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 Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009) (NCT01948986), a non-randomized phase 1 study. The primary outcome is Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 Extrapolated to Infinite Time (AUCinf).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01948986 |
| Phase | Phase 1 |
| Condition | Renal Impairment, Type 2 Diabetes Mellitus |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 36 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants included people with type 2 diabetes mellitus (T2DM) and normal, mild, moderate, or severe renal impairment, as well as healthy participants with normal renal function. The registry record reports an enrollment of 36.
Intervention
Each described group received a single oral dose of ertugliflozin 15 mg. The study evaluated pharmacokinetics, pharmacodynamics, safety, and tolerability in the context of renal function.
Comparator
The groups defined by renal function and participant health status provide the study’s comparisons. This was a non-randomized study, so the groups are not randomized, like-for-like treatment arms. The registry record does not describe a placebo or untreated comparison group.
Primary question
How does renal impairment relate to ertugliflozin exposure, measured as the area under the plasma concentration-time profile extrapolated from time zero to infinite time (AUCinf)? The registry record identifies this measure as the primary endpoint but does not report its numerical results.
The study is not designed as a randomized efficacy comparison. Its central statistical question concerns pharmacokinetics: whether the AUCinf values differ across groups characterized by renal function and health status after a single dose. The inclusion of healthy participants with normal renal function gives another reference group, but the record does not characterize that group as a randomized control.
Pharmacodynamics, safety, and tolerability are also named in the study purpose. Urinary glucose excretion over 24 hours is listed as a secondary outcome. The available record does not provide numerical results for that outcome or for the primary endpoint, so the size and precision of any observed differences cannot be described from these registry entries.
3. Trial Design
This is a Phase 1, non-randomized, open-label, single-dose study with a parallel-group model. It enrolled 36 participants and is marked completed. The listed study start is 2013-10-01, and the primary completion date is 2014-10-06. Merck Sharp & Dohme LLC is identified as the sponsor.
Five groups are described: participants with T2DM and normal renal function; participants with T2DM and mild, moderate, or severe renal impairment; and healthy participants with normal renal function. Each group description specifies oral ertugliflozin 15 mg. Because allocation was non-randomized and masking was absent, group membership was not assigned through a concealed random process, and treatment was open-label.
The groups therefore should not be read as randomized treatment arms. Their differences may reflect the characteristics used to define them, including renal-function category and whether participants had T2DM. The registry record does not give enough information to establish that groups were otherwise comparable. These design features are especially relevant when interpreting group contrasts: they are descriptive comparisons within a pharmacokinetic study, not estimates from a randomized treatment-versus-control experiment.
The record identifies a primary pharmacokinetic outcome, AUCinf, and a secondary outcome of urinary glucose excretion over 24 hours. It also lists 30 outcome measures and 22 analyses. Those counts indicate that multiple outcomes and analyses are recorded, but do not by themselves explain which comparisons were planned or how their results were interpreted. The protocol’s sample-size justification and a detailed statistical analysis plan are not reported in the registry record.
The study purpose includes pharmacokinetics, pharmacodynamics, safety, and tolerability. The listed dose is single-dose, so the record does not describe repeated-dose exposure. Details such as participant eligibility criteria beyond the group descriptions, the method used to assign renal-function categories, and any procedures for managing missing measurements 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
| Stage | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) | Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function) |
|---|---|---|---|---|---|
| STARTED | 6 | 8 | 8 | 6 | 8 |
| COMPLETED | 6 | 8 | 8 | 6 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.
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: Renal function groups were based on body surface area (BSA)-unnormalized estimated glomerular filtration rate (eGFR).
| Characteristic | Unit | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) | Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function) | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 8 | 8 | 6 | 8 | 36 | |
| Age, Continuous | Years | 63.2 (full range 3.5) | 66.4 (full range 2.4) | 65.8 (full range 7.9) | 61.2 (full range 10.3) | 64.3 (full range 3.9) | 64.4 (60 to 76) |
| Sex: Female, Male: Female | Participants | 1 | 5 | 4 | 0 | 3 | 13 |
| Sex: Female, Male: Male | Participants | 5 | 3 | 4 | 6 | 5 | 23 |
| Baseline Urinary Glucose Excretion (UGE) | Grams | 8.2 (full range 10.49) | 0.1 (full range 10.21) | 0.2 (full range 0.93) | 2.3 (full range 3.44) | 0.1 (full range 0.04) | 1.8 (0.0 to 29.0) |
| Baseline eGFR | mL/min/1.73 m² | 92.1 (full range 14.10) | 64.7 (full range 7.52) | 37.1 (full range 6.92) | 17.0 (full range 7.51) | 88.5 (full range 11.64) | 60.5 (6.8 to 115.0) |
| Baseline Inhibition of Glucose Readsorption | Percentage | 2.7 (full range 3.45) | 0.1 (full range 5.17) | 0.3 (full range 1.05) | 3.3 (full range 19.42) | 0.0 (full range 0.02) | 1.1 (0.0 to 50.4) |
| Baseline Fluid Balance | Milliliters | -644.0 (full range 668.11) | -274.8 (full range 570.44) | 238.8 (full range 763.10) | -267.5 (full range 430.85) | -359.5 (full range 693.65) | -243.1 (-1780.0 to 1055.0) |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 Extrapolated to Infinite Time (AUCinf), measured over Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | ng•hr/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the plasma concentration-time profile for ertugliflozin from time zero extrapolated to infinite time, abbreviated AUCinf. It summarizes plasma drug exposure over time, including the portion estimated beyond the last measured concentration. The record describes blood sampling from predose through 96 hours post-dose and says ertugliflozin concentrations were determined from those samples.
AUCinf is useful in pharmacokinetic assessment because it represents overall exposure rather than a concentration at only one sampling time. Comparing exposure across the renal-function groups can address whether the group classifications are associated with different ertugliflozin concentration profiles after the same listed dose. It is an exposure measure, not itself a clinical efficacy outcome.
The registry record specifies that the endpoint is reported as a geometric mean, with geometric coefficient of variation as the measure of dispersion. A geometric mean is appropriate for quantities that are analyzed on a multiplicative scale, such as concentrations or exposure values that may be skewed. The geometric coefficient of variation describes relative variability on that scale. These summaries do not reveal the actual group estimates unless numerical results are reported.
The analysis population is defined as all treated participants with at least one concentration measurement for AUCinf. The registry record does not provide the AUCinf estimates, their geometric coefficients of variation, or confidence intervals. Consequently, the magnitude and precision of the primary endpoint cannot be assessed from the information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes what the primary pharmacokinetic outcome was and which groups were studied, but it does not report the numerical AUCinf results. Without group estimates or a stated contrast, it is not possible to describe the observed direction or magnitude of exposure differences, or to judge their statistical precision. The same limitation applies to the listed secondary outcome of urinary glucose excretion over 24 hours: its outcome name is present, but numerical findings are not.
The study’s non-randomized, parallel-group design calls for cautious interpretation of group differences. Participants were categorized by renal function and by whether they were healthy or had T2DM; they were not assigned at random to those characteristics. Any differences in measured exposure would therefore be descriptive associations among these groups. The record does not establish that other participant characteristics were balanced or that any observed contrast could be attributed to renal impairment alone.
The group structure also matters. The T2DM group with normal renal function and the healthy group with normal renal function are distinct populations, not interchangeable versions of a single control group. A contrast between either group and a group with renal impairment would involve both the renal-function categories and the underlying group definitions. The record does not provide adjusted analyses or enough details to determine whether such factors were accounted for.
The primary endpoint uses geometric means and geometric coefficients of variation. These summarize exposure and its relative variability, but no numerical values are reported in the registry record for any group. A statement about whether values were similar, higher, or lower would therefore go beyond what the registry record reports. Nor is there a reported confidence interval or test result for the primary outcome from which to evaluate uncertainty.
The adverse-event figures describe counts within each study group. Serious adverse events are listed as affecting zero participants in each group. Other adverse events are listed as affecting 1 of 6 participants in the T2DM normal-renal-function group, 2 of 8 in the T2DM mild-impairment group, 1 of 8 in the T2DM moderate-impairment group, 3 of 6 in the T2DM severe-impairment group, and 4 of 8 in the healthy normal-renal-function group. These are group-level counts, not evidence of causal differences between groups. Death counts are not reported in the registry record.
In short, the record supports a description of the study design, endpoint definition, group-specific adverse-event counts, and the limits of interpretation. It does not supply the numerical primary endpoint findings needed to characterize exposure contrasts or their precision. No conclusion about clinical benefit or harm follows from the design description alone.
9. Statistical Methods Explained
The statistical approach should be read in light of the study’s purpose and design. This is a pharmacokinetic study organized around groups with different renal-function categories, not a randomized experiment comparing assigned treatments. The listed dose is ertugliflozin 15 mg in each described group. That consistency makes the group structure relevant to studying exposure, while the non-randomized allocation means that group contrasts are not protected from differences in participant characteristics.
What AUCinf represents
AUCinf is the area under the plasma concentration-time profile, extrapolated from time zero to infinite time. Concentrations were measured from predose through 96 hours post-dose, according to the record. The measured concentrations trace the time course of drug in plasma; the area under that curve summarizes exposure over the observation period, with an extrapolated component extending beyond the last measured time. The record does not explain the exact extrapolation procedure or provide participant-level concentration data.
The endpoint is summarized using a geometric mean. In general, geometric summaries are useful when a measure is positive and varies proportionally, rather than by equal additive increments. On a logarithmic scale, multiplicative differences become additive, which can make statistical comparisons of exposure more suitable. This is a general explanation of the method, not a statement about the distribution of the trial’s unreported results.
The geometric coefficient of variation is the reported dispersion measure. In general, a coefficient of variation expresses variability relative to the scale of the mean; its geometric form is aligned with geometric summaries. It helps describe how variable exposure is among participants in a group. No group-specific geometric coefficients of variation are reported in the record, so the actual degree of variability cannot be assessed.
What group contrasts can establish
The parallel groups allow exposure to be described by renal-function category and participant group. However, this is not a randomized comparison. Randomization is a design method for balancing measured and unmeasured characteristics across assigned groups on average. Here, participants were classified into groups rather than randomly allocated to renal-function status. Consequently, observed contrasts can describe the groups but do not, by themselves, isolate a causal effect of renal impairment.
The distinction between participants with T2DM and healthy participants is also important. The group with T2DM and normal renal function is not the same population as the healthy group with normal renal function. Differences between these groups could reflect more than renal function. The registry record does not report adjusted estimates, matching procedures, or other methods that would clarify how such differences were handled.
Analysis population and measurement availability
For AUCinf, the analysis population is defined as treated participants who had at least one concentration measurement for the endpoint. This definition links inclusion to having received the study drug and having a concentration observation. It does not state how many participants met that condition in each group, whether every included participant contributed a complete concentration profile, or how missing concentration measurements were handled. Those details are not reported in the registry record.
In general, an analysis population definition matters because conclusions apply to the participants included in the analysis, and different inclusion rules can lead to different estimates. For a pharmacokinetic endpoint, incomplete sampling may affect the ability to characterize a concentration-time profile. The record does not describe imputation, sensitivity analyses, or other missing-data procedures, so no account of their use can be given.
Multiplicity and statistical planning
The record lists 30 outcome measures and 22 analyses. Multiple endpoints or comparisons can raise a multiplicity question: when many statistical tests are conducted, the chance of at least one apparently notable result may increase. General approaches can include prespecifying a primary comparison or adjusting inference, but the record does not report whether such procedures were planned or used. The listed outcome and analysis counts alone do not establish the testing strategy.
The sample-size assumptions describe planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. For time-to-event tables, the illustrations concern total events; for other outcomes, they concern participants per arm. These are planning illustrations, not observed power and not the trial’s own design justification. The actual illustration values are not reported in the registry record described for this analysis.
Confidence intervals, when available, communicate the statistical uncertainty around an estimated quantity or contrast. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. No primary endpoint confidence intervals or estimates are reported in the registry record, so precision cannot be characterized for AUCinf. The record also does not report the trial’s planned statistical tests, covariate adjustments, interim analyses, or sample-size justification.
10. Multiplicity, Missing Data and Analysis Populations
Several features of the record are relevant to multiplicity, missing data, and analysis populations, but the details needed to assess these topics are limited. The registry lists 30 outcome measures and 22 analyses. When many outcomes or comparisons are examined, multiplicity can affect how individual statistical findings should be interpreted. The record does not state whether comparisons were prespecified in a hierarchy, whether an adjustment for multiple testing was used, or how confirmatory and exploratory analyses were distinguished.
The primary AUCinf analysis population is defined as all treated participants with at least one concentration measurement for that endpoint. This identifies a basic inclusion condition but does not report the number analyzed in each group. It also does not specify how incomplete profiles, unusable samples, or missing concentration measurements were treated. Missing-data methods, exclusions after treatment, and sensitivity analyses are not reported in the registry record.
The registry identifies 36 participants as enrolled, but enrollment alone does not establish how many contributed to each endpoint analysis. The record does not provide an analysis-population flow or group-specific counts for the primary outcome. It is therefore not possible to determine from these registry entries whether the endpoint analysis included everyone enrolled or how much information was available for each group.
The sample-size material is described as a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such an illustration is not a record of the trial’s design rationale or an observed-power calculation. The protocol’s sample-size justification and any interim-analysis plan are not reported in the registry record.
Because numerical primary endpoint findings are not reported, neither multiplicity-adjusted inference nor the impact of missing observations on the estimates can be evaluated from the information available.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| T2DM Normal Renal Function | 0 | 6 | 0.0% |
| T2DM Mild Renal Impairment | 0 | 8 | 0.0% |
| T2DM Moderate Renal Impairment | 0 | 8 | 0.0% |
| T2DM Severe Renal Impairment | 0 | 6 | 0.0% |
| Healthy Normal Renal Function | 0 | 8 | 0.0% |
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 |
|---|---|
| T2DM Normal Renal Function | 1 of 6 |
| T2DM Mild Renal Impairment | 2 of 8 |
| T2DM Moderate Renal Impairment | 1 of 8 |
| T2DM Severe Renal Impairment | 3 of 6 |
| Healthy Normal Renal Function | 4 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | T2DM Normal Renal Function | T2DM Mild Renal Impairment | T2DM Moderate Renal Impairment | T2DM Severe Renal Impairment | Healthy Normal Renal Function |
|---|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | 0 of 6 | 1 of 8 | 0 of 8 | 2 of 6 | 0 of 8 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 0 of 6 | 0 of 8 | 0 of 8 | 1 of 6 | 1 of 8 |
| Constipation | Gastrointestinal disorders | 0 of 6 | 0 of 8 | 0 of 8 | 0 of 6 | 1 of 8 |
| Catheter site erythema | General disorders | 1 of 6 | 0 of 8 | 0 of 8 | 0 of 6 | 0 of 8 |
| Vessel puncture site haemorrhage | General disorders | 0 of 6 | 1 of 8 | 0 of 8 | 0 of 6 | 0 of 8 |
| Urinary tract infection | Infections and infestations | 0 of 6 | 0 of 8 | 1 of 8 | 0 of 6 | 0 of 8 |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 0 of 8 | 1 of 8 | 0 of 6 | 0 of 8 |
| Ecchymosis | Skin and subcutaneous tissue disorders | 0 of 6 | 0 of 8 | 0 of 8 | 0 of 6 | 1 of 8 |
| Rash papular | Skin and subcutaneous tissue disorders | 0 of 6 | 0 of 8 | 0 of 8 | 0 of 6 | 1 of 8 |
The registry record lists serious adverse events as affecting 0 participants in each of the five groups. The numbers at risk are 6 for T2DM with normal renal function, 8 for T2DM with mild renal impairment, 8 for T2DM with moderate renal impairment, 6 for T2DM with severe renal impairment, and 8 for healthy participants with normal renal function. The record also lists other adverse events affecting 1, 2, 1, 3, and 4 participants in those respective groups.
These counts should be read within their group context. The groups are small and non-randomized, and they differ in renal-function category or participant status. Counts alone do not establish that one group had a higher underlying risk, or that an event was caused by ertugliflozin. The record does not provide event names in the listed serious-event terms, severity detail for other events, or a comparative statistical analysis of these counts.
Deaths are not reported in the registry record. A missing death count should not be interpreted as a reported count of zero. The adverse-event summaries describe what is recorded for this study, but do not by themselves establish comparative safety across groups.
12. What the Result Does, and Does Not, Mean
The study addresses a focused pharmacokinetic question: how ertugliflozin exposure, measured by AUCinf, is described across groups with different renal-function classifications and participant characteristics after a single oral dose of 15 mg. Its Phase 1, open-label, non-randomized, parallel-group design is consistent with describing exposure across those groups. The registry record also identifies pharmacodynamics, safety, and tolerability as areas of evaluation.
What the record does not provide is equally important. It does not report numerical AUCinf values, group contrasts, confidence intervals, or statistical test results. It therefore cannot support a description of the direction, magnitude, or precision of any exposure difference. The named secondary outcome, urinary glucose excretion over 24 hours, is not accompanied by numerical results in the registry record.
The group comparisons are not randomized treatment comparisons. Renal-function category was not assigned at random, and the groups include both participants with T2DM and healthy participants. Differences across them may reflect group characteristics beyond renal function. The record does not identify adjusted estimates that would separate those influences.
The adverse-event counts offer descriptive information: no serious adverse events are listed for the groups, and other adverse events are recorded in each group. These counts are not a causal comparison, and deaths are not reported in the registry record. The counts should not be used to infer that the groups had equivalent safety profiles.
Overall, the study record can establish the research question, broad design, endpoint definition, and selected safety counts. It cannot establish how much exposure varied by renal function, whether any contrasts were statistically precise, or what those contrasts mean for clinical outcomes. It also does not establish treatment efficacy. The distinction is between a study designed to characterize pharmacokinetic measures and the broader clinical claims that would require additional outcome evidence.
13. Why This Trial Matters Statistically
Renal function is a meaningful dimension for pharmacokinetic research because the concentration-time profile of a drug can be examined across groups defined by kidney status. AUCinf provides a summary of overall plasma exposure, while the geometric mean and geometric coefficient of variation describe its central tendency and relative dispersion. These measures help frame a question about how exposure is distributed across the study groups.
The statistical value of this study lies in its structured group descriptions: participants with T2DM and normal, mild, moderate, or severe renal impairment, alongside healthy participants with normal renal function. Considering the groups separately preserves the distinction between renal status and participant health status. Combining them without regard to those differences could obscure what population a comparison represents.
The design also illustrates why the method of comparison matters. A non-randomized study can describe group-specific measurements, but group differences are not automatically attributable to the characteristic used to define the groups. Clear interpretation depends on distinguishing a descriptive pharmacokinetic contrast from a causal treatment effect. That distinction is important even when the administered dose is the same across the described groups.
Finally, the record shows why outcome definitions and numerical reporting both matter. It specifies the AUCinf sampling framework and analysis-population rule, but numerical endpoint results and their uncertainty are not reported in the information available for this analysis. Without estimates and confidence intervals, readers can identify the statistical question but cannot judge the strength or precision of the answer. The adverse-event counts likewise provide a descriptive record, not a comparative safety estimate.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting the primary question is that the registry record does not report numerical AUCinf results. There are no group estimates, contrasts, confidence intervals, or test results in the registry record. The primary outcome can therefore be defined, but its observed magnitude and precision cannot be assessed.
The non-randomized design limits causal interpretation of group differences. Participants were grouped by renal function and by whether they were healthy or had T2DM, so observed differences could reflect these and other group characteristics. The record does not report adjustment methods or enough detail to establish comparability across groups.
The analysis population is described as treated participants with at least one AUCinf concentration measurement, but group-specific analysis counts and missing-data procedures are not reported in the registry record. The record also lists many outcome measures and analyses without specifying a multiplicity strategy. Accordingly, it is not possible to evaluate how incomplete observations or multiple testing may have affected inference.
Safety interpretation is limited to counts. Serious adverse events are listed as zero in each group, but other adverse events are reported as counts without event details in the registry record. Deaths are not reported in the registry record. The small group counts and non-randomized design do not support a reliable causal comparison of adverse-event risk.
Other details not reported in the registry record include the sample-size justification, interim-analysis procedures, and a full statistical analysis plan. The sample-size material is a planning illustration rather than the trial’s own design justification. These omissions constrain assessment of how the study was planned and how its analyses were intended to support conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009) — NCT01948986.
- Registry record last updated 2019-02-18; status last verified 2018-10.
- Results first posted 2019-02-18.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01948986 is a completed Phase 1, non-randomized, open-label, single-dose, parallel-group study sponsored by Merck Sharp & Dohme LLC. It enrolled 36 participants and evaluated ertugliflozin 15 mg across groups with T2DM and different renal-function categories, as well as healthy participants with normal renal function.
The primary endpoint was AUCinf, reported as a geometric mean with geometric coefficient of variation, based on plasma sampling from predose through 96 hours post-dose. The registry also lists urinary glucose excretion over 24 hours as a secondary outcome. Numerical primary endpoint results and their uncertainty are not reported in the registry record.
Serious adverse events are listed as affecting 0 participants in each group; other adverse-event counts are reported by group. Deaths are not reported in the registry record. Because allocation was non-randomized, group contrasts are descriptive rather than randomized treatment comparisons.