 versus 43.40 on control; difference 10.80 (95% CI 7.95 to 13.65), standardized effect d = 2.01; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

HbA1c Glucose Control

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Liraglutide Group: mean 6.70 versus 6.80 on control; difference -0.10 (95% CI -0.50 to 0.30), standardized effect d = -0.13; z-test p = 0.621.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liraglutide Group and the control. The interval gives the range of effects that remain compatible with the data.

Weight Change

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Liraglutide Group: mean 78.50 versus 80.70 on control; difference -2.20 (95% CI -9.34 to 4.94), standardized effect d = -0.16; z-test p = 0.546.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liraglutide Group and the control. The interval gives the range of effects that remain compatible with the data.

BMI Change

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Liraglutide Group: mean 28.70 versus 27.70 on control; difference 1.00 (95% CI -1.22 to 3.22), standardized effect d = 0.24; z-test p = 0.378.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liraglutide Group and the control. The interval gives the range of effects that remain compatible with the data.

The registry identifies 16 secondary outcome measures as posted, spanning glucose control and other cardiometabolic measures. Numerical detail is available for a subset of those outcomes. Across the detailed secondary comparisons, estimates do not form a uniformly consistent pattern, and their uncertainty is substantial relative to the estimated contrasts. The registry’s reported p-values for these detailed comparisons do not provide strong evidence against their respective no-difference hypotheses under unadjusted testing.

These results provide context around the primary perfusion finding, but they do not confirm or negate it. Secondary outcomes measure different aspects of health and are not interchangeable with the primary transcutaneous oxygen pressure endpoint. A difference in the primary measure can coexist with unclear or inconclusive results on other measures; conversely, a secondary finding would not independently establish the primary result.

Unadjusted secondary results carry less weight because multiple outcomes create multiple opportunities for chance findings. The registry record does not report a multiplicity correction, a testing hierarchy, or a statistical analysis plan specifying which secondary comparisons were confirmatory. It is therefore not possible to determine whether the reported secondary p-values account for the number of outcomes analyzed. The full set of numerical results for all posted secondary measures is not included in the registry record for this analysis, so a comprehensive direction-of-effect summary across all of them cannot be made.

The most defensible reading is descriptive: the record lists a broad range of secondary measures, and the detailed results do not show a clear, consistent pattern that can be weighed as equivalent to the primary result. Additional claims about the overall secondary profile, especially claims that depend on statistical significance across outcomes, would require analysis-plan and results details not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• HbA1c Glucose Control
• Glucose Control
• Weight Change
• BMI Change
• Waist Circumference Change
• Systolic Blood Pressure Change
• Lipid Profile
• C-reactive Protein (CRP) Change

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean difference represent?

A mean difference subtracts one group’s average from the other group’s average, with the direction depending on which group is named first. For the primary endpoint, the sponsor reports the liraglutide group relative to control and describes the contrast as a mean difference in final values. The units remain mmHg. The mean difference is an estimate of the contrast between the groups, not a measure of the range of individual responses.

The registry also reports the group means and standard deviations. A mean summarizes the central level of a continuous measure, while a standard deviation describes how dispersed individual observations are around that mean. These statistics answer different questions: the standard deviation describes variability among participants, whereas the confidence interval describes uncertainty in the estimated group contrast.

How should the t-test and p-value be read?

The sponsor’s primary analysis is labelled a two-sided t-test of the mean difference in final values. A two-sided test evaluates departures in either direction from a null hypothesis of no mean difference. The p-value is a measure of how surprising data at least as incompatible with that null would be under the test’s assumptions. It is not a measure of the probability that the result is due to chance, nor does it quantify clinical importance.

The simple recalculation uses the posted group means, standard deviations, and group sizes to estimate an unadjusted difference and its uncertainty. It does not reconstruct any individual-level analysis or apply adjustments that might have been used by the sponsor. The recalculation and sponsor analysis are close but not identical; the sponsor’s own reported analysis is the registry’s principal inferential result.

What does randomization contribute?

Random assignment is intended to make the groups comparable on average at the start of a trial, including with respect to factors that may not have been measured. This supports a comparison of outcomes between groups. Randomization does not guarantee that the groups are exactly alike in a particular trial, especially in a modest-sized study, and it does not address losses to follow-up or differences in treatment adherence by itself.

The registry identifies the allocation as randomized but does not describe the sequence-generation method, concealment of assignments, or baseline balance in the registry record. It also gives conflicting masking descriptions: a single-masked design label and an open-label brief summary. No further explanation is reported in the registry record. These omissions make it difficult to assess how assignment and knowledge of treatment may have affected measurement or conduct.

Why does the endpoint definition matter?

The primary measure is a continuous outcome, reported as a mean and standard deviation. The endpoint description focuses on the lowest transcutaneous oxygen pressure recorded at either the anterior or posterior tibial artery after six months. A specific definition makes clear what measurement the analysis concerns, but the registry’s summary also refers to change at three and six months. The reported analysis is labelled as a final-value comparison. The record does not explain whether the lowest-value definition, the change language, or the final-value analysis was used in a more detailed protocol or analysis plan.

Differences in endpoint timing and definition can affect interpretation. A comparison of final values is not necessarily the same estimand as a comparison of changes from baseline. The latter uses information about baseline values; the former compares measured values at follow-up. The record does not report a numerical baseline result or a baseline-adjusted primary estimate, so no such interpretation should be assumed.

What do the secondary analyses add?

The registry lists secondary measures related to glucose control and cardiometabolic risk factors. These may help describe outcomes beyond the primary perfusion measure, but secondary results generally require more caution when many outcomes are assessed. Each additional analysis creates another opportunity for a small p-value to arise by chance, especially when no adjustment for multiple comparisons is specified. The record does not state whether secondary outcomes were prespecified in a hierarchy or whether multiplicity was controlled.

Unadjusted secondary p-values should therefore be read as exploratory evidence rather than as a collection of independent confirmatory tests. The available record gives detailed numerical comparisons for some secondary measures, but it does not supply a full protocol-level account of their status, analysis populations, or adjustment. The reported values alone cannot establish a consistent pattern across every secondary outcome.

What assumptions underlie the summaries?

Mean-based comparisons and t-tests rely on assumptions about the data and sampling process. In general, the interpretation is most straightforward when observations are independent and the sampling distribution of the estimated mean difference is adequately approximated by the test. The registry record does not provide diagnostic checks, transformation details, or a description of how potential outliers were handled. These details are not reported in the registry record.

The sample-size illustrations use a normal approximation, equal allocation between groups, and a two-sided significance level of 0.05, with the effect set to a stated fraction of the observed effect. Those are assumptions for the planning illustrations, not evidence about the original trial design. The original design assumptions and sample-size justification are not reported in the registry record.

For the primary comparison, both the sponsor’s analysis and the unadjusted recalculation report p < 0.001. That agreement in broad direction does not eliminate the need to distinguish the sponsor’s inferential analysis from a calculation based only on aggregate summaries. Nor does it resolve questions about missing outcomes, analysis population, masking, or the endpoint wording. These aspects are important to a complete appraisal but cannot be reconstructed from the posted summary statistics.

11. Confidence Intervals and Precision

A confidence interval gives a range of values that are reasonably compatible with the observed data and the assumptions of the analysis. It communicates the precision of an estimate more directly than a p-value alone. A narrower interval indicates greater precision about the estimated contrast; it does not guarantee that the estimate is free from bias or clinically important.

For the primary endpoint, the sponsor reports a mean difference of 11.2 mmHg and a 95% confidence interval from 8.0 to 14.5. The interval lies above zero, consistent with a positive difference under that analysis. The unadjusted recalculation gives a mean difference of 10.8 mmHg and a 95% confidence interval from 7.952 to 13.65. These intervals are similar but not identical because the sponsor’s analysis and the simple summary-statistic recalculation are not the same calculation.

For the secondary results, the intervals are less conclusive about the direction and size of the contrasts. The registry’s reported intervals for the three detailed secondary comparisons include or approach the value of no difference, and the corresponding p-values are not below 0.05. These intervals should not be read as proof of no effect: they indicate that the data do not precisely distinguish among a range of possible contrasts. A confidence interval also does not account for the added uncertainty associated with multiple outcome testing unless the analysis explicitly adjusts for it.

Precision depends on the amount of information in the data, including the number of participants and the variability of the measurement. The group sizes contributing to the primary summaries are 27 and 28. The registry does not report how missing measurements were handled or whether the reported analysis includes all randomized participants. The confidence intervals therefore describe uncertainty within the reported analysis, not every possible source of uncertainty about the trial.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning illustrations express sample sizes as participants per arm for 80% power and participants per arm for 90% power. They are not total event counts because the primary outcome and the listed secondary outcomes are continuous measures, not time-to-event outcomes. The estimates use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to 100%, 75%, or 50% of the observed effect, as labelled in each planning scenario.

Power is the probability that a planned study would meet its prespecified statistical criterion if the assumed effect and other planning assumptions were correct. The 80% and 90% columns represent two different target probabilities for detecting the assumed effect. A higher target power generally requires more participants under the same assumptions. These figures are planning illustrations based on the observed effect, not observed power and not the trial’s original sample-size justification.

The scenarios make the effect-size assumption explicit. Planning for 75% of the observed effect or 50% of the observed effect means aiming to detect a smaller contrast than the observed estimate. Smaller effects require more participants to distinguish them from random variation with the stated power targets. The resulting numbers are sensitive to the estimated effect used: an unusually large observed effect can produce small illustrative sample sizes, while a smaller assumed effect leads to substantially larger requirements.

The registry record does not report the original sample-size assumptions, justification, or target power for the trial. The illustrations should therefore not be treated as evidence that the study was designed with these sample sizes in mind, or as a retrospective assessment of whether the completed trial was adequately powered.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 10.800; pooled standard deviation σ = 5.368.
2. n = 2 × (1.96 + 0.842)² × 5.368² / 10.800² = 3.9, rounded up to 4 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 10.8                      # observed difference in means
sigma <- 5.36786384553026                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4881110)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 4 (80% power), 6 (90% power)
 75% of observed effect: n per arm = 7 (80% power), 10 (90% power)
 50% of observed effect: n per arm = 16 (80% power), 21 (90% power)
power.t.test: 5 
Simulated power at n = 4 per arm: 0.665 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s reported primary comparison is a two-sided t-test of final values. It gives a mean difference of 11.2 mmHg, a 95% confidence interval from 8.0 to 14.5, and p < 0.001. The simple unadjusted recalculation from the posted group means, standard deviations, and group sizes gives a mean difference of 10.8 mmHg, a 95% confidence interval from 7.952 to 13.65, and p < 0.001.

The two estimates point in the same direction and are close, but they are not identical. The recalculation uses aggregate summaries and is not a reproduction of any individual-level model or additional analysis that may have been performed. The registry does not describe enough detail to identify the source of the small numerical difference. The sponsor’s own analysis is the reported inferential result; the recalculation is a transparent, unadjusted comparison based on the posted summaries.

The same distinction matters for the secondary comparisons. Their sponsor-reported values and aggregate-summary recalculations need not match exactly. Where the registry gives a sponsor analysis, that is the reported analysis; a recalculation should not be presented as replacing it. The record does not describe adjustments or analysis-plan details that would explain every difference across methods.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists numerous outcome measures and analyses, including a primary endpoint and multiple secondary measures. Testing many outcomes increases the chance that at least one result may appear notable even when no corresponding underlying difference exists. Statistical approaches can address this problem through prespecified outcome hierarchies, adjustments to significance thresholds, or other procedures. Whether any such approach was used is not reported in the registry record.

The record also does not report a protocol or detailed statistical analysis plan describing the primary estimand, covariate adjustment, outcome hierarchy, handling of repeated measurements, or rules for missing data. The brief summary refers to primary change at three and six months, while the posted primary measure and sponsor analysis describe a six-month endpoint and a final-value comparison. The record does not explain the relationship between these descriptions.

The registry provides group sizes for the posted primary endpoint summaries but does not state how many participants were randomized to each group, whether every randomized participant was included in the analysis, or why the endpoint group sizes differ from the enrollment figure. Missing outcome data, withdrawals, exclusions, and their reasons are not reported in the registry record. No imputation method or sensitivity analysis for missing data is reported.

The analysis population is also not specified. For example, the record does not say whether the primary analysis followed participants according to randomized assignment regardless of treatment received, or whether it included only participants who completed treatment or follow-up. This information matters because excluding participants or handling missing values in different ways can affect the estimated group contrast.

These omissions do not invalidate the reported results, but they constrain assessment of robustness and risk of bias. The posted confidence intervals and p-values quantify uncertainty under their respective analyses; they do not resolve uncertainty arising from unreported analysis choices, missingness, or multiplicity.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports zero serious adverse events among 27 participants at risk in the liraglutide group and zero among 28 participants at risk in the control group. It also reports zero other adverse events in each group and zero deaths in each group. These are the event counts recorded during the trial, not evidence that the true risk of an event is zero.

When no events are observed, the data provide limited information about how uncommon or common an event might be beyond the trial. The group sizes are small, and the record does not provide confidence intervals for these safety counts, details of event collection, or a list of serious event terms. The absence of listed events should therefore be interpreted as no events recorded in these groups in the registry results, rather than as proof of no risk.

The registry’s adverse-event summary does not describe exposure time by participant, severity grading for non-serious events, or whether all randomized participants contributed safety data. Those details are not reported in the registry record. The figures are descriptive and do not support a definitive comparative safety conclusion.

17. What the Result Does, and Does Not, Mean

The central statistical finding is a higher mean six-month transcutaneous oxygen pressure in the liraglutide group than in the control group in the posted results. The sponsor’s reported mean difference is 11.2 mmHg, with a 95% confidence interval from 8.0 to 14.5 and p < 0.001. The unadjusted recalculation produces a similar estimate and also reports p < 0.001. This describes the observed comparison for the endpoint as defined in the registry.

The result does not, by itself, establish that liraglutide caused the observed difference. Randomization supports a comparative interpretation, but assessment also depends on study conduct, masking, missing outcomes, analysis population, and prespecified methods. Several of those details are not reported in the registry record, and the masking descriptions are inconsistent. The posted endpoint is a measurement of transcutaneous oxygen pressure, not a direct report of symptoms, function, or other patient-important outcomes.

Nor does a small p-value show that the difference is clinically important. The registry does not state a threshold for a clinically meaningful change in this measure. Statistical evidence about a mean contrast and clinical interpretation are related but distinct questions. The confidence interval describes a range of contrasts compatible with the sponsor’s analysis; it does not resolve the clinical meaning of those contrasts.

The secondary findings are less conclusive and should be interpreted in light of the number of outcomes assessed. The registry does not report whether multiplicity was handled, and it does not provide the full set of details needed to assess all secondary results together. The adverse-event summary records no events, but its group sizes and absence of precision estimates limit what can be inferred about safety.

Overall, the registry results describe a clear difference in the primary recorded measurement under the reported analysis, while leaving important questions about clinical relevance, analysis choices, missing data, and broader outcome patterns unresolved. The findings should be understood as trial-specific estimates, not as a complete account of all potential benefits and risks.

18. Why This Trial Matters Statistically

This trial is statistically interesting because its primary comparison combines a continuous physiological endpoint with a randomized group design. The mean difference and confidence interval communicate not only the direction of the observed contrast but also its estimated precision. The sponsor’s result and the aggregate-summary recalculation are similar, illustrating how a straightforward check can help readers understand posted summary data while remaining distinct from the sponsor’s analysis.

The trial also illustrates why endpoint wording and analysis method deserve close attention. The brief summary describes change at three and six months, but the posted primary endpoint specifies the lowest six-month measurement and the sponsor analysis is described as a comparison of final values. Those formulations may refer to different estimands. Without a protocol or detailed analysis plan in the registry record, the relationship cannot be resolved.

Multiplicity is another important statistical issue. A trial can report many secondary measures, and interpreting each p-value in isolation can overstate the strength of evidence. The record’s list of secondary outcomes makes clear that the primary endpoint should be distinguished from exploratory or supportive results, particularly when a correction or hierarchy is not reported.

Finally, the record demonstrates the difference between a planning illustration and the original design justification. Sample-size calculations based on fractions of an observed effect can help explain how assumptions about effect size relate to required sample size. They cannot establish what assumptions guided the trial, because those original design details are not reported in the registry record. Keeping these distinctions clear helps prevent overinterpretation of both significant and non-significant findings.

19. 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 trial-specific reporting gaps limit interpretation. The registry’s design fields describe the study as single-masked, while the brief summary calls it open-label. The record does not explain the discrepancy or identify who was masked. This leaves uncertainty about possible influences on treatment delivery, outcome assessment, or participant behavior.

The primary endpoint descriptions also differ in emphasis. The brief summary refers to change at three and six months, whereas the outcome record specifies the lowest six-month transcutaneous oxygen pressure and the reported analysis compares final values. The available information does not include a numerical three-month result, baseline-adjusted primary estimate, or explanation of how change and final-value analyses relate.

The registry lists enrollment of 60, while the primary endpoint summaries include 27 and 28 participants. It does not state why these counts differ, how many participants were randomized, whether these are all participants with endpoint data, or how any missing outcomes were handled. Without those details, attrition and the analysis population cannot be assessed.

The registry does not report the original sample-size justification, prespecified statistical analysis plan, multiplicity strategy, randomization procedure, allocation concealment, or interim analyses. It also does not provide enough detail to assess adherence, treatment exposure, or whether the primary analysis adjusted for baseline measurements. These are not necessarily flaws in trial conduct; they are information gaps in the record.

Finally, the available secondary results cover only part of the 16 posted secondary outcomes, and the adverse-event summary provides event counts without uncertainty estimates or detailed ascertainment information. The findings therefore offer a limited view of secondary patterns and safety, in addition to the primary endpoint comparison.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Liraglutide and Peripheral Artery Disease — NCT04881110.
• Registry record last updated 2025-03-03; status last verified 2025-02.
• Results first posted 2025-03-03.
• 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.

23. Record Summary

The registry record describes a completed randomized, parallel-group, phase 4 trial of liraglutide versus close monitoring and optimization of atherosclerosis risk-factor therapy in people with type 2 diabetes and peripheral artery disease. Enrollment was 60, with six-month follow-up. The primary outcome was transcutaneous oxygen pressure in mmHg.

At six months, the sponsor reported a mean difference in final values of 11.2 mmHg, with a 95% confidence interval from 8.0 to 14.5 and p < 0.001. The unadjusted recalculation from group summaries was 10.8 mmHg, with a 95% confidence interval from 7.952 to 13.65 and p < 0.001. The registry also lists secondary outcomes and reports zero serious adverse events, zero other adverse events, and zero deaths in both groups.

Important details—including the original sample-size justification, analysis population, missing-data handling, multiplicity approach, and explanation of conflicting masking and endpoint descriptions—are not reported in the registry record.