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 A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199) (NCT01409213), a registered phase not stated study. The primary outcome is Change From Baseline for Mean Hemoglobin A1c (HbA1C).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01409213 |
| Phase | Phase not stated |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1523 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with type 2 diabetes mellitus receiving care in an office setting. The registry lists 1523 enrolled participants and describes the primary-outcome population as participants in the full analysis set with available data. It does not report the number of participants with available HbA1c measurements or describe participant characteristics in the outcome record.
Intervention
This is a study of current medical practice, not a trial assigning a specified treatment. Its stated purpose was to collect information about participants’ risk profiles and their treatment in relation to guidance published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008. The treatment received by individuals and the distribution of treatment choices are not reported in the registry record.
Comparator
No like-for-like control group is described. The record lists all enrolled participants together, and allocation is not stated. The design is non-interventional, so the registry does not establish a randomized comparison between treatments or between treated and untreated groups. A comparative treatment effect therefore cannot be read from the stated design.
Primary question
The primary question concerns the change in mean hemoglobin A1c (HbA1c) between baseline and the end of observation, up to Month 6. The record defines change as the mean baseline HbA1c minus the mean end-of-observation HbA1c. It does not report the numerical change, its variability, or an uncertainty estimate. The record also does not report whether treatment patterns met the DDG guidance or how that aim was assessed.
3. Trial Design
The registry identifies this as a completed, non-interventional register investigating daily clinical practice for patients with type 2 diabetes mellitus. Its title situates the care in an office setting, and the stated purpose is to describe patient risk profiles and treatment in relation to DDG guidance published on October 13, 2008. The study is not described as assigning treatment or randomizing participants.
The enrollment is 1523. The record lists an all-enrolled-participants group rather than separate treatment groups. Allocation is not stated, and the record cautions that the listed group is not a like-for-like control comparison. As a result, the design supports a description of outcomes observed in routine practice, but the record does not establish a controlled treatment contrast.
The study start is recorded as 2009-08 and primary completion as 2011-01; its status is completed. The primary outcome timeframe is baseline and end of observation, up to Month 6. These dates describe the study record, while the stated outcome timeframe describes the measurement period for an individual participant. The registry record does not report further details about visit schedules or the timing of measurements within that period.
The record lists 2 outcome measures and 0 analysis entries. The primary outcome is change from baseline for mean HbA1c. The available description identifies a full analysis set with available data as the outcome population, but does not provide a participant flow or analysis counts. The registry record does not report the protocol, a sample-size justification for the study, interim analyses, or the statistical plan used for its conduct. Planning illustrations are not a substitute for those design details and should not be treated as the study’s original design assumptions.
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: Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
Overall Study
| Stage | All Enrolled Participants |
|---|---|
| STARTED | 1523 |
| COMPLETED | 1523 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants from the full analysis set with available data.
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.
| Characteristic | Unit | All Enrolled Participants |
|---|---|---|
| Participants analysed | 1522 | |
| Age, Continuous | years | 64.0 (SD 10.8) |
| Sex/Gender, Customized: Female | Participants | 841 |
| Sex/Gender, Customized: Male | Participants | 680 |
| Sex/Gender, Customized: Missing | Participants | 1 |
| Region of Enrollment: Germany | participants | 1522 |
| Hemoglobin A1c (HbA1c) | Percent of glycosylated hemoglobin | 7.4 (SD 1.1) |
| Fasting blood glucose (FBG) | mg/dL | 146.9 (SD 42.0) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline for Mean Hemoglobin A1c (HbA1C), measured over Baseline and end of Observation (up to Month 6).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percent of glycosylated hemoglobin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline for mean HbA1c, measured as percent of glycosylated hemoglobin. The registry defines the change as the mean baseline value minus the mean value at the end of observation, with the end of observation occurring up to Month 6. Under that sign convention, a positive change represents a baseline mean greater than the end-of-observation mean; the registry record does not report an observed change to interpret.
HbA1c is a continuous measure, so its mean can describe the average value in the analyzed group and the average difference between the stated measurement times. In general, such a measure is useful for summarizing change in a clinical marker over follow-up. It does not, by itself, describe how much individual participants varied, whether every participant changed in the same direction, or why a change occurred.
The endpoint description specifies standard deviation as the measure of dispersion. A standard deviation describes the spread of individual measurements around a mean; it is not the same as the uncertainty around the estimated mean change. The registry record does not give the mean change, standard deviation, confidence interval, or other numerical outcome result. It also does not report a threshold defining a clinically important change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable outcome—change in mean HbA1c from baseline to the end of observation, up to Month 6—but does not report its numerical result. It therefore does not establish the direction or magnitude of the observed average change. The stated definition fixes the direction of subtraction: baseline mean minus end-of-observation mean. That definition alone is not evidence that the mean rose or fell.
The endpoint is described as a mean with standard deviation, but neither the mean change nor its variability is reported. No confidence interval, test statistic, or p-value is given in the record. Without an estimate and an uncertainty measure, the precision of the outcome cannot be assessed. The registry lists 0 analysis entries; this means analysis results are not listed in the record, not that no statistical analysis was conducted.
The design also limits what a result could establish. The study is non-interventional and lists all enrolled participants together. Allocation is not stated, and the record explicitly cautions that the listed group is not a like-for-like control comparison. A change observed over follow-up could describe the group’s course during routine care, but this record cannot separate treatment effects from other explanations, such as changes in care or differences among participants. Whether such factors were addressed in an analysis is not reported in the registry record.
The outcome population is described as participants from the full analysis set with available data. That wording indicates the endpoint depends on data availability, but the record does not state how many participants contributed measurements, how much data were missing, or how missing observations were handled. Consequently, the reader cannot assess whether the outcome population represents all enrolled participants or whether missingness could have affected the estimate.
The study’s stated purpose includes describing risk profiles and treatment in relation to DDG guidance. The registry record does not provide numerical results for those aims or explain how guideline alignment was evaluated. Nor does it identify a treatment-specific comparison that could answer whether one approach performed better than another. The evidence available in the record is therefore about the study’s purpose, design, and specified endpoint, rather than a reported estimate of clinical outcome.
9. Statistical Methods Explained
The primary outcome is a continuous measure summarized as a mean. The registry defines the change as the mean HbA1c at baseline minus the mean HbA1c at the end of observation. This subtraction order matters: a positive value would mean the baseline mean is greater than the end mean, while a negative value would mean the end mean is greater. Those are interpretations of the definition, not findings about this study. The numerical result is not reported in the registry record.
What does the mean describe?
In general, a mean combines participants’ measurements into an average for the analyzed group. It can offer a compact description of the group’s level at a given measurement time, or of the average change between measurement times. A group mean does not show the distribution of individual values. Participants may have changes that differ in size or direction even when the average is close to zero. The registry record does not provide participant-level values or a distribution of individual changes.
What does the standard deviation describe?
The endpoint lists standard deviation as its dispersion measure. In general, standard deviation describes how spread out individual observations are around their mean. It is not an estimate of the precision of the mean, and it is not interchangeable with a confidence interval or standard error. A confidence interval, in general, expresses uncertainty around an estimate under the assumptions of the method used. The registry record does not report a confidence interval or identify a method for calculating one.
Because HbA1c is continuous, the mean and standard deviation can be useful summaries, but their interpretation depends on the analyzed data and design. A mean can be influenced by unusually high or low observations. If measurements are strongly skewed or contain influential values, other summaries may also be informative. Whether the distribution was assessed or alternative summaries were considered is not reported in the registry record.
How should a change over time be interpreted?
In general, measurements on the same participant across time are related, rather than independent. An analysis of within-participant change can account for that relationship, but the registry record does not specify the analysis method used. The endpoint definition gives a difference between group means; it does not say whether the reported estimate was calculated from individual paired changes, from separate time-specific means, or with a model. That distinction and any adjustment for covariates are not reported.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. If a model assumes less variation than is present, its uncertainty estimates can be too small and its inferences too confident. The record does not describe a model or its distributional assumptions, so there is no basis for saying whether over-dispersion was relevant or how it was handled in this study.
What do planning illustrations mean?
Any sample-size illustrations associated with these results are planning scenarios, not observed study outcomes and not observed power. The stated assumptions for those illustrations are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. Such scenarios describe hypothetical sample-size requirements under their assumptions. They do not show that the non-interventional study was designed with two randomized arms; the registry lists all enrolled participants together and provides no like-for-like control comparison. The study’s own sample-size justification is not reported in the registry record.
In general, power is a design quantity tied to a specified effect, variability, analysis, and sampling plan. It is not a measure of whether a result is true, and a retrospective planning illustration should not be described as observed power. The record does not give the underlying numerical outcome estimate or the detailed assumptions used to plan the study itself. The illustrations therefore cannot fill the gap in the reported clinical outcome.
What can a p-value or confidence interval add?
In general, a p-value measures how compatible data are with a specified null model under the assumptions of the test; it does not measure the probability that a treatment works. A confidence interval communicates a range of estimates compatible with the data and method, and can help show precision. Neither statistic substitutes for understanding the design, the analysis population, or possible sources of bias. No p-value or confidence interval for the primary outcome is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 2 outcome measures, but the available information identifies only the primary endpoint described as change in mean HbA1c. The other outcome’s definition and results are not reported in the registry record. Because outcomes can involve multiple statistical comparisons, multiplicity can increase the chance of a misleading finding if many tests are conducted and interpreted without an appropriate plan. Whether any multiplicity adjustment or hierarchy was specified is not reported.
The record lists 0 analysis entries. It does not report a statistical analysis plan, interim analyses, or numerical results for the primary endpoint. The absence of analysis entries in the registry record should not be interpreted as evidence that no analyses were performed; it means their details and results are not available in this record.
The primary-outcome population is described as the full analysis set with available data. The record does not give the number included in that endpoint analysis, the number with missing measurements, reasons for missingness, or a method for handling missing data. In general, an analysis restricted to participants with available measurements can be affected if availability is related to health status, treatment, or outcome. Whether that concern applies cannot be assessed without information about missingness and the analysis.
The record does not explain how the analysis population was defined beyond the available-data description, or whether sensitivity analyses were conducted. Those details, along with the treatment of multiple outcomes and any missing-data assumptions, are not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The record establishes that a completed, non-interventional study enrolled 1523 participants and specified change in mean HbA1c from baseline to the end of observation, up to Month 6, as its primary outcome. It also states that the study aimed to collect information about risk profiles and treatment in relation to DDG guidance. These are details about the study’s scope and outcome definition, not evidence of a particular clinical result.
The numerical primary-outcome estimate and its uncertainty are not reported in the registry record. As a result, the record does not show whether the average HbA1c changed, how large any change was, or how precisely it was estimated. It also does not report results on guideline alignment or the risk-profile descriptions in the study’s stated purpose.
The design does not provide a like-for-like control comparison. The study is non-interventional, allocation is not stated, and all enrolled participants are listed as a single group. A change over time in such a group cannot by itself establish that a particular treatment caused the change. Changes may coincide with treatment and routine care, but the record does not provide a comparison or analysis that separates those explanations.
The results should not be interpreted as proof for or against any treatment. The record does not report a treatment-specific effect, numerical outcome estimate, or analysis of safety outcomes that would support such a conclusion. Its stated endpoint is a group-level mean, which also cannot establish how every individual participant’s measurement changed. The available record supports a description of the intended question and design, while the outcome findings and their precision remain unreported.
12. Why This Trial Matters Statistically
This study is statistically relevant because it addresses outcomes in daily clinical practice rather than describing a randomized treatment comparison. Routine-care data can frame questions about the characteristics of patients receiving care and the treatments used in practice. The study’s stated purpose connects those descriptions to DDG guidance published on October 13, 2008. The registry record, however, does not report findings on risk profiles or guideline alignment.
The design makes careful separation of description and causal inference especially important. Without a like-for-like control group, observed change over time is not by itself an estimate of the effect of a specific treatment. Differences among participants, care decisions, and other changes during observation can complicate interpretation. Whether the study used adjustment or other methods to address such factors is not reported in the registry record.
The endpoint also illustrates why an outcome definition is not the same as an outcome result. The registry specifies a mean HbA1c change and its subtraction order, but does not report the estimate or its uncertainty. Without those quantities, readers cannot judge the size or precision of the observed change. The available-data analysis population further makes information about missingness important, yet those details are not reported.
These features matter when interpreting real-world evidence: a clear description of the population, measurement, comparison, analysis, and missing data is needed to understand what a result can support. Here, the record provides the study’s broad purpose and endpoint definition, but not the numerical findings or analysis details necessary to evaluate the primary outcome.
13. 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 central limitation for interpretation is that the registry record does not report the numerical primary-outcome result. The mean change, standard deviation, and any confidence interval or test result are absent. The direction, magnitude, and precision of any observed change therefore cannot be assessed from the record.
The study is non-interventional and lists all enrolled participants together. Allocation is not stated, and the record cautions that the group is not a like-for-like control comparison. Accordingly, the design as described does not support a controlled comparison of treatment effects. Whether analyses adjusted for participant characteristics or other potential confounders is not reported in the registry record.
The endpoint population includes participants in the full analysis set with available data, but the record does not state the analysis count, completeness of follow-up, amount or pattern of missing data, or approach to missing measurements. This leaves uncertainty about how well the analyzed observations represent the enrolled group. The record also does not describe whether the endpoint was calculated from paired individual changes or another analysis method.
The registry lists 2 outcome measures but does not provide full details of the other measure, and it lists 0 analysis entries. A statistical analysis plan, multiplicity approach, interim analyses, and the study’s sample-size justification are not reported in the registry record. These omissions limit assessment of analytic choices and the extent to which results might have been prespecified.
Finally, adverse-event fields list zero participants at risk and affected for serious and other events, while deaths are null and no serious event terms are listed. These registry fields do not establish that adverse events were absent or completely ascertained. The record does not explain the reporting or ascertainment process.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199) — NCT01409213.
- Registry record last updated 2015-08-27; status last verified 2015-08.
- Results first posted 2012-01-23.
- 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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17. Record Summary
NCT01409213 is a completed, non-interventional register concerning type 2 diabetes mellitus in an office setting. It enrolled 1523 participants. The recorded study start is 2009-08 and primary completion is 2011-01. Its stated purpose was to collect information on risk profiles and treatment in relation to DDG guidance published on October 13, 2008.
The primary outcome is change in mean HbA1c, measured as percent of glycosylated hemoglobin, from baseline to the end of observation, up to Month 6. Change is defined as the baseline mean minus the end-of-observation mean, with standard deviation as the stated dispersion measure. The outcome population is described as the full analysis set with available data.
The record lists all enrolled participants as a group, does not state allocation, and does not describe a like-for-like control comparison. It lists 2 outcome measures and 0 analysis entries. Numerical primary-outcome results, analysis details, and missing-data counts are not reported in the registry record.