Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China (NCT03064841), a registered phase not stated study. The primary outcome is Percentage of Patients Attained Blood Glucose Control Target Defined as Glycated Haemoglobin A1c (HbA1c)<7%, According to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) Guidelines..

2. Clinical Question

The study is intended to describe older patients with type 2 diabetes in a real-life clinical setting, including glucose-target attainment and treatment patterns. Its cross-sectional design captures measurements and clinical information at a study visit rather than following participants over time. Consequently, it can describe the recorded status of the enrolled population, but it is not designed to establish whether a particular treatment caused a change in glucose control or another health outcome.

The title emphasizes albuminuria status, while the primary endpoint is the proportion meeting an HbA1c threshold. The registry lists renal-function outcomes based on albuminuria, estimated glomerular filtration rate, and chronic kidney disease stage, but does not report results for those outcomes either. Any interpretation of differences between renal-status groups would require the actual group-specific estimates and details of the analysis, which are not reported in the registry record.

3. Trial Design

This is a completed, multicentre, cross-sectional, non-interventional study of older outpatients with type 2 diabetes in hospitals in China. Its stated purpose is to describe clinical characteristics, glucose-lowering treatment patterns, and attainment of blood glucose targets in a real-life setting. The registry reports enrollment of 1537 participants. The study started on 2017-03-09 and its primary completion date was 2017-12-30.

Because the study is observational and cross-sectional, participants were not assigned to competing treatment strategies for a controlled comparison. The registry lists one cohort, Outpatient with confirmed Type 2 Diabetes, and an intervention entry called No Treatment. Allocation is not stated. This should not be read as evidence that patients received no diabetes treatment: treatment regimens currently being taken are among the study’s listed outcomes. The record does not describe a randomized allocation or a control arm that would support a treatment-effect comparison.

The primary endpoint is measured at the study visit, with a timeframe of one day. It is the percentage of patients whose HbA1c is below the stated target. The primary analysis population is described as eligible patients who also have an HbA1c measurement. The registry does not report how many enrolled participants met this definition.

Other listed outcomes cover renal function, current diabetes treatment regimens, diabetic complications, hypoglycaemia and related therapy changes, and use of anti-hypertension therapy. There are 12 outcome measures listed in total. The registry does not report detailed procedures for participant selection across hospitals, the age threshold for older patients, the measurement schedule beyond the primary endpoint timeframe, or the statistical analysis plan. The sponsor is Boehringer Ingelheim.

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: All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be included in the study if any of specific entry criteria was violated.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set - Eligible (FAS - E): The FAS - E includes all eligible patients regarding to inclusion and exclusion criteria with an glycated haemoglobin A1c (HbA1c) measurement.

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: Full Analysis Set - Eligible (FAS - E): The FAS - E includes all eligible patients regarding to inclusion and exclusion criteria with an glycated haemoglobin A1c (HbA1c) measurement.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Patients Attained Blood Glucose Control Target Defined as Glycated Haemoglobin A1c (HbA1c)<7%, According to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) Guidelines., measured over At study visit (one day).

The primary endpoint is the percentage of eligible patients attaining the blood glucose target defined as HbA1c <7%, according to the 2015 American Diabetes Association and 2013 Chinese Diabetes Society guidelines. HbA1c is a measure used to assess longer-term blood glucose control. In this study, the endpoint classifies each eligible participant according to whether the measured HbA1c is below the stated threshold at the study visit.

A percentage is useful for describing how common a defined status is within a population. It gives a population-level summary of target attainment, rather than an estimate of how much an individual participant’s HbA1c changed. Since the study is cross-sectional, the endpoint describes status at the visit; it does not capture change over time or establish what caused the observed status.

The registry defines the primary analysis population as the Full Analysis Set - Eligible: patients meeting inclusion and exclusion criteria who have an HbA1c measurement. This definition matters because the percentage depends on which patients contribute to its denominator. The number of patients in that analysis population, the number meeting the target, and the resulting percentage are not reported in the registry record. No confidence interval or other precision estimate for the primary endpoint is reported there.

The threshold is a registry-defined study target. The endpoint should therefore be read as target attainment under that definition, not as a complete description of diabetes status or as a comparison of treatment effectiveness. The registry also lists outcomes concerning albuminuria, estimated glomerular filtration rate, chronic kidney disease stage, and treatment patterns, but their results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a binary percentage: patients are classified according to whether their HbA1c is below the target threshold at the study visit. The core descriptive estimate for such an outcome is the number meeting the definition divided by the number included in the relevant analysis population, expressed as a percentage. The actual numerator, denominator, and percentage are not reported in the registry record, so none can be stated for this study.

What does a percentage estimate describe?

In general, a percentage summarizes the prevalence of a defined status in the population represented by the denominator. Here, the relevant population is not automatically everyone enrolled. The registry defines the primary population as eligible patients with an HbA1c measurement. If some enrolled participants do not meet those conditions, they would not contribute to that primary analysis population under the stated definition. The size and composition of that population are not reported in the registry record.

A percentage is a point estimate: it gives one best summary from the observed participants, but it does not by itself show how precisely that summary estimates the underlying population value. A confidence interval is a general statistical method for communicating uncertainty around an estimate. A narrower interval generally indicates greater precision under the assumptions of the method; a wider interval indicates greater uncertainty. No confidence interval for this endpoint is reported in the registry record.

Why does the study design matter?

As a cross-sectional study, the investigation records characteristics and outcomes at a study visit rather than measuring a planned change from baseline to follow-up. This design is suited to describing the status of the participants at the time of measurement. It does not establish whether an exposure preceded an outcome, and it cannot by itself distinguish cause from association. For example, an observed relationship between current treatment regimen and target attainment would not show that the regimen caused the attainment, because clinical differences between patients may also be related to treatment choice and outcome.

The study is also non-interventional. The registry does not describe assignment to different treatments, and its single listed cohort is outpatients with confirmed type 2 diabetes. The intervention entry, No Treatment, should be understood in the context of the observational design rather than as a claim that participants were untreated. Current treatment regimens are listed as an outcome. A causal comparison would require an appropriate design and analysis details; those details are not reported in the registry record.

What can a comparison by albuminuria status establish?

The study title includes patients with or without albuminuria, and renal function is represented among the listed outcomes. A descriptive comparison between groups could summarize how recorded characteristics differ, if group definitions and estimates were available. Such a comparison would remain observational. It would not automatically establish that albuminuria status caused differences in treatment or glucose control. The registry record does not report the group-specific results, analytic methods, or adjustment strategy.

General methods for comparing percentages may include confidence intervals or statistical tests, but the registry does not identify which methods were used for this endpoint. It is therefore not possible to attribute a particular test, model, or adjustment to the study. The record lists 0 analyses, and detailed statistical procedures are not reported in the registry record.

How should planning calculations be read?

General sample-size planning asks how much information a study might need to detect a specified effect under stated assumptions. The registry’s planning description uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are planning assumptions, not evidence about the study’s actual design. The study is a single-cohort observational investigation, and the record does not describe an allocation between treatment arms. Any planning illustration is not observed power, and it cannot replace an unreported result or confidence interval. The observed effect and numerical planning estimates are not reported in the registry record.

For a percentage outcome, precision depends on the number of participants contributing to the estimate and on how common the outcome is. General statistical methods account for sampling variation, but they cannot account automatically for selection bias, measurement problems, or incomplete recording. The registry does not report sufficient endpoint data to assess numerical precision, and it does not report the missing-data procedures or detailed measurement methods.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Outpatients With Confirmed Type 2 Diabetes Mellitu")
n      <- c(1520)
events <- c(660)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Outpatients With Confirmed Type 2 Diabetes Mellitu  1520  660  43.4  40.9  46.0  40.9  45.9  40.9  45.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures. The primary outcome is the percentage attaining the HbA1c target; the other listed outcomes cover renal function, treatment regimens, diabetic complications, hypoglycaemia and related therapy changes, and anti-hypertension therapy use. When several outcomes are examined, the chance of finding at least one apparently unusual result can increase if many statistical tests are conducted. General approaches to multiplicity include identifying a primary outcome in advance, adjusting inference across tests, or treating secondary findings as exploratory. The registry record does not report a multiplicity procedure or a detailed statistical analysis plan.

The record lists 0 analyses. It does not report whether secondary outcomes were formally tested, whether comparisons by albuminuria status were planned, or how any multiple testing was handled. No significance tests or outcome estimates are available in the registry record, so multiplicity-adjusted conclusions cannot be assessed.

The primary analysis population is defined as eligible patients who have an HbA1c measurement. This definition specifies that a measurement is needed for inclusion in the primary analysis, but it does not explain how missing HbA1c values were handled beyond that definition. The number of enrolled patients without a usable measurement, reasons for missingness, and methods for other missing data are not reported in the registry record.

These details matter because complete-case descriptions can differ from the full enrolled population if participants with recorded measurements differ from those without them. The registry does not report whether missingness was investigated or whether any sensitivity analysis was conducted. It also does not report the number analyzed for secondary outcomes, so their denominators cannot be assumed to match the primary analysis population.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry reports serious adverse event figures for 1520 outpatients with confirmed type 2 diabetes mellitus. In that group, the number at risk is 1520 and the number affected by serious adverse events is 0. The number at risk for other adverse events is also 1520, with 0 affected. Deaths are reported as 0. No serious adverse-event terms are listed among the leading terms.

These are registry-recorded counts, not proof that no adverse events occurred in the broader population or that every event was captured. The record does not report the event collection procedures, observation duration for safety outcomes, or how events were attributed. The study’s primary endpoint timeframe is one day, but that should not be assumed to define the safety observation period, which is not reported in the registry record.

The safety denominator of 1520 differs from the total enrollment of 1537. The registry does not explain the difference or specify why those participants are absent from the safety group. These figures should therefore be read as the posted counts for the stated group, without inferring a reason for the denominator or a rate beyond the reported counts. The study is non-interventional, so these figures do not constitute a randomized comparison of safety between treatments.

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

The record establishes that a completed, nationwide, cross-sectional study enrolled 1537 older outpatients with type 2 diabetes in China and was designed to describe glucose-target attainment, clinical characteristics, and treatment patterns. It defines the primary target as HbA1c <7% at the study visit. It also identifies a primary analysis population requiring eligibility and an HbA1c measurement. These design details clarify what the study set out to describe.

The record does not provide the primary endpoint estimate. It does not state how many patients met the target, how many contributed to the primary analysis, or how precise the estimate was. Therefore, the record cannot support a numerical conclusion about the proportion attaining the target. The absence of a posted result should not be interpreted as a favorable or unfavorable finding.

The observational design is important to what the study can mean. Its findings, if reported, would describe the studied participants and could show patterns in recorded clinical characteristics or current treatment. They would not by themselves show that a treatment caused target attainment or that a treatment should be preferred. Treatment was not assigned by the study, and the registry does not report an adjusted causal analysis.

The title draws attention to albuminuria, but group-specific results and the details of a formal comparison are not reported in the registry record. Likewise, outcomes concerning estimated glomerular filtration rate, chronic kidney disease stage, complications, hypoglycaemia, and treatment patterns are listed without results. Conclusions about these outcomes cannot be drawn from the record.

The serious adverse-event counts are reported as 0 among 1520 participants at risk, with 0 deaths. Those counts describe the registry entries, but event ascertainment and observation details are not reported. They should not be generalized into a claim that adverse events never occurred. Overall, the record offers a study framework and definitions, but not the outcome estimates needed to judge the observed target attainment or its precision.

14. Why This Trial Matters Statistically

Cross-sectional studies can help characterize who is being treated in routine clinical settings and how often a defined target is recorded as attained. This study focuses on older outpatients with type 2 diabetes in China and includes both glucose control and renal-function measures. Its attention to patients with or without albuminuria connects the primary glucose-control question with a clinically relevant description of renal status, while the non-interventional design keeps the conclusions descriptive rather than causal.

Statistically, the study highlights why a clear endpoint definition and analysis population are essential. The primary measure is not simply a percentage among everyone enrolled: it is defined for eligible participants with an HbA1c measurement. Without the denominator and observed count meeting the target, readers cannot assess the estimate or its precision. Reporting confidence intervals and outcome counts would ordinarily help readers distinguish a precise estimate from one with substantial uncertainty; those results are not reported in the registry record.

The study also lists a broad range of outcomes, from renal measures to treatment patterns and hypoglycaemia. Such breadth can make a descriptive profile useful, but it creates a need to distinguish a prespecified primary question from additional exploratory findings and to explain how missing information and multiple comparisons were handled. The registry record does not report those analysis details.

Its value for statistical interpretation is therefore partly in the design question it poses: how should target attainment be described in a defined older outpatient population, and how might that description vary by renal status? The registry record supplies the endpoint definition and study context, but not the numerical results needed to answer those questions. That distinction between a registered question and a reported estimate is central when evaluating clinical evidence.

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 main limitation for interpreting the study from the registry record is that the primary endpoint result is not reported. The numerator, denominator, percentage, and confidence interval are unavailable. Although enrollment is reported as 1537, the primary analysis population is narrower by definition, requiring eligibility and an HbA1c measurement; its size is not reported.

The cross-sectional design captures status at a study visit and cannot establish change over time or causal effects of treatment. The study is non-interventional, and the registry lists one outpatient cohort rather than a randomized treatment comparison. Allocation is not stated. The title refers to patients with or without albuminuria, but the record does not give group definitions, group sizes, group-specific estimates, or a comparison method.

The description of older patients does not specify an age threshold. Detailed inclusion and exclusion criteria, recruitment methods, participating hospital information, and the representativeness of the enrolled population are not reported in the registry record. Those omissions limit assessment of how well the participants reflect older patients with type 2 diabetes more broadly.

The registry lists 12 outcome measures but provides no outcome results and lists 0 analyses. The statistical analysis plan, multiplicity procedures, missing-data handling, and methods for any adjusted comparisons are not reported. The registry also does not explain the distinction between enrollment of 1537 and the safety group of 1520 participants. Safety-event collection and observation details are not reported. These gaps prevent evaluation of precision, missingness, potential selection effects, and the extent to which results could be generalized.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China — NCT03064841.
• Registry record last updated 2019-08-28; status last verified 2019-07.
• Results first posted 2019-08-28.
• 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.

19. Record Summary

The registry describes a completed, multicentre, cross-sectional, non-interventional study of older outpatients with type 2 diabetes in China. Enrollment was 1537; the study began on 2017-03-09 and reached primary completion on 2017-12-30. Boehringer Ingelheim is listed as sponsor.

The primary outcome is the percentage of eligible patients with an HbA1c measurement who attained HbA1c <7% at the study visit, according to the 2015 American Diabetes Association and 2013 Chinese Diabetes Society guidelines. The record lists 12 outcome measures, including renal function, treatment regimens, complications, hypoglycaemia, and anti-hypertension therapy use.

The primary endpoint result, its denominator, and its precision are not reported in the registry record. The record lists 0 analyses. Serious adverse events are recorded for 1520 participants at risk, with 0 affected and 0 deaths. Details of outcome analysis, missing data, and safety ascertainment are not reported in the registry record.