Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion (NCT02113241), a randomized phase 2, phase 3 study. The primary outcome is Waist Circumference at Week 12..

2. Clinical Question

The clinical question is a comparison between randomized groups, not a test of whether waist circumference changed within either arm considered alone. A treatment contrast estimates how the groups differed at the stated endpoint; it does not by itself establish why that difference occurred or whether it is important to patients. The registry record does not report a clinical threshold for a meaningful waist-circumference change, so the estimate must be read alongside its uncertainty rather than judged against an unreported threshold.

3. Trial Design

This completed study is registered as Phase 2 and Phase 3, with randomized allocation, double masking, and a parallel-group model. The sponsor is the University of Guadalajara. The registry record gives a start of 2014-04 and primary completion of 2015-05. Its enrollment is 24, and the condition is listed as metabolic syndrome X.

Participants were assigned to dapagliflozin or placebo. Each arm description specifies a capsule, 10 mg, taken once per day before breakfast during 90 days. The double-masked design is intended to keep treatment assignment unknown to participants and relevant study personnel, while random allocation aims to make the groups comparable on average. The registry record does not report the exact allocation procedure, how masking was maintained, or whether masking was assessed.

The primary outcome was mean waist circumference at Week 12, measured in centimeters. The primary endpoint description says measurement used a flexible tape with standardized techniques. The registry identifies the intended analysis population as all participants, including those who dropped out before the end, under an intention-to-treat approach. It does not report the detailed method used to incorporate missing endpoint measurements or whether every randomized participant contributed a Week 12 value.

The registry lists several secondary measures, including body size and composition, cholesterol, liver enzymes, and creatinine. The original sample-size justification, a prespecified statistical analysis plan, and details of interim analyses are not reported in the registry record. The primary outcome summaries list 12 participants in the dapagliflozin arm and 11 in the placebo arm; the record does not explain the difference between those listed outcome counts and the enrollment figure.

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

Analysis population for the primary outcome, as defined in the registry: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

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 Waist Circumference at Week 12., measured over Week 12.

Waist circumference is a continuous measure of abdominal size, recorded in centimeters. The registry specifies assessment at Week 12 with a flexible tape and standardized techniques. The primary endpoint is the mean waist circumference in each randomized group at that time point, with the principal comparison being the difference between those group means.

In general, a continuous endpoint preserves information across the range of measured values rather than classifying participants into broad categories. Comparing group means can therefore describe the average separation between the assigned groups. The standard deviation describes how spread out individual measurements are within a group; it is not the uncertainty in the estimated group mean or in the between-group difference.

Waist circumference is used in this study as a measure related to the broader metabolic-syndrome research question. It is not itself a direct measurement of insulin sensitivity or insulin secretion. Although the registry’s study aim refers to metabolic syndrome, insulin sensitivity, and insulin secretion, the primary endpoint listed in the results is waist circumference at Week 12. The registry record does not report a threshold defining a clinically important difference in this measure, or a method for translating a difference in centimeters into a broader clinical conclusion.

7. Results Posted in the Registry

• Dapagliflozin: mean 97.60 versus 97.20 on control; difference 0.40 (95% CI -6.08 to 6.88), standardized effect d = 0.05; z-test p = 0.904.

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.

Body Weight at Week 12.

• 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:
  • Dapagliflozin: mean 81.20 versus 79.60 on control; difference 1.60 (95% CI -8.25 to 11.45), standardized effect d = 0.13; z-test p = 0.750.
• Interpretation:
  • 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.

Body Mass Index at Week 12

• 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:
  • Dapagliflozin: mean 32.60 versus 32.10 on control; difference 0.50 (95% CI -2.09 to 3.09), standardized effect d = 0.16; z-test p = 0.705.
• Interpretation:
  • 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.

Fat Mass at Week 12.

• 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:
  • Dapagliflozin: mean 32.70 versus 34.40 on control; difference -1.70 (95% CI -8.46 to 5.06), standardized effect d = -0.20; z-test p = 0.622.
• Interpretation:
  • 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 registry lists secondary measures spanning body weight, body mass index, fat mass, cholesterol measures, liver enzymes, and creatinine. The posted record identifies 15 secondary outcome results, while full numerical details are not available for every listed measure in the information reported. The available continuous summaries cover body weight, body mass index, and fat mass at Week 12. Their recalculated between-group intervals all include zero, and their point estimates do not move in the same direction across these measures.

Taken together, the available secondary summaries do not provide a consistent pattern of separation across body-size and composition measures. Nor do these endpoints independently settle the primary waist-circumference question: each measures a different feature, and the primary comparison remains the prespecified waist-circumference endpoint. The registry record does not report a single combined secondary outcome or a hierarchy that would make one secondary measure confirmatory.

Unadjusted secondary analyses carry less weight because multiple outcomes create multiple opportunities for apparently notable results, even when no true differences exist. In general, multiplicity-aware planning and interpretation help control that risk. The registry record does not report a multiplicity adjustment or a prespecified strategy for interpreting secondary endpoints. The reported group-specific Wilcoxon p-values also should not be treated as direct treatment comparisons. Secondary findings are best viewed as exploratory context, not as a substitute for a clear, precise primary contrast.

Because the secondary record is incomplete in the information reported, it is not possible to characterize all 15 results or determine whether their analysis and reporting were prespecified. The overall pattern should therefore be described cautiously: the available summaries do not establish a coherent secondary signal, and the absence of a reported adjustment makes isolated findings less persuasive.

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

• Body Weight at Week 12.
• Body Mass Index at Week 12
• Fat Mass at Week 12.
• Total Cholesterol at Week 12
• Low Density Lipoproteins (c-LDL) at Week 12
• Alanine Aminotransferase (ALT) at Week 12.
• Aspartate Aminotransferase (AST) at Week 12.
• Creatinine at Week 12.

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, and the posted arm summaries give a mean and standard deviation for each group. The recalculated comparison uses the difference between those means, with the direction defined as dapagliflozin minus placebo. This is an unadjusted summary contrast: it does not account for baseline values or other covariates. The registry record does not report an adjusted primary estimate.

What does a mean difference describe?

In general, a mean difference expresses the average separation between two groups on the original measurement scale. Here, that scale is centimeters. A positive estimate means the dapagliflozin group’s reported mean is higher than the placebo group’s mean; a negative estimate would mean it is lower. This direction is a description of the arithmetic contrast, not a judgment about benefit or harm. The estimated difference is 0.4 centimeters.

The standard deviations reported for the arms describe the spread of individual waist measurements within each group. They are not confidence limits for the means. A confidence interval for a contrast incorporates both the observed variability and the amount of information available. It gives a range of estimates compatible with the data under the calculation’s assumptions. The recalculated interval is -6.079 to 6.879 centimeters.

How should the p-value be read?

In general, a p-value describes how incompatible the observed data are with a specified null model, assuming that model and the analysis assumptions hold. It is not the probability that the null hypothesis is true, the probability that chance alone caused the result, or a measure of effect size. The primary recalculation’s unadjusted p-value is 0.904. That value does not provide evidence of a clear difference under the calculation, but it does not establish equivalence or prove no effect.

The registry separately reports Wilcoxon (Mann-Whitney) analyses for each arm. This rank-based method compares distributions through the ordering of observations rather than directly estimating a difference in arithmetic means. The record gives p-values for those arm-specific entries but does not state a contrast estimate or confidence interval from that method. As a result, those entries cannot substitute for a direct randomized-group comparison. The record does not explain the precise null hypothesis used for those entries.

What does unadjusted mean in this comparison?

An unadjusted calculation compares the posted group summaries without incorporating other variables. In general, covariate adjustment can be useful when prespecified and appropriately modeled, but it can also change the estimate and its uncertainty. The original statistical plan, any adjustment variables, and the sponsor’s detailed primary comparison are not reported in the registry record. The recalculation is therefore best understood as a transparent summary-based contrast, not as a replacement for a fully documented trial analysis.

Randomization supports a between-group interpretation because assignment, if implemented as intended, is designed to reduce systematic differences at baseline. However, the registry record does not provide baseline outcome summaries, details of allocation concealment, or the full analysis population flow. It also does not detail missing-data methods. Those omissions limit assessment of whether the posted endpoint summaries fully preserve the intended randomized comparison.

Why can over-dispersion matter in general?

In general, over-dispersion means that the observed variability is greater than a model assumes. It can make standard errors too small if a model fails to account for the extra variability, leading to intervals that are too narrow and tests that appear more decisive than warranted. This primary endpoint is continuous and the recalculation uses posted means and standard deviations; the registry record does not report an over-dispersion assessment or a model-based adjustment. The concept is relevant broadly, but there is no basis in the record to claim that over-dispersion occurred in this analysis.

The reported summary data support a simple unadjusted mean comparison, but they do not reveal all analytic choices behind the sponsor’s own work. The discrepancy flag is important: the sponsor’s own analysis takes precedence over the recalculation. The recalculation remains useful for reading the group means and approximate contrast from the posted summaries, while the record’s limited detail means that the exact reason for differing results is not reported in the registry record.

11. Confidence Intervals and Precision

The recalculated mean difference in waist circumference is 0.4 centimeters, with a confidence interval from -6.079 to 6.879 centimeters. The interval is the key precision measure: it spans estimates on both sides of zero and is broad relative to the point estimate. It therefore leaves considerable uncertainty about the direction and size of the between-group difference.

In general, a confidence interval reflects sampling uncertainty under the calculation’s assumptions. It is not a range containing every participant’s measurement, and it does not guarantee that the true effect lies within its limits. The confidence level used for this recalculated interval is not reported in the registry record, so no confidence percentage should be inferred from the record.

The arm standard deviations are 8.9 centimeters for dapagliflozin and 6.9 centimeters for placebo. These describe within-arm variation, not the precision of the contrast by themselves. Precision depends on variability and the amount of information available. The primary outcome summaries list 12 participants for dapagliflozin and 11 for placebo, and the broad interval is consistent with caution about how much the estimate can resolve.

The interval’s inclusion of zero is not evidence that the two treatments are equivalent. A formal equivalence or non-inferiority conclusion would require an appropriate design, a specified margin, and a corresponding analysis; these are not reported in the registry record. The interval likewise does not show that any difference within its limits is clinically important. No clinical-importance threshold is reported.

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 sample-size figures are planning illustrations based on the observed effect, not a report of the trial’s original design calculations. For this continuous outcome, the figures are participants per arm, not total events. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The original trial’s sample-size assumptions and justification are not reported in the registry record.

The 80% power column means the planned design would have an 80% probability of detecting the chosen effect under the stated assumptions, if that effect and assumptions were correct. The 90% power column uses a higher target probability of detection. In both cases, the calculation is prospective planning, not a description of what the completed trial achieved. This is not observed power.

The rows use 100%, 75%, and 50% of the observed effect as planning targets. A smaller target effect is harder to distinguish from random variation, so it requires more participants per arm to reach the same target power. The figures should be read as illustrations of how strongly the required enrollment depends on the effect size assumed, rather than as a claim that any particular future design is adequate. The very large requirements arise because the observed primary mean difference is small in relation to its uncertainty; they should not be interpreted as evidence that the trial was designed to detect those effects.

These calculations do not account for any unreported design features, outcome attrition, covariate adjustment, or multiplicity. Their usefulness is conceptual: they show that planning around an estimated effect from a small study can produce unstable and very large requirements. A future design would need its own justified target effect and analysis assumptions.

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 = 0.400; pooled standard deviation σ = 8.010.
2. n = 2 × (1.96 + 0.842)² × 8.010² / 0.400² = 6,295.0, rounded up to 6,296 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 <- 0.399999999999991                      # observed difference in means
sigma <- 8.01014238028145                     # 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(2113241)
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 = 6,296 (80% power), 8,428 (90% power)
 75% of observed effect: n per arm = 11,192 (80% power), 14,982 (90% power)
 50% of observed effect: n per arm = 25,181 (80% power), 33,710 (90% power)
power.t.test: 6296 
Simulated power at n = 6,296 per arm: 0.797 (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 registry’s reported analyses use the Wilcoxon (Mann-Whitney) method and list p-values separately for the dapagliflozin and placebo arms: <0.001 and 0.089, respectively. The record does not provide an accompanying estimate or confidence interval for a direct between-arm contrast from these entries. Separate arm-specific p-values do not test whether the randomized groups differ from one another; a contrast between the groups is needed to answer that question.

The posted mean summaries allow an unadjusted recalculation of the difference in Week 12 waist circumference, with an estimate of 0.4 centimeters, a confidence interval from -6.079 to 6.879 centimeters, and an unadjusted p-value of 0.904. The registry indicates a discrepancy between the sponsor’s analyses and this recalculation. Under that circumstance, the sponsor’s own analysis takes precedence. The recalculation is still informative as a check based on the posted means and standard deviations, but it is not the sponsor’s full analysis.

The record does not report enough detail to explain why the results differ, including the exact question tested in the arm-specific analyses, the analysis population used for each, or any adjustments. The sponsor’s entries should therefore be reported faithfully without interpreting them as evidence of a treatment-versus-placebo effect. The direct comparative estimate and its uncertainty remain important for understanding the posted group summaries.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when researchers examine several endpoints, time points, subgroups, or statistical contrasts. In general, the more analyses conducted, the greater the chance that at least one result may look unusual by chance. A prespecified outcome hierarchy, adjustment procedure, or other multiplicity strategy can clarify how to interpret a collection of tests. Such a strategy is not reported in the registry record.

The registry lists multiple secondary outcomes in addition to the primary waist-circumference measure. It also reports 24 outcome measures and 48 analyses. The original analysis plan and the relationship between those counts and the registry’s reported results are not reported in the registry record. Without that context, it is not possible to determine which analyses were planned in advance, how many comparisons were considered for inference, or whether any adjustment was applied.

Missing data create a separate concern. The primary endpoint description says that all participants, including those who dropped out before the end, were taken into account under an intention-to-treat approach. The record does not describe how missing Week 12 measurements were handled, whether values were imputed, or whether sensitivity analyses were performed. An intention-to-treat label describes the intended population principle, but it does not by itself specify a missing-data method.

The primary outcome summaries list 12 participants in the dapagliflozin arm and 11 in the placebo arm. The enrollment figure is 24, and the registry record does not explain the discrepancy between enrollment and the arm counts reported for this outcome. Safety denominators are listed separately. The record does not report a participant flow account that would clarify the counts, exclusions, or endpoint availability.

These gaps do not invalidate the posted summaries, but they limit assessment of robustness and selective reporting. Caution is warranted when interpreting both the primary estimate and the collection of secondary results.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry’s serious adverse event summary lists 12 participants at risk in each arm and zero serious adverse events in both the dapagliflozin and placebo groups. It lists zero deaths in each group. For other, non-serious adverse events, the summary lists 1 affected participant among 12 at risk in the dapagliflozin arm and 0 among 12 at risk in the placebo arm.

These are the safety counts reported in the registry record. A zero count in a group does not establish that an event cannot occur, and the small listed safety denominators limit how much can be inferred about uncommon events. The record does not provide serious adverse-event terms, because no serious terms are listed, or detailed descriptions of the non-serious event, its timing, severity, or relationship to treatment.

The safety summary is descriptive and should not be read as a comprehensive safety assessment. It does not establish that the two groups had the same safety experience, nor does the one reported non-serious event establish a treatment-related cause. Safety interpretation is limited to the counts and denominators recorded.

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

The primary result describes Week 12 waist circumference in the randomized groups. The recalculated mean difference is 0.4 centimeters, and its confidence interval, from -6.079 to 6.879 centimeters, includes values on either side of zero. This is an imprecise estimate that does not establish a clear difference between the groups. It also does not establish that the treatments are equivalent or that any possible difference is unimportant.

The result is specific to the registered study population, assigned interventions, outcome, and follow-up time. The registry describes participants with metabolic syndrome X and a 90-day daily capsule regimen. It does not report a clinical threshold for interpreting the measured difference, or provide enough detail to assess how missing outcome measurements were handled. The study’s broader stated aim includes insulin sensitivity and insulin secretion, but the primary endpoint is waist circumference; that endpoint alone does not answer every part of the broader aim.

The recalculation is unadjusted and uses the posted group summaries. The registry reports separate within-arm Wilcoxon analyses and indicates a discrepancy; the sponsor’s own analysis takes precedence. Those entries, however, do not provide a direct between-arm estimate in the information reported. This distinction matters: evidence of a change within one arm is not equivalent to evidence that the change differs from the comparator arm.

The posted data do not prove no effect, prove benefit, establish harm, or resolve the study’s full metabolic questions. A confidence interval expresses uncertainty under the calculation’s assumptions, while a p-value does not quantify clinical importance. The record also does not report an equivalence margin, a comprehensive statistical plan, or a clinical-importance threshold. The most defensible interpretation is therefore narrow: the available primary summaries yield a small estimated mean contrast with substantial uncertainty, and the registry’s reported analyses do not provide a directly interpretable comparative estimate.

18. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison should be interpreted through the difference between groups rather than through separate tests within each group. A small p-value for a within-arm analysis does not show that the intervention group changed more or less than the placebo group. The between-group estimate directly addresses the randomized treatment question, while its confidence interval conveys how imprecise that estimate is.

It also demonstrates that a near-zero point estimate is not the same as evidence of no effect. The interval for waist circumference spans values below and above zero, so the available data leave uncertainty about both direction and magnitude. Equivalence cannot be inferred without a prespecified margin and a suitable design and analysis.

The discrepancy between the sponsor’s reported analyses and the simple recalculation underscores the value of transparent reporting. Group means and standard deviations allow readers to understand a basic contrast, but they cannot reveal all modeling decisions, missing-data methods, or analysis populations. Detailed reporting of a prespecified statistical plan and a direct treatment contrast would make the primary result easier to evaluate.

Finally, the sample-size illustrations show how planning depends on the target effect. A smaller effect requires more participants per arm to detect under the stated assumptions. Such calculations are not evidence that the completed trial had adequate or inadequate power; they are reminders that estimates from small studies can be uncertain and should be used cautiously in planning later research.

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.

The primary endpoint summaries are based on limited listed arm counts, and the confidence interval is broad. This constrains the precision of the estimated difference. The registry record reports enrollment of 24 but gives primary outcome counts of 12 and 11; it does not explain the discrepancy. It also does not provide a participant flow account or clarify whether all randomized participants had observed Week 12 measurements.

Although the primary endpoint description states an intention-to-treat population that includes participants who dropped out, missing-data handling is not described. The record does not report whether imputation, a model-based approach, or sensitivity analysis was used. This limits evaluation of how well the reported result represents the intended population.

The registry’s sponsor-reported analyses are presented as separate Wilcoxon (Mann-Whitney) results for each group, without a direct treatment contrast estimate or confidence interval in the reported entries. The record indicates a discrepancy with the unadjusted recalculation but does not explain its source. The original statistical analysis plan, covariate adjustment, and interim-analysis details are not reported in the registry record.

The study includes multiple outcomes, but a multiplicity strategy is not reported. The clinical threshold for an important waist-circumference difference is also not reported. These omissions make it difficult to judge the clinical meaning of the estimate or the evidential weight of secondary results. The registry’s double-masked randomized design is a strength as described, but details of allocation concealment and masking procedures are not reported. These limitations call for restraint rather than a definitive conclusion about treatment effect.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion — NCT02113241.
• Registry record last updated 2020-10-28; status last verified 2020-10.
• Results first posted 2020-10-08.
• 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

NCT02113241 is a completed randomized, double-blind, parallel-group study sponsored by the University of Guadalajara. It is registered as Phase 2 and Phase 3 and concerns metabolic syndrome X. The registry reports enrollment of 24, a study start of 2014-04, and primary completion in 2015-05.

The intervention was dapagliflozin capsules, 10 mg, once daily before breakfast during 90 days; the comparator was matching placebo as described in the record. The primary endpoint was mean waist circumference at Week 12 in centimeters. The posted group means were 97.6 for dapagliflozin and 97.2 for placebo. The unadjusted recalculation estimates a mean difference of 0.4 centimeters, with a confidence interval from -6.079 to 6.879 and an unadjusted p-value of 0.904.

The registry also reports arm-specific Wilcoxon analyses and flags a discrepancy with the recalculation. The sponsor’s own analysis takes precedence, while the reported entries do not give a direct comparative estimate. The record’s detail on missing data, multiplicity, and the original analysis plan is limited.