Glycemia in Diabetic Elders Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Glycemia in Diabetic Elders Trial (NCT02029846), a randomized phase 4 study. The primary outcome is Time to Achieve Glycemic Target (HbA1c <7.5%)..

2. Clinical Question

The clinical question concerns the time to reach a specified glycemic threshold under two treatment approaches. The registry summary also describes a broader hypothesis: compared with traditional drugs alone, a regimen including newer drugs might achieve the target faster and be associated with less hypoglycemia, weight gain, and other side effects over the short run. That statement is the investigators’ hypothesis, not a reported finding.

The primary outcome description says the data were not analyzed because there was n=1 each arm. Consequently, the registry record does not report a comparative estimate of time to target or its precision. It also does not report whether either participant reached the target during the stated timeframe. The clinical question is therefore identifiable, but the posted record does not provide an analyzed comparison that answers it.

3. Trial Design

The Glycemia in Diabetic Elders Trial is listed as a phase 4, randomized, single-masked, parallel-group study of drug interventions for type 2 diabetes mellitus. The two named regimens are Standard Treatment and Incretin-Based Treatment. The arm descriptions distinguish traditional drugs only from a regimen including incretin-based drugs. Which people were masked, and how masking was implemented, are not reported in the registry record.

The record lists enrollment as 2. Its brief summary, in contrast, characterizes the study as a pilot randomized controlled trial of 30 elderly patients. The primary outcome description states that there was n=1 each arm. These entries are not reconciled in the registry record, so the enrolled population and the relationship between the summary and posted outcome information are unclear.

The study start is listed as 2013-04, primary completion as 2017-02, and status as terminated. A reason for termination is not reported in the registry record. Johns Hopkins University is listed as sponsor. The record identifies an overall hypoglycemia measure by glucose meter as a secondary outcome and lists 3 outcome measures, but does not give analyzed results for the primary outcome.

Randomization describes how assignment is intended to reduce systematic differences between treatment groups, while a parallel design assigns participants to one group rather than having them cross between regimens. Those general design features do not resolve the limitations of the posted data: with n=1 each arm and no primary analysis, a randomized allocation does not yield a useful estimate of the treatment contrast in this record. Further details about allocation procedures, the randomization sequence, and the masking process are not reported.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data not analyzed due to n=1 each arm.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Time to Achieve Glycemic Target (HbA1c <7.5%)., measured over 6 months.

The primary endpoint is titled “Time to Achieve Glycemic Target (HbA1c <7.5%).” It concerns the elapsed time until a participant reaches the stated HbA1c threshold, with a timeframe of 6 months. HbA1c is a measure used to assess glycemic status; the endpoint expresses the target as a threshold rather than as a change from a baseline value.

In general, a time-to-event endpoint can capture both whether an event occurs and how long it takes to occur. For this outcome, reaching the specified target would be the event of interest. Such an endpoint can be useful when the timing of reaching a goal matters, rather than only the measurement at a single visit. Its interpretation depends on how the event and observation period are defined, and on how people who do not reach the target or whose follow-up ends early are handled.

The registry record does not report a unit, a statistical parameter, or a dispersion measure for this endpoint. It also does not provide analyzed times, an estimate comparing arms, or details on censoring or follow-up for individual participants. Most importantly, the outcome description states that the data were not analyzed due to n=1 each arm. The record therefore specifies what the endpoint was intended to measure, but does not report an estimate of time to target or a comparison between regimens.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies a randomized, single-masked, parallel-group design and a primary time-to-target outcome. It does not report the statistical analysis used for that outcome. The explanations below describe general statistical concepts relevant to such an endpoint; they are not a claim that the trial used any particular method.

What does time to target measure?

In general, a time-to-event outcome records the time until a defined event occurs. Here, the named event is reaching HbA1c <7.5%. A time-to-event analysis can use information about both the occurrence and timing of the event. It also needs rules for participants who do not reach the target during observation, or whose outcome is not observed through the planned period. Those rules, including any censoring approach, are not reported in the registry record.

A comparison could be expressed in several ways, depending on the prespecified estimand and statistical plan. For example, an analysis might compare event-time distributions or estimate a relative event rate. These are general possibilities, not methods documented for this trial. The registry record does not state which summary measure was intended, how baseline factors would be handled, or what model would be used.

Why does the analysis matter?

Random allocation can support a fair comparison by reducing systematic differences at assignment, but it does not itself produce a treatment-effect estimate. An estimate requires outcome data and an analysis. The record says the primary data were not analyzed because there was n=1 each arm. With no reported estimate, readers cannot determine the observed contrast or judge its uncertainty.

In general, a confidence interval communicates statistical uncertainty around an estimate. Narrow intervals indicate greater precision under the model and assumptions used; wide intervals indicate less precision. A p-value, when reported, addresses compatibility between data and a specified null hypothesis under a statistical model. Neither a confidence interval nor a p-value is reported for this primary outcome. The absence of these quantities should not be interpreted as evidence that the arms were equivalent or that no effect exists.

What is over-dispersion, and is it relevant?

In general, over-dispersion occurs when observed variation is greater than a statistical model assumes. It can matter for count outcomes because standard errors may be too small if the model understates variability. The listed secondary outcome, overall hypoglycemia measured by glucose meter, could involve event or count information, but the record does not give its result format, distribution, or analysis. There is therefore no basis to say whether over-dispersion was assessed or whether a particular count model was appropriate in this trial.

How should planning assumptions be read?

The record describes sample-size planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect, and that time-to-event illustrations use total events while other illustrations use participants per arm. These are planning assumptions, not evidence about the trial’s observed effect and not a report of the trial’s design rationale. No numerical planning results are reported in the record excerpt. Such planning values, when available, would be illustrative calculations rather than observed power.

In general, planning calculations depend on a target effect, variability or event assumptions, a significance threshold, and a desired power. If an observed effect from a very small study is used as the planning basis, that estimate may be highly uncertain. The record does not report a sample-size justification, the target power for the original trial, or a protocol-based calculation. No such rationale can be inferred from the planning-assumptions statement.

What can be concluded from the posted analysis information?

The primary outcome entry explicitly says the data were not analyzed due to n=1 each arm, and the record lists 0 analyses. The primary outcome also was not reduced to one comparison because it had several categories or time points. The record does not describe a prespecified primary contrast, a statistical model, a multiplicity procedure, or an analysis population. Thus, the endpoint definition and design labels can be described, but a quantitative primary treatment comparison cannot be reconstructed from the posted information.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 3 outcome measures and names overall hypoglycemia measured by glucose meter as a secondary outcome. The primary outcome entry is time to achieve HbA1c <7.5% over 6 months. The outcome information was not reduced to one comparison because the primary outcome had several categories or time points. The record does not identify which category or time point would define a single primary contrast.

In general, testing multiple outcomes, time points, or subgroup comparisons can increase the chance of at least one apparently notable result by chance. Statistical plans may address this through a prespecified hierarchy or an adjustment for multiplicity. No multiplicity strategy is reported in the registry record, and the primary data were not analyzed. There are therefore no posted primary comparisons whose multiplicity-adjusted interpretation can be evaluated.

The record does not report how missing observations were defined or handled, whether any participants withdrew, or whether follow-up was complete. These details are especially relevant to a time-to-target endpoint because the analysis depends on how participants without an observed target event are treated. The record also does not identify an intention-to-treat, per-protocol, or other analysis population. The stated n=1 each arm explains why the primary data were not analyzed, but does not provide information about missing-data methods or analysis populations.

The registry record’s 0 analyses should not be read as evidence that missingness or multiplicity had no effect. They indicate that no analysis is listed. Without an analysis plan and analyzed results, the handling of these issues is not reported in the registry record.

11. 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 0% reporting threshold.

The posted adverse-event entries list 1 participant at risk in each arm for serious events and 0 affected in each arm. For other events, the entries likewise list 1 at risk in each arm and 0 affected in each arm. Deaths are listed as 0 in both arms. These are the counts reported in the registry record.

In general, “at risk” identifies the group against which an event count is reported, while “affected” is the count with at least one recorded event in that category. With only 1 at risk in each arm, the entries provide a narrow descriptive snapshot, not a precise estimate of event frequency in a wider population. Zero reported events in these entries do not demonstrate that risk is absent, and they do not establish a safety difference or equivalence between regimens.

The record does not list serious-event terms, and it does not provide additional detail about event definitions, observation duration for safety, or ascertainment procedures. Overall hypoglycemia is named as a secondary outcome measured by glucose meter, but an analyzed result is not reported in the registry record. The broader safety hypothesis in the brief summary is not a posted finding. The event counts should therefore be read as recorded observations only, without inferring more than the listed counts.

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

The record documents a randomized comparison of a traditional-drug regimen with an incretin-based regimen and defines a primary question about time to reach HbA1c <7.5%. It also records safety counts and identifies overall hypoglycemia as a secondary outcome. These details describe the intended comparison and the outcomes selected for recording.

The primary outcome was not analyzed because the record states n=1 each arm. The posted information therefore does not estimate how much faster one regimen reached the target, whether either participant reached it, or how uncertain a treatment contrast would be. No primary p-value or confidence interval is reported. This is not a finding of no difference; it is an absence of an analyzed primary comparison.

The adverse-event counts are zero affected in each arm for serious and other events, with one at risk in each arm and no deaths listed. In a record this limited, those counts cannot establish that the regimens are equally safe or that events would not occur with more observation. The secondary hypoglycemia outcome also has no analyzed result reported.

The enrollment entry of 2 and the brief summary’s description of a pilot trial of 30 are not reconciled. Readers should keep those record entries distinct rather than treating one as a correction of the other. The record does not report why the trial was terminated, how the sample size was justified, or what statistical analysis plan was intended.

Overall, the posted record establishes the study question and reports that the primary outcome was not analyzed. It does not support a conclusion about comparative effectiveness or safety. The stated hypothesis remains a hypothesis, not a result demonstrated by the posted data.

13. Why This Trial Matters Statistically

This trial is statistically instructive because it shows the difference between a clearly named outcome and an answerable treatment comparison. A primary endpoint can be specified precisely—in this case, time to reach HbA1c <7.5% over 6 months—while the record still lacks an analyzed estimate. The outcome definition alone cannot tell readers what happened in the two arms.

The record explicitly says that the primary data were not analyzed because there was n=1 each arm. That limitation is central to interpretation: randomization is a design feature, not a substitute for sufficient outcome information or an analysis. With no reported contrast or uncertainty measure, the record cannot distinguish a meaningful difference from substantial uncertainty.

The record also illustrates why registry entries need to be read carefully. Enrollment is listed as 2, while the brief summary describes 30 patients, and the primary outcome entry reports one participant per arm. The record does not explain this difference. Keeping the separate statements visible is more faithful than silently selecting one or attempting to reconcile them.

Finally, a planning illustration is not the same as a trial’s prespecified design rationale or an observed result. The registry record describes general assumptions for planning calculations but does not report a sample-size justification or a numerical primary analysis. For clinical researchers, these distinctions matter when assessing what a registry entry can support: the design and hypotheses may be informative, while the primary efficacy question remains unanswered by the posted analysis.

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 most direct limitation is that the primary outcome data were not analyzed, with the record citing n=1 each arm. No time-to-target estimate, comparison, confidence interval, or p-value is reported. The stated outcome timeframe is 6 months, but the record does not report observed follow-up times or whether the target was reached.

There is an unresolved difference between the enrollment entry of 2 and the brief summary’s description of 30 elderly patients. The primary outcome description gives one participant per arm, but the registry record does not explain how this relates to the summary or whether the entries refer to different stages or populations. The reason the study was terminated is also not reported.

Several methodological details are absent: the identity of those masked, allocation procedures, the statistical model, the analysis population, missing-data handling, and any multiplicity strategy. The record does not report a sample-size justification or an analyzed result for the named secondary hypoglycemia outcome. The adverse-event counts are limited to the posted at-risk and affected figures; event ascertainment details and serious-event terms are not reported.

These limitations constrain interpretation of both benefit and harm. They do not establish that either regimen is ineffective or unsafe; rather, the registry record does not provide enough analyzed information to quantify comparative outcomes. The status is listed as terminated, but no reason is given, so the circumstances of termination should not be inferred.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Glycemia in Diabetic Elders Trial — NCT02029846.
• Registry record last updated 2023-04-18; status last verified 2018-02.
• Results first posted 2017-05-25.
• 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.

18. Record Summary

The Glycemia in Diabetic Elders Trial is listed as a phase 4, randomized, single-masked, parallel-group study sponsored by Johns Hopkins University. It compares standard treatment, described as traditional drugs only, with incretin-based treatment. Type 2 diabetes mellitus is the listed condition. The study start is 2013-04, primary completion is 2017-02, and status is terminated.

The primary outcome is time to achieve HbA1c <7.5% over 6 months. Its data were not analyzed because the record states n=1 each arm. Enrollment is listed as 2, while the brief summary describes a pilot trial of 30 patients; the difference is not explained. The record lists overall hypoglycemia measured by glucose meter as a secondary outcome, 3 outcome measures, and 0 analyses. Serious and other adverse-event entries list 0 affected in each arm, with 1 at risk in each arm; deaths are listed as 0 in both arms.