Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes (NCT02777073), a randomized na study. The primary outcome is Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin.

2. Clinical Question

The question is narrow in both duration and outcome: it concerns short-term changes after a single dose, not longer-term metabolic effects or clinical outcomes. The registry lists additional exploratory metabolic measures, including glucagon, free fatty acids, and ghrelin. Results for those measures can provide context about the recorded short-term responses, but they do not replace the primary ketone outcome or establish effects beyond the measured timeframe.

3. Trial Design

NCT02777073, titled “Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes,” is listed as a completed randomized trial. It used a parallel-group model and single masking. The record does not identify who was masked or describe how randomization was generated or implemented. Phase is listed as NA.

The registry lists 43 participants enrolled. The reported primary-outcome groups comprise 13 participants assigned to liraglutide 1.8 mg, 13 assigned to placebo, and 17 assigned to dapagliflozin. Each intervention was a single dose. The outcome timeframe was 8 hours, so the reported comparison concerns an acute measurement period rather than sustained exposure or follow-up over a longer period.

The listed primary outcome is the difference in beta-hydroxybutyrate formation after a single dose, measured in mM and summarized as a mean with standard error. Its description specifies plasma beta-hydroxybutyrate. Three secondary outcomes are posted: change in glucagon, change in free fatty acid concentrations, and change in ghrelin concentrations. They are also reported over 8 hours, with the ghrelin timeframe capitalized as “8 Hours” in its registry entry.

The registry lists the University at Buffalo as sponsor and gives the study start as 2016-03-01 and primary completion as 2016-12-01. The record’s status is completed. It does not describe allocation concealment, masking procedures, protocol deviations, participant flow by analysis population, or the original statistical analysis plan. Those design details 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.

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 Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin, measured over 8 hours.

The primary endpoint measures plasma beta-hydroxybutyrate, a ketone body, after a single dose of liraglutide, dapagliflozin, or placebo. The registry states an 8-hour timeframe and reports the outcome in mM as a group mean with its standard error. The listed endpoint title refers to ketone-body formation, while its description specifically names beta-hydroxybutyrate in plasma.

Ketone measurements are used in this study to characterize ketogenesis, the production of ketone bodies, during the short period after dosing. The registry summary also discusses beta-hydroxybutyrate and acetoacetate in plasma and urine, but the posted primary endpoint is narrower: it concerns plasma beta-hydroxybutyrate. The registry does not state a separate primary endpoint for acetoacetate or urine ketones.

A group mean gives the average observed measurement within an arm, while the standard error describes the uncertainty around that estimated mean. Neither quantity by itself describes the spread of individual participants’ measurements. The endpoint can therefore be read as a comparison of average short-term plasma beta-hydroxybutyrate levels, with uncertainty, rather than as a measure of every participant’s response or of longer-term clinical outcomes.

The registry record does not report why this endpoint was selected, a threshold for clinical importance, or a hypothesis about the size of a meaningful difference. The outcome is relevant to the stated study question about ketogenesis, but its clinical interpretation requires keeping the limited time window and laboratory measurement in view.

7. Results Posted in the Registry

• Liraglutide 1.8 mg: mean 0.08 versus 0.25 on control; difference -0.17 (95% CI -0.31 to -0.03), standardized effect d = -0.94; z-test p = 0.016.
• Dapagliflozin: mean 0.21 versus 0.25 on control; difference -0.04 (95% CI -0.18 to 0.10), standardized effect d = -0.20; z-test p = 0.572.

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.

Change in Glucagon Levels.

• 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 errors.
• Result:
  • Liraglutide 1.8 mg: mean -19.00 versus 1.00 on control; difference -20.00 (95% CI -49.85 to 9.85), standardized effect d = -0.52; z-test p = 0.189.
  • Dapagliflozin: mean -15.00 versus 1.00 on control; difference -16.00 (95% CI -31.31 to -0.69), standardized effect d = -0.76; z-test p = 0.041.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liraglutide 1.8 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Dapagliflozin than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Free Fatty Acid (FFA) Concentrations

• 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 errors.
• Result:
  • Liraglutide 1.8 mg: mean 0.10 versus 0.17 on control; difference -0.07 (95% CI -0.24 to 0.10), standardized effect d = -0.32; z-test p = 0.409.
  • Dapagliflozin: mean 0.11 versus 0.17 on control; difference -0.06 (95% CI -0.23 to 0.11), standardized effect d = -0.26; z-test p = 0.480.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liraglutide 1.8 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Dapagliflozin and the control. The interval gives the range of effects that remain compatible with the data.

Change in Ghrelin Concentrations

• 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 errors.
• Result:
  • Liraglutide 1.8 mg: mean -32.00 versus 66.00 on control; difference -98.00 (95% CI -177.01 to -18.99), standardized effect d = -0.95; z-test p = 0.015.
  • Dapagliflozin: mean 32.00 versus 66.00 on control; difference -34.00 (95% CI -110.34 to 42.34), standardized effect d = -0.32; z-test p = 0.383.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Liraglutide 1.8 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Dapagliflozin and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes add short-term measurements of glucagon, free fatty acids, and ghrelin to the ketone endpoint. Collectively, they do not form a consistent pattern in which every measure changes in the same direction or with similar precision across both active-treatment comparisons. Some recalculated comparisons are more compatible with a difference from placebo than others, and the uncertainty varies across measures.

These secondary outcomes provide context for the metabolic response measured during the 8-hour period, but they do not directly answer the primary question about plasma beta-hydroxybutyrate. A secondary change in a related measure cannot be assumed to explain, cause, or confirm the primary result. The study summary also mentions other markers, but the registry’s posted secondary outcomes are glucagon, free fatty acids, and ghrelin; the summary’s mention of additional markers is not accompanied by posted outcome results.

Unadjusted secondary results carry less weight because several outcomes and treatment comparisons create multiple opportunities for apparently notable findings. Without a reported plan addressing multiplicity, the chance of a false-positive result across the set cannot be assessed from the registry record. The registry does not report whether these outcomes were prespecified, whether the comparisons were adjusted, or what hierarchy governed interpretation. As a result, the secondary results are best regarded as exploratory context rather than independent confirmation of the primary finding.

The secondary outcomes are also limited by the short measurement timeframe, modest group sizes, and absence of reported analysis details. The record gives group summaries and recalculated comparisons, but no sponsor-reported analyses. The broader pattern is therefore useful for identifying measurements that may merit further study, not for making a definitive claim about a coherent biological mechanism or a lasting treatment effect.

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

• Change in Glucagon Levels.
• Change in Free Fatty Acid (FFA) Concentrations
• Change in Ghrelin Concentrations

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: beta-hydroxybutyrate is measured on a numeric scale in mM. For a continuous outcome, a group mean describes the average measurement among participants in that arm. The registry also reports a standard error for each mean. Standard error reflects uncertainty in estimating the group mean; it is not the standard deviation of individual measurements and should not be read as a range containing most participants.

What does a mean difference express?

A mean difference compares the average value in one group with the average value in the reference group. The recalculated primary comparisons use placebo as the reference. A negative difference means the intervention-group mean is lower than the placebo mean on the reported scale. For liraglutide, the recalculated mean difference is -0.17 mM; for dapagliflozin, it is -0.04 mM. These contrasts do not compare the two active-treatment groups directly.

The comparisons are simple unadjusted recalculations from the posted group summaries. They are not identified as sponsor analyses, and the registry reports no formal analyses. The record does not specify a statistical model, covariate adjustment, treatment of repeated measurements, or a method for handling missing outcome observations. No additional assumptions about those procedures should be inferred from the recalculated contrasts.

How should a confidence interval be read?

A confidence interval expresses uncertainty around an estimate using a method with a stated long-run coverage property. It is not a range of individual participant values, and it does not assign a probability that the true effect lies in the particular interval after the data have been observed. For a mean difference, an interval that crosses zero is compatible with no difference under the calculation; an interval that excludes zero is less compatible with that null value. Interval width is also informative: wider intervals indicate less precision.

The recalculated primary interval for liraglutide excludes zero, while the interval for dapagliflozin includes zero. This distinction is consistent with their reported unadjusted p-values, 0.016 and 0.572, respectively. The p-value measures how unusual results at least as incompatible with a null comparison would be under the calculation’s null model; it is not the probability that the null hypothesis is true, nor a measure of clinical importance.

Why does uncertainty matter with small groups?

Each primary comparison uses a limited number of participants: the posted arm sizes are 13 for liraglutide, 13 for placebo, and 17 for dapagliflozin. With limited observations, estimates can be sensitive to individual values and uncertainty may remain substantial. A difference in statistical evidence between comparisons is not itself proof that the treatments differ from one another. That would require a direct comparison designed and analyzed for that question.

Standard errors and confidence intervals help communicate this uncertainty. The standard error is reported for the arm means, while the recalculated intervals concern differences between means. Those are different quantities. The interval around a difference incorporates uncertainty from both groups, rather than describing uncertainty in only one arm.

What do the planning figures represent?

The planning illustrations use observed effects from the posted summaries as inputs, with the assumptions stated alongside those illustrations: a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is a stated fraction of the observed effect. These are hypothetical planning scenarios, not the trial’s original sample-size justification. That justification and the trial’s own design assumptions are not reported in the registry record.

The illustrations show how a target effect and desired power relate to the number of participants per arm under those assumptions. They do not show the probability that the completed trial detected an effect, and they do not revise the observed results. Results can be statistically uncertain even when an observed estimate is used as an input for a planning exercise. Since observed effects in small trials may be unstable, planning based directly on them should be interpreted cautiously.

More broadly, statistical significance is only one part of interpretation. The magnitude and direction of the estimated difference, its precision, the measurement timeframe, the endpoint’s clinical relevance, and the analysis plan all matter. The registry record does not report a clinical threshold for beta-hydroxybutyrate, a full analysis plan, or sponsor-reported inferential results. The recalculations should therefore be understood as descriptive statistical context rather than a substitute for those missing details.

11. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an estimated group difference. The standard errors for the primary group means are 0.05 mM in all three arms. The recalculated comparison intervals add information about uncertainty in the difference between an intervention group and placebo. The interval for the liraglutide comparison excludes zero; the interval for the dapagliflozin comparison includes zero. This describes the relation of each estimate to the no-difference value, not the likely range of individual participant measurements.

The liraglutide estimate is -0.17 mM, with p = 0.016. Its interval is on the negative side of zero, but the registry provides no threshold for deciding whether a difference of this size is clinically important. Statistical evidence against a zero difference does not on its own establish importance, durability, or relevance to patient outcomes.

The dapagliflozin estimate is -0.04 mM, with p = 0.572. Its interval spans both negative and positive values. The posted data therefore leave uncertainty about the direction and size of the difference from placebo. This does not demonstrate that the groups are equivalent; equivalence would require an appropriate margin and analysis, neither of which is reported in the registry record.

The interval widths should be considered alongside the small arm sizes and the single 8-hour timeframe. A single short-term endpoint cannot establish how measurements might change later. The registry does not report participant-level distributions, missing-data handling, or sponsor-reported confidence intervals. The intervals discussed are simple unadjusted recalculations from the posted summaries, so they should not be mistaken for intervals from an undocumented adjusted model.

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 figures are participants per arm for 80% power and participants per arm for 90% power. They are not total event counts: the sample-size assumptions explicitly describe participant counts per arm for these continuous-outcome comparisons. The illustrations assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each scenario targets a stated fraction of the observed effect.

Power is the chance that a specified analysis would meet its statistical decision threshold if the assumed effect were the true effect and the planning assumptions held. The 80% column represents planning for an 80% chance of detecting that target effect; the 90% column represents planning for a higher chance. These figures are planning illustrations, not observed power.

For the primary liraglutide-versus-placebo comparison, planning for 100% of the observed effect gives 18 participants per arm for 80% power and 24 participants per arm for 90% power. Planning for 75% of the observed effect gives 32 and 43 participants per arm, respectively; planning for 50% gives 71 and 95. For dapagliflozin versus placebo, the corresponding figures are 375 and 502 for the full observed effect, 667 and 893 for 75%, and 1,500 and 2,008 for 50%.

The pattern illustrates that smaller target effects need more participants to detect under the same assumptions. The values are based on observed effects and are not the trial’s original design justification. The original sample-size assumptions and justification are not reported in the registry record.

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 = -0.170; pooled standard deviation σ = 0.180.
2. n = 2 × (1.96 + 0.842)² × 0.180² / -0.170² = 17.7, rounded up to 18 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 <- -0.17                      # observed difference in means
sigma <- 0.180277563773199                     # 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(2777073)
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 = 18 (80% power), 24 (90% power)
 75% of observed effect: n per arm = 32 (80% power), 43 (90% power)
 50% of observed effect: n per arm = 71 (80% power), 95 (90% power)
power.t.test: 18.7 
Simulated power at n = 18 per arm: 0.785 (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. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and three secondary outcomes, with comparisons of each active-treatment group against placebo. Multiple outcomes and contrasts raise the possibility of multiplicity: when many hypotheses are tested, some results may appear statistically notable by chance even if no underlying differences exist. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a prespecified strategy for interpreting secondary outcomes. The recalculated p-values are unadjusted and should be read accordingly.

The registry reports no formal analysis entries. It does not describe the statistical model, whether measurements were analyzed as change scores or with another approach, how repeated observations within the 8-hour period were handled, or whether any covariates were included. Although the posted outcomes are expressed as changes for the secondary measures, the analysis procedure used to produce them is not reported in the registry record.

Missing-data methods and analysis populations are also not described. The registry does not say how many participants completed each outcome assessment, whether all randomized participants were included in each analysis, or how missing values were handled. The posted outcome group sizes are available, but they do not establish the analysis population definition or confirm that no outcome data were missing.

These absences limit assessment of the protection against false-positive findings and the robustness of the estimates. They also make it difficult to determine whether the simple recalculations align with the trial’s intended analysis. The record does not report an original statistical analysis plan, interim analyses, or a sample-size justification. None should be inferred from the posted summary statistics or the planning illustrations.

Because the reported comparisons are simple unadjusted recalculations and the record contains no sponsor-reported inferential analyses, they offer a transparent but limited reading of the available summaries. A full assessment would require the analysis plan, participant flow, missing-data information, and prespecified approach to multiple outcomes; these are not reported in the registry record.

15. 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 5% reporting threshold.

The registry lists serious adverse event counts for the liraglutide, dapagliflozin, and placebo groups. The numbers at risk are 13, 17, and 13, respectively. The serious adverse event count is 0 in each group, and deaths are listed as 0 in each group. Other adverse events are also listed as affecting 0 participants in each group.

These figures mean that no serious adverse events, deaths, or other adverse events are recorded in the posted group summaries. They should not be read as proof that no adverse events occurred beyond the categories and reporting represented in the registry, or that the treatments have no safety risks. The record does not provide event descriptions, severity details beyond the serious-event category, or additional information about how adverse events were collected.

The groups are small and the outcome period for the main study question is short. Consequently, zero recorded events in these groups cannot establish the absence of uncommon events or characterize safety over longer exposure. The safety figures describe what the registry reports for this trial; they do not support broader safety conclusions.

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

The central result is a difference in short-term average plasma beta-hydroxybutyrate between the liraglutide and placebo groups in the simple unadjusted recalculation. The estimated mean difference is -0.17 mM, and the recalculated p-value is 0.016. The interval excludes zero. For dapagliflozin compared with placebo, the estimated mean difference is -0.04 mM, the p-value is 0.572, and the interval includes zero. These results describe the posted measurements during the 8-hour timeframe.

They do not establish that either treatment has a lasting effect. The trial evaluated single doses and the posted primary endpoint is short-term. It did not report long-term outcomes, clinical events, or an assessment of whether the measured differences correspond to a clinically meaningful threshold. The registry record does not provide such a threshold.

The results also do not establish equivalence between dapagliflozin and placebo or between the two active treatments. An interval that includes zero reflects uncertainty about the comparison; it is not evidence that two groups are the same. Moreover, the primary comparisons are each against placebo, not a direct liraglutide-versus-dapagliflozin test.

The posted summaries do not reveal how individual participants responded, whether responses varied by participant characteristics, or whether the observed group differences would be reproduced in a larger study. The secondary outcomes do not resolve these questions, particularly because their multiplicity strategy and sponsor analyses are not reported.

Accordingly, the registry supports a limited statistical description: the group mean for plasma beta-hydroxybutyrate was lower in the liraglutide arm than in placebo over the recorded period, while the dapagliflozin comparison was uncertain. These findings should not be converted into medical advice or a claim about treatment effectiveness. They concern a small, short-term trial and a laboratory endpoint, with important analysis and design details not reported in the registry record.

17. Why This Trial Matters Statistically

This trial illustrates how a study can have a clearly designated laboratory endpoint while still leaving important interpretive questions open. It reports means and standard errors for three randomized groups, allowing the observed primary outcome to be described. The contrast between the recalculated liraglutide and dapagliflozin comparisons also demonstrates why estimates, intervals, and p-values should be considered together rather than relying on a single threshold.

The difference between a lower point estimate and persuasive statistical evidence is important. The liraglutide comparison’s interval excludes zero, whereas the dapagliflozin comparison’s interval includes zero. That does not show that the treatments differ from each other; each was compared separately with placebo. A direct comparison would be needed to answer that separate question.

The record also highlights the role of uncertainty and study size in planning. The planning illustrations show that targeting a smaller effect requires more participants under the stated assumptions. Because these scenarios use observed effects, they are planning aids rather than evidence about the completed trial’s power or its original design rationale.

Finally, the secondary measures and safety summaries demonstrate the importance of prespecification, multiplicity control, complete reporting, and analysis-population definitions. Without those details, readers can describe the posted outcomes but cannot fully assess how the study’s statistical decisions were made. The trial is therefore instructive both for what its short-term group summaries show and for what registry reporting must include to support stronger interpretation.

18. 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.

The main limitation is scope. The intervention was a single dose, and the primary endpoint timeframe was 8 hours. The registry does not provide evidence about longer-term changes, repeated dosing, or clinical outcomes. The primary measure is a laboratory endpoint, and no clinical-importance threshold is reported.

The total enrollment was 43, with primary-outcome arm sizes of 13, 13, and 17. Such group sizes limit precision and the ability to characterize variation among participants. The registry does not report participant-level data, subgroup analyses, or a detailed account of who contributed measurements to each outcome.

Important methods are absent from the registry record. It does not describe how randomization was generated, who was masked, how missing data were handled, which analysis populations were used, or the statistical model for outcomes. The original sample-size justification, interim analyses, and multiplicity strategy are also not reported. The registry lists no formal analysis entries, so the recalculated comparisons are not a substitute for sponsor-reported analyses.

The endpoint description focuses on plasma beta-hydroxybutyrate, while the broader study summary refers to ketone bodies in plasma and urine. The posted primary result does not provide an outcome for acetoacetate or urine ketones. The scope of inference should therefore stay with the measured primary outcome rather than extend to all ketone measures mentioned in the study summary.

Finally, the secondary outcomes involve multiple measures and comparisons. Without a stated correction strategy or analysis hierarchy, nominal unadjusted findings should be interpreted cautiously. These limitations do not erase the descriptive information in the registry, but they constrain claims about precision, clinical relevance, and reproducibility.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes — NCT02777073.
• Registry record last updated 2024-02-29; status last verified 2024-02.
• Results first posted 2024-02-29.
• 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.

22. Record Summary

NCT02777073 is a completed, randomized, single-masked, parallel-group trial sponsored by the University at Buffalo. It enrolled 43 participants and compared single doses of liraglutide 1.8 mg and dapagliflozin 10 mg with placebo in type 1 diabetes. The listed primary endpoint was plasma beta-hydroxybutyrate over 8 hours, reported as a mean and standard error.

The posted primary group means were 0.08 mM for liraglutide, 0.25 mM for placebo, and 0.21 mM for dapagliflozin. Simple unadjusted recalculations show a mean difference of -0.17 mM for liraglutide versus placebo and -0.04 mM for dapagliflozin versus placebo. The registry also lists secondary outcomes for glucagon, free fatty acids, and ghrelin, with no serious adverse events or deaths recorded in the group summaries.

The results describe short-term group measurements. Sponsor-reported analyses, a full statistical plan, missing-data methods, and the original sample-size justification are not reported in the registry record.