This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2) (NCT02036515), a randomized phase 3 study. The primary outcome is Change From Baseline in Hemoglobin A1C at Week 26.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02036515 |
| Phase | Phase 3 |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 464 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants with type 2 diabetes mellitus who had inadequate glycemic control on metformin and sitagliptin. The primary analysis population included randomized participants who took at least one dose of study medication and had at least one A1C measurement at baseline or after baseline.
Intervention
Ertugliflozin 5 mg or 15 mg, taken orally once daily. The arm descriptions specify treatment for 52 weeks.
Comparator
Matching placebo taken orally once daily for 52 weeks. The comparison was made separately for each ertugliflozin dose.
Primary question
How did hemoglobin A1C change from baseline to Week 26 with each ertugliflozin dose compared with placebo? A1C is a measure of glycemic control, and the trial’s primary objective was to assess A1C-lowering efficacy.
The registry describes a Phase III, randomized, double-blind, parallel-group, placebo-controlled trial. Its stated hypothesis was that adding ertugliflozin would produce a greater reduction in A1C than adding placebo. The primary objective was tested for both the 5-mg and 15-mg doses.
The main comparison is a difference in change between treatment groups, rather than a comparison of the final A1C values alone. That distinction matters because the endpoint is defined relative to baseline. The posted results also include secondary outcomes concerning A1C target attainment, fasting plasma glucose, body weight, sitting systolic blood pressure, and glycemic rescue medication. Those outcomes address related but distinct questions and should not be treated as replacements for the primary comparison.
3. Trial Design
NCT02036515, also known as VERTIS SITA2, is recorded as a completed Phase III clinical trial sponsored by Merck Sharp & Dohme LLC. The registry lists randomized allocation, double masking, and a parallel-group model. Participants were assigned to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo. The listed treatment descriptions specify oral, once-daily treatment for 52 weeks.
The trial focused on participants with type 2 diabetes mellitus and inadequate glycemic control on metformin and sitagliptin. The registry lists an enrollment of 464. For the primary endpoint, the arm-level analysis counts were 156 for ertugliflozin 5 mg, 153 for ertugliflozin 15 mg, and 153 for placebo. These are the reported analysis counts; they should not be read as a statement that every randomized participant contributed every outcome.
The primary outcome was change from baseline in hemoglobin A1C at Week 26. The registry also lists outcomes at Week 52 and other measures, including fasting plasma glucose, body weight, sitting systolic blood pressure, A1C target attainment, and use of glycemic rescue medication. The arm descriptions indicate treatment through 52 weeks, while the primary endpoint comparison is at Week 26.
The registry lists the trial start as 2014-03-12 and primary completion as 2016-06-06. It does not report the detailed allocation procedure, masking procedures, or the operational definition of rescue therapy in the registry record. It also does not report the protocol’s sample-size justification in the registry record. The participant-level analysis plan beyond the stated endpoint population and reported methods is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Two participants were randomized to Ertugliflozin 15 mg, but did not receive any treatment.
Overall Study
| Stage | Ertugliflozin 5 mg | Ertugliflozin 15 mg | Placebo |
|---|---|---|---|
| STARTED | 156 | 155 | 153 |
| Treated | 156 | 153 | 153 |
| COMPLETED | 151 | 143 | 139 |
| NOT COMPLETED | 5 | 12 | 14 |
Reasons for not completing this period:
| Reason | Ertugliflozin 5 mg | Ertugliflozin 15 mg | Placebo |
|---|---|---|---|
| Adverse Event | 1 | 1 | 2 |
| Lost to Follow-up | 0 | 2 | 0 |
| Non-compliance with study drug | 0 | 0 | 2 |
| Screen failure | 0 | 2 | 0 |
| Withdrawal by Subject | 4 | 7 | 9 |
| Hyperglycemia | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All participants as treated population excludes two participants randomized to Ertugliflozin 15 mg but did not receive any treatment.
| Characteristic | Unit | Ertugliflozin 5 mg | Ertugliflozin 15 mg | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 156 | 153 | 153 | 462 | |
| Age, Continuous | Years | 59.2 (SD 9.3) | 59.7 (SD 8.6) | 58.3 (SD 9.2) | 59.1 (SD 9.0) |
| Sex: Female, Male: Female | Participants | 75 | 71 | 53 | 199 |
| Sex: Female, Male: Male | Participants | 81 | 82 | 100 | 263 |
| Hemoglobin A1c (A1C) | Percent | 8.05 (SD 0.86) | 8.00 (SD 0.83) | 8.03 (SD 0.93) | 8.03 (SD 0.88) |
| Fasting plasma glucose | mg/dL | 167.7 (SD 37.7) | 171.7 (SD 39.1) | 169.6 (SD 37.8) | 169.7 (SD 38.2) |
| Body weight | Kilograms | 87.6 (SD 18.6) | 86.6 (SD 19.5) | 86.4 (SD 20.8) | 86.9 (SD 19.6) |
| Estimated glomerular filtration rate (eGFR) | mL/min/1.73m^2 | 87.0 (SD 17.5) | 86.9 (SD 15.6) | 89.9 (SD 17.5) | 87.9 (SD 16.9) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Hemoglobin A1C at Week 26, measured over Baseline and Week 26.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Percent |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in hemoglobin A1C at Week 26, measured in percent. As the registry defines it, the change is the Week 26 A1C percent minus the Week 0 A1C percent. A negative change therefore represents a lower A1C at Week 26 than at baseline. The outcome is reported as a least-squares mean with a 95% confidence interval.
A1C is used as a measure of glycemic control over time. In this trial, measuring change from baseline makes the outcome a comparison of how the measured A1C value shifted during follow-up, rather than simply comparing groups’ values at Week 26. The treatment question is whether the average change differs between each ertugliflozin group and placebo.
The registry notes that laboratory measurements followed an overnight fast of at least 10 hours. It also states that data after initiation of rescue therapy were excluded from the primary endpoint results. The analysis population consisted of randomized participants who took at least one dose of study medication and had at least one A1C measurement, at baseline or post-baseline. This definition does not mean every participant had a Week 26 measurement; the handling of missing measurements is not reported in the registry record.
As a general statistical point, a confidence interval describes the precision of an estimated group mean or contrast under the analysis used. It does not show the range of individual participant outcomes, and it does not by itself resolve questions about missing data, multiplicity, or the practical importance of a difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For ertugliflozin 5 mg, the reported least-squares mean change in A1C at Week 26 was -0.78, with a 95% confidence interval from -0.91 to -0.65. For placebo, the corresponding change was -0.09, with a 95% confidence interval from -0.23 to -0.04. The reported constrained longitudinal data analysis comparison estimated a difference in least-squares means of -0.69, with a 95% confidence interval from -0.87 to -0.50 and p < 0.001.
For ertugliflozin 15 mg, the reported least-squares mean change was -0.86, with a 95% confidence interval from -0.99 to -0.72. Its reported comparison with placebo estimated a difference of -0.76, with a 95% confidence interval from -0.95 to -0.58 and p < 0.001. Because change is calculated as Week 26 minus baseline, both negative between-group estimates indicate a larger mean reduction in the ertugliflozin group than in the placebo group in the posted primary analysis.
The reported confidence intervals for both contrasts lie below zero. This indicates that the estimated contrasts are not close to a no-difference value under the reported analysis. The p-values are also reported as less than 0.001. These inferential results describe the primary comparisons as analyzed; they do not establish the size or direction of every participant’s response.
The arm-level estimates are least-squares means, while the between-arm estimates come from constrained longitudinal data analysis. They are related quantities but are not interchangeable: the contrasts are the direct reported comparisons, and they need not be obtained by subtracting rounded arm-level values. The registry does not report enough model detail to reconstruct the adjustment or covariance structure from the record alone.
The interpretation is limited to the stated endpoint and analysis population. The primary analysis excludes data after rescue therapy was initiated, and the registry record does not describe the missing-data assumptions or sensitivity analyses. It also does not report a multiplicity procedure for testing both doses or for interpreting multiple outcomes. Consequently, the reported p-values should be read as the results attached to the posted comparisons, not as a complete account of the trial’s broader error-control plan.
These findings concern a mean A1C change at Week 26 in the trial population and under the recorded analysis. They do not, on their own, describe longer-term outcomes, individual experience, or outcomes not measured by this endpoint. They should not be generalized beyond the population and comparison recorded without additional evidence.
9. Statistical Methods Explained
For a continuous outcome, such as change in A1C, the main summary can be a group mean. The posted primary arm results are least-squares means, which are model-based estimates rather than necessarily simple arithmetic averages of observed participant values. The registry identifies constrained longitudinal data analysis for the between-group comparisons. Details of the model terms and covariance structure are not reported in the registry record.
What does the change score mean?
The endpoint is defined as the Week 26 measurement minus the baseline measurement. With this convention, a negative value indicates a lower measured A1C at Week 26 than at baseline. The direct treatment contrast compares the mean change in one ertugliflozin group with the mean change in placebo. A negative contrast indicates a greater reduction in the ertugliflozin group, according to the stated subtraction convention.
As a general statistical explanation, analyzing repeated measurements can use information from measurements at more than one time point and account for their relationship. Constrained longitudinal data analysis is a model-based approach to repeated measurements. The registry names this method for the primary comparisons, but its record does not describe the exact implementation, which covariates were included, or how incomplete repeated measurements were handled.
How should the confidence intervals be read?
A 95% confidence interval expresses uncertainty around an estimated contrast under the model and assumptions used. A narrower interval indicates greater precision than a wider interval on the same scale. The interval does not mean that 95% of participants had outcomes within its limits, and it does not capture every possible source of bias or uncertainty.
For the two primary comparisons, the reported estimates and their confidence intervals are negative, with both intervals excluding zero. The p-values are reported as p < 0.001. In general, a p-value measures how incompatible the observed data are with a specified null hypothesis under the statistical model; it is not the probability that the null hypothesis is true. It also does not measure clinical importance.
Why is the analysis population important?
The registry defines the primary analysis population as randomized participants who took at least one dose of study medication and had at least one A1C measurement, either at baseline or post-baseline. This is not described as an analysis of every randomized participant regardless of treatment exposure or outcome availability. The registry also states that data after initiation of rescue therapy were excluded. These choices shape which measurements contribute to the reported endpoint and the question answered by the analysis.
As a general matter, exclusion of post-rescue data can affect interpretation because rescue treatment may be started in response to glycemic control. The registry record does not give enough information to assess the consequences of this exclusion or to determine whether alternative estimands or sensitivity analyses were used. The missing-data method and its assumptions are not reported in the registry record.
Why do secondary comparisons need caution?
The record lists multiple secondary outcomes and comparisons. Each additional statistical test creates another opportunity to observe a small p-value even if there is no underlying difference for that outcome. A multiplicity procedure can address this by adjusting interpretation or testing thresholds across a family of comparisons. Whether a procedure was planned or applied is not reported in the registry record. Accordingly, unadjusted recalculations for secondary outcomes are exploratory descriptions, not a substitute for the sponsor’s prespecified analysis plan.
The binary secondary outcomes are reported as percentages, and the posted recalculations include risk differences and confidence intervals. In general, a risk difference is the difference between the proportions in two groups. A confidence interval gives uncertainty for that difference on the same scale. These calculations are simple, unadjusted re-calculations from the posted summary statistics; they may not match model-based sponsor estimates, particularly where the registry’s analysis adjusts for other features of the data.
Planning illustrations based on an observed effect should also be kept separate from trial results. They estimate participants per arm under stated assumptions and a chosen fraction of the observed effect. They are not observed power and do not establish the original trial’s design rationale. The registry record does not report the trial’s own sample-size justification or the assumptions used by the original planners.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Constrained longitudinal data analysis | Difference in least squares mean -0.69 | -0.87 to -0.50 | < 0.001 |
| cLDA | Difference in least squares mean -0.76 | -0.95 to -0.58 | < 0.001 |
The registry’s reported primary analyses use constrained longitudinal data analysis. For ertugliflozin 5 mg versus placebo, the reported difference in least-squares means is -0.69, with a 95% confidence interval from -0.87 to -0.50 and p < 0.001. For ertugliflozin 15 mg versus placebo, the reported difference is -0.76, with a 95% confidence interval from -0.95 to -0.58 and p < 0.001. These are the sponsor-reported inferential comparisons in the registry record.
The arm-level least-squares mean changes provide context for those contrasts: the estimates are negative in both ertugliflozin groups and in placebo, with larger reductions in the ertugliflozin groups. The direct reported comparisons, rather than a subtraction of rounded arm-level values, are the appropriate source for the sponsor’s model-based contrast and its uncertainty.
The secondary-outcome recalculations are simple unadjusted calculations from posted summary statistics. They answer a different statistical question from a sponsor analysis that may use regression or another model. Where both are available, the sponsor-reported analysis should be distinguished from the recalculation rather than blended into a single estimate. The registry record does not report the full model specification or enough detail to reproduce all of the sponsor’s analyses independently.
11. Multiplicity, Missing Data and Analysis Populations
The registry reports two primary dose-versus-placebo comparisons and multiple secondary outcomes. It does not report in the registry record whether the two primary tests were handled through a hierarchical procedure, a multiplicity adjustment, or another prespecified strategy. The approach to controlling error across secondary outcomes is also not reported in the registry record. This matters because interpreting each test as if it were the only test can overstate the strength of evidence across a large set of comparisons.
The primary population is described as randomized participants who took at least one dose of study medication and had at least one A1C measurement, at baseline or post-baseline. The registry also says that observations after initiation of rescue therapy were excluded from the primary endpoint results. The number and pattern of missing primary measurements, the method used to handle missingness, and sensitivity analyses for missing data are not reported in the registry record.
In general, missing-data methods rely on assumptions about why an outcome is unavailable and how the unobserved value relates to recorded information. Different assumptions can lead to different estimates. Likewise, excluding post-rescue observations defines an analysis that omits those later values; the record does not establish how results would differ under another approach to rescue therapy.
The registry enrollment is 464, while the primary arm analysis counts are 156, 153, and 153. These figures refer to enrollment and reported analysis counts, respectively; the record does not provide a detailed accounting of every participant’s disposition for this endpoint. The sample-size justification, assumptions used for the original design, and any interim-analysis plan are not reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ertugliflozin 5 mg (Phase A+B) | 13 | 156 | 8.3% |
| Ertugliflozin 15 mg (Phase A+B) | 3 | 153 | 2.0% |
| Placebo (Phase A+B) | 8 | 153 | 5.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ertugliflozin 5 mg (Phase A+B) | 24 of 156 |
| Ertugliflozin 15 mg (Phase A+B) | 18 of 153 |
| Placebo (Phase A+B) | 29 of 153 |
Most frequent serious adverse event terms
| Event term | Organ system | Ertugliflozin 5 mg (Phase A+B) | Ertugliflozin 15 mg (Phase A+B) | Placebo (Phase A+B) |
|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 0 of 156 | 0 of 153 | 1 of 153 |
| Angina pectoris | Cardiac disorders | 1 of 156 | 0 of 153 | 0 of 153 |
| Angina unstable | Cardiac disorders | 1 of 156 | 0 of 153 | 0 of 153 |
| Coronary artery disease | Cardiac disorders | 1 of 156 | 0 of 153 | 0 of 153 |
| Goitre | Endocrine disorders | 1 of 156 | 0 of 153 | 0 of 153 |
| Abdominal pain lower | Gastrointestinal disorders | 0 of 156 | 0 of 153 | 1 of 153 |
| Non-cardiac chest pain | General disorders | 0 of 156 | 0 of 153 | 1 of 153 |
| Cholelithiasis | Hepatobiliary disorders | 0 of 156 | 0 of 153 | 1 of 153 |
| Liver disorder | Hepatobiliary disorders | 0 of 156 | 1 of 153 | 0 of 153 |
| Appendicitis | Infections and infestations | 1 of 156 | 0 of 153 | 0 of 153 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ertugliflozin 5 mg (Phase A+B) | Ertugliflozin 15 mg (Phase A+B) | Placebo (Phase A+B) |
|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | 7 of 156 | 5 of 153 | 11 of 153 |
| Nasopharyngitis | Infections and infestations | 8 of 156 | 6 of 153 | 5 of 153 |
| Back pain | Musculoskeletal and connective tissue disorders | 8 of 156 | 3 of 153 | 6 of 153 |
| Urinary tract infection | Infections and infestations | 2 of 156 | 5 of 153 | 8 of 153 |
Serious events with the highest arm-level rate: acute myocardial infarction (0.7%), abdominal pain lower (0.7%), non-cardiac chest pain (0.7%), cholelithiasis (0.7%), liver disorder (0.7%).
The registry reports serious adverse events for each treatment group, with 13 affected participants in the ertugliflozin 5 mg group, 3 in the ertugliflozin 15 mg group, and 8 in the placebo group. The corresponding reported groups at risk are 156, 153, and 153. These are counts of participants with reported serious adverse events; they are not a comparison adjusted for follow-up or other factors.
For other adverse events, the reported affected-participant counts are 24 for ertugliflozin 5 mg, 18 for ertugliflozin 15 mg, and 29 for placebo. These counts should not be combined with the serious adverse event counts, since the registry reports them as separate categories. The registry lists several serious adverse event terms at 0.7% each: acute myocardial infarction, abdominal pain lower, non-cardiac chest pain, cholelithiasis, liver disorder, and bone tuberculosis. Death counts are not reported in the registry record.
As a general statistical point, adverse event counts are descriptive and do not by themselves establish causation or a comparative safety profile. They also do not convey event timing, duration, severity beyond the serious-event classification, or the number of recurrent events. Those details are not reported in the registry record.
13. What the Result Does, and Does Not, Mean
The primary analysis reports a larger mean reduction in A1C at Week 26 for each ertugliflozin dose than for placebo. The sponsor-reported contrasts are negative, their 95% confidence intervals exclude zero, and both p-values are p < 0.001. This is a statistical description of the recorded comparison in the defined analysis population.
The result does not describe the response of every participant. A group mean can conceal variation, including participants whose values changed by more or less than the average. The confidence intervals quantify uncertainty around estimates under the analysis; they are not ranges of individual responses.
The result also does not answer every question about the intervention. The primary endpoint is A1C change at Week 26, not a measure of every aspect of health or a guarantee about outcomes beyond the trial’s follow-up. Although the treatment descriptions specify 52 weeks, the primary comparison is at Week 26. Findings for secondary measures require separate interpretation, particularly where multiple outcomes are tested without a reported multiplicity procedure.
The analysis excludes measurements after rescue therapy was initiated, and the registry record does not report the missing-data assumptions or sensitivity analyses. This limits what can be inferred from the primary estimates about outcomes under alternative ways of handling rescue therapy or incomplete measurements. The reported adverse-event counts are descriptive and do not establish that a treatment caused an event or that one group’s safety profile is definitively different.
Interpretation should remain tied to the enrolled population—participants with type 2 diabetes and inadequate glycemic control on metformin and sitagliptin—and to the stated randomized, double-blind, placebo-controlled parallel-group design. The result is not, by itself, evidence about populations or treatment settings not represented in the registry record.
14. Why This Trial Matters Statistically
This trial illustrates how a clinical question becomes a statistical contrast. The endpoint was not simply the Week 26 A1C value; it was the change from baseline, compared between each dose group and placebo. Stating the subtraction convention makes the direction of the estimated difference interpretable: negative changes correspond to lower values at Week 26, and the reported negative contrasts favor a greater mean reduction in the ertugliflozin groups in this analysis.
It also shows why the model-based comparison deserves attention alongside arm-level summaries. The reported least-squares means describe each group, while constrained longitudinal data analysis supplies the stated between-group contrasts and confidence intervals. Readers should not reconstruct those contrasts by subtracting rounded summaries, because the model-based analysis may use information and assumptions not visible in the rounded arm estimates.
The record further highlights the importance of defining the analysis population and handling intercurrent events. Participants needed at least one dose and an A1C measurement, and post-rescue data were excluded from the primary endpoint results. These decisions define the evidence summarized by the estimate; missing-data and rescue-treatment sensitivity analyses would help clarify how robust the answer is to other assumptions, but they are not reported in the registry record.
Finally, the secondary outcomes demonstrate why statistical significance across multiple comparisons must be interpreted cautiously. Related outcomes can add context, but unadjusted secondary results do not carry the same weight as the designated primary analysis when the multiplicity strategy is not reported. Separating the sponsor’s model-based results from unadjusted recalculations keeps the inferential claims appropriately bounded.
15. 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 registry record does not report the detailed statistical model specification for the primary constrained longitudinal data analysis. Covariates, covariance structure, and the precise treatment of incomplete repeated measurements are not described. This limits independent reproduction of the sponsor’s reported contrasts from the registry record.
The record states that post-rescue observations were excluded from the primary endpoint results, but does not report the number of participants who received rescue therapy before the endpoint or sensitivity analyses addressing that exclusion. The missing-data method and assumptions are also not reported in the registry record. These omissions make it difficult to assess how the primary estimates might change under different approaches to rescue or missing measurements.
The approach to multiplicity across the two primary dose comparisons and the numerous secondary outcomes is not reported in the registry record. Thus, secondary p-values and unadjusted recalculations should be interpreted as descriptive or exploratory unless supported by a prespecified testing strategy not recorded. The original sample-size justification and any interim-analysis plan are not reported in the registry record.
The safety information includes affected-participant counts and selected serious adverse event terms, but the registry record does not report event-level timing, duration, recurrent event counts, or death counts. These summary counts do not support a detailed comparative safety analysis on their own. In addition, the primary result addresses A1C change at Week 26; it does not resolve outcomes beyond the measures and follow-up described in the registry.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2) — NCT02036515.
- Registry record last updated 2018-09-13; status last verified 2018-08.
- Results first posted 2017-07-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT02036515 (VERTIS SITA2) is a completed Phase III, randomized, double-blind, parallel-group, placebo-controlled trial sponsored by Merck Sharp & Dohme LLC. It enrolled participants with type 2 diabetes mellitus and inadequate glycemic control on metformin and sitagliptin. The treatment groups received once-daily ertugliflozin 5 mg, ertugliflozin 15 mg, or matching placebo.
The primary outcome was change from baseline in hemoglobin A1C at Week 26. The reported constrained longitudinal data analysis estimated differences versus placebo of -0.69 for 5 mg and -0.76 for 15 mg; both comparisons had 95% confidence intervals below zero and p < 0.001. The analysis population required at least one dose and at least one A1C measurement, and post-rescue data were excluded.
The registry also reports secondary outcomes and adverse-event summaries. Multiplicity procedures, missing-data assumptions, the original sample-size justification, and detailed model specifications are not reported in the registry record.