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 Intravenous Exenatide in Patients With Acute Brain Injury (NCT02058940), a na phase 4 study. The primary outcome is Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02058940 |
| Phase | Phase 4 |
| Condition | Brain Injuries |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Results posted | Yes |
2. Clinical Question
The study asks whether intravenous exenatide can be administered feasibly to critically ill patients with acute brain injury while glucose is monitored over 48 hours from infusion initiation. Its stated purpose is to assess feasibility in the setting of high blood sugars following acute brain injury. The primary outcome concerns the percentage of patients meeting pre-specified feasibility criteria, which combine glucose control with limits on severe hypoglycemia and nausea requiring discontinuation.
Population
Critically ill patients with acute brain injury. The registry lists Brain Injuries as the condition and records an enrollment of 8.
Intervention
Exenatide, administered by intravenous infusion. The record does not give further details about dose or infusion schedule.
Comparator
There is no comparator arm in the recorded design. The study is listed as single-group, with allocation marked NA and masking marked none.
Primary question
Over 48 hours from infusion initiation, what percentage of patients meets the stated feasibility criteria: reaching the glucose goal range of 110-180 mg/dL while meeting the specified limits for severe hypoglycemia and nausea requiring discontinuation?
This is a feasibility question, not a randomized comparison of exenatide against another treatment. The registry record does not report the primary endpoint result, so it is not possible to determine from that record whether the pre-specified criteria were met. The intended clinical setting and the criteria can be described, but an efficacy conclusion cannot be drawn from the registered information.
3. Trial Design
The registry describes NCT02058940 as a Phase 4, completed, single-group study of intravenous exenatide in critically ill patients with acute brain injury. The sponsor is the University of North Carolina, Chapel Hill. The recorded start was 2015-08, and primary completion was 2017-08. Enrollment is listed as 8.
A single-group design means that the registered study does not set out a concurrent control arm for comparison. Allocation is marked NA, masking is none, and the arm description for Exenatide is blank. The design therefore supports a description of what was recorded among participants receiving exenatide, but does not provide a randomized estimate of how outcomes would differ under another treatment or under usual care. The registry itself flags that this is not a randomized comparison and that arms are not a like-for-like control comparison.
The primary outcome is a percentage of patients meeting feasibility criteria during the 48 hours from infusion initiation. Secondary outcomes cover glucose concentration, the percentage of measurements in the goal range, time to reach that range, glycemic variability, insulin use, rescue insulin infusion, and hypoglycemia. Those measures describe different aspects of glucose management and safety; they should not be treated as interchangeable endpoints.
The record labels the study completed, but completion status is not itself a report of results. It lists 19 outcome measures and one analysis, but does not provide the primary endpoint estimate or the numerical results for the listed secondary outcomes. Details such as the exenatide dose, infusion protocol, eligibility criteria, sample-size justification, interim analyses, and full statistical plan are not reported in the registry record. The reason for choosing a single-group feasibility design is also 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 | Exenatide |
|---|---|
| STARTED | 8 |
| COMPLETED | 7 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Exenatide |
|---|---|
| Discharged from Critical Care Unit | 1 |
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 | Exenatide |
|---|---|---|
| Participants analysed | 8 | |
| Age, Continuous | years | 64.0 (58.8 to 67.8) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 7 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | Participants | 8 |
| Primary Admitting Diagnosis: Intracerebral Hemorrhage | Participants | 3 |
| Primary Admitting Diagnosis: Acute Ischemic Stroke | Participants | 3 |
| Primary Admitting Diagnosis: Subarachnoid Hemorrhage | Participants | 1 |
| Primary Admitting Diagnosis: Subdural Hematoma | Participants | 1 |
| Glasgow Coma Scale (GCS) | units on a scale | 10.5 (7.0 to 14.0) |
| Sequential Organ Failure Assessment (SOFA) | units on a scale | 2.0 (1.0 to 4.0) |
| Hunt and Hess Scale | units on a scale | 2.0 |
| Modified Fisher Grade | units on a scale | 3.0 |
| Intracranial Pressure | mmHg | — |
| Cerebral Perfusion Pressure | mmHg | — |
| Past Medical History: Diabetes | Participants | 4 |
| Past Medical History: Hypertension | Participants | 6 |
| Past Medical History: Hyperlipidemia | Participants | 4 |
| Past Medical History: Cardiovascular Disease | Participants | 5 |
| Past Medical History: Chronic Kidney Disease | Participants | 3 |
| Past Medical History: Heart Failure | Participants | 1 |
| Hemoglobin A1c (%) | percent | 6.5 (5.5 to 7.3) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria, measured over Over 48 hours from infusion initiation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of patients |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of critically ill patients with acute brain injury who achieve the study's pre-specified feasibility criteria over 48 hours from infusion initiation. The record defines feasibility using three clinical events or targets: experiencing severe hypoglycemia below 40 mg/dL, achieving glucose measurements within the goal range of 110-180 mg/dL, and experiencing nausea that requires exenatide discontinuation.
The stated feasibility thresholds require at least 75% of patients to achieve glucose measurements within the goal range and no more than 25% to experience severe hypoglycemia or nausea requiring discontinuation. These criteria make the endpoint a practical assessment of whether infusion can be carried out while meeting specified glucose and tolerability conditions. It is not a conventional between-group treatment-effect endpoint because the design has no registered comparator arm.
For this kind of endpoint, the percentage communicates how common criterion attainment was in the enrolled group. Interpretation depends on the numerator, the denominator, the handling of patients with incomplete observation, and the exact rule used to combine the criteria. The registry record does not report the observed primary endpoint percentage, its numerator and denominator, a confidence interval, or detailed handling rules. Thus, it states what the investigators intended to assess, but not how the enrolled group performed against the criteria.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supports a description of the study question and design, but it does not report the primary feasibility result. Although it specifies a goal glucose range and thresholds for severe hypoglycemia and nausea requiring discontinuation, no result is given for the percentage meeting those criteria. Consequently, the record does not establish whether the feasibility target was reached. The absence of a reported endpoint estimate is not evidence that the target was or was not met.
The design is single-group, with no randomized comparator. Any reported event or glucose outcome in such a study would describe observations in the exenatide group. Without a concurrent control group, those observations could not by themselves distinguish effects associated with exenatide from the course of acute brain injury, other care, patient characteristics, or changes over time. This is particularly important for glucose outcomes in a critically ill population, where multiple aspects of clinical management may be relevant. Details of co-interventions are not reported in the registry record.
The enrollment of 8 indicates that the study was small. In general, estimates from a small group are imprecise: a small change in the number of participants meeting a criterion can substantially affect the reported percentage. A confidence interval, if reported, would express uncertainty around an estimate, but the registry record does not give a primary endpoint confidence interval. The record also does not state whether confidence intervals were planned or how they would be calculated.
The registry lists secondary measures that could add context, including the median glucose concentration during infusion, the percentage of glucose measurements in the goal range, time to reach that range, glycemic variability, insulin use, rescue insulin infusion, and hypoglycemia. No numerical results for these outcomes are included in the registry information. The outcome names alone do not indicate the direction or size of any findings.
Safety information is recorded separately: the exenatide group has 3 serious adverse events among 8 at risk, 0 other adverse events among 8 at risk, and 3 deaths. Death is listed among the serious adverse event terms at 37.5%. These are descriptive counts and do not establish that exenatide caused the events. The registry record does not provide enough information about timing, clinical context, attribution, or comparison with another group to support a causal interpretation.
Overall, the registered information identifies a feasibility objective and records a small single-group study, but it does not contain the primary outcome result needed to judge criterion attainment. Any conclusion about the study's success or about comparative treatment effects would go beyond what the registry record reports.
9. Statistical Methods Explained
The following statistical discussion is general. The registry record identifies the endpoint and study structure, but it does not report the full statistical plan or the primary endpoint result.
What does a single-group percentage describe?
A percentage for a binary outcome is the number of participants meeting a defined condition divided by the number assessed for that condition. In this study, the condition is tied to feasibility criteria during the stated observation period. The percentage describes the observed group; by itself, it does not estimate a contrast with a control treatment. The exact numerator, denominator, and primary percentage are not reported in the registry record.
With a small group, each participant's outcome has a substantial influence on the percentage. That makes the estimate sensitive to individual observations and generally limits precision. A confidence interval can show the range of population values reasonably compatible with the observed data under the chosen statistical model. Narrow intervals indicate greater precision and wide intervals indicate more uncertainty. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be assessed from the registered results.
How should the feasibility thresholds be understood?
A feasibility threshold is a decision rule set in advance to guide interpretation. The record specifies a target of at least 75% achieving glucose measurements in the 110-180 mg/dL range, alongside a limit of no more than 25% experiencing severe hypoglycemia or nausea requiring discontinuation. These thresholds turn a broad question about practicality into criteria that can, in principle, be evaluated against the observed participant data.
Thresholds do not remove uncertainty. An observed percentage close to a threshold may be compatible with a range of underlying rates, especially in a small study. Statistical uncertainty and the practical meaning of a threshold are related but distinct: the threshold defines the study's stated criterion, while the estimate and its precision describe the evidence about whether it was met. The record does not provide the endpoint estimate or interval needed to make that assessment.
Why do glucose measurements and participant outcomes differ?
Several listed secondary outcomes are based on glucose measurements, while the primary endpoint is described as a percentage of patients. Repeated measurements from one participant are not equivalent to independent observations from separate participants. In general, analyses of repeated glucose values must account for the fact that values from the same person may be correlated. Treating each measurement as independent can make uncertainty appear smaller than it is.
The percentage of measurements in the goal range is therefore a different quantity from the percentage of participants meeting a patient-level criterion. The median glucose concentration describes the center of the recorded measurements using a robust summary, while glycemic variability concerns how much values fluctuate. Time to reach the goal range addresses timing rather than the overall proportion of measurements or patients. Each outcome answers a distinct question, and one cannot substitute for another.
What does over-dispersion mean in general?
For count or binary outcomes, a statistical model may assume a particular amount of variability. Over-dispersion means the observed variation is greater than the model expects. Ignoring it can lead to standard errors that are too small and confidence intervals that are too narrow. For repeated glucose measurements, dependence within a participant and differences between participants can contribute to extra variability. The registry record does not say whether over-dispersion was assessed or which models, if any, were used for the secondary outcomes.
How should planning illustrations be read?
A sample-size calculation is a planning tool: it estimates how many participants might be needed to detect a chosen effect under specified assumptions. It is not a result from the completed study and is not evidence that a treatment effect was observed. The stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Those assumptions describe a hypothetical two-arm planning framework, not the registered single-group design.
The stated planning approach distinguishes participants per arm for outcomes other than time-to-event outcomes, for which it uses a total number of events. Such illustrations depend on their assumptions and should not be interpreted as observed power. They do not supply a missing primary endpoint result, nor do they convert this single-group study into a randomized comparison. The registry record does not report a sample-size justification for the trial's own design.
What can be inferred from the listed analysis count?
The registry lists 19 outcome measures and one analysis. That information does not specify which outcomes were included in that analysis, how they were modeled, whether the analysis was prespecified, or how missing observations were handled. A count of analyses is not a substitute for a statistical analysis plan or a set of outcome estimates. Those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 19 outcome measures and one analysis. It does not report how the outcomes were prioritized beyond identifying the primary outcome, whether secondary outcomes were considered exploratory, or whether any adjustment for multiple testing was planned. When many outcomes are examined, the chance of obtaining at least one apparently notable result can increase. Multiplicity procedures can address that issue, but the appropriate approach depends on the study aims and analysis plan. No such procedure is reported in the registry record.
Missing data matter because the primary endpoint is defined as a percentage of patients assessed over a 48-hour period. If some participants have incomplete glucose measurements or incomplete follow-up for nausea or hypoglycemia, the choice of denominator and rules for classifying outcomes may affect the estimate. The registry record does not report whether there were missing observations, how missingness was defined, or how incomplete participant data were handled.
The analysis population is also not described in the registered information. It does not specify whether all enrolled participants were included in each analysis, whether any participants were excluded, or how deviations from the planned infusion were treated. These omissions limit the ability to assess whether reported estimates, if available elsewhere, correspond to all enrolled participants or a selected subset.
Because no primary estimate or detailed analysis plan is reported in the registry record, the robustness of the feasibility conclusion cannot be evaluated. The same limitation applies to interpretation of the secondary outcomes. These are reporting gaps, not proof that analyses or procedures were absent.
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 |
|---|---|---|---|
| Exenatide | 3 | 8 | 37.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Exenatide | 3 of 8 |
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 |
|---|---|
| Exenatide | 0 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | Exenatide |
|---|---|---|
| Death | Nervous system disorders | 3 of 8 |
Serious events with the highest arm-level rate: death (37.5%).
The registry records 3 serious adverse events among 8 at risk in the Exenatide group. It also lists 0 other adverse events among 8 at risk and records 3 deaths. Death is the listed serious adverse event term at 37.5%. These figures describe what the registry reports; they do not establish why the events occurred or whether they were caused by exenatide.
Serious adverse events and other adverse events are separate categories in the record. They should not be combined or interpreted as though they were necessarily assessed using identical definitions. The registry does not provide event-level descriptions, timing relative to infusion, severity details beyond the serious-event classification, or investigator attribution. It also does not report a comparator group against which to assess the counts.
The presence of deaths in this critically ill population requires careful contextual interpretation. A count alone cannot distinguish events related to the underlying brain injury or critical illness from events potentially related to study treatment. The registry information does not provide the clinical context or causal assessment needed to make that distinction. These numbers are therefore safety observations, not a comparative risk estimate.
12. What the Result Does, and Does Not, Mean
The record describes a feasibility study of intravenous exenatide in critically ill patients with acute brain injury, with glucose and safety criteria assessed over 48 hours from infusion initiation. Its primary question is whether a specified proportion of patients reached the glucose goal while remaining within stated limits for severe hypoglycemia and nausea requiring discontinuation. The registry record does not report the result for that primary endpoint.
Accordingly, the available registered information does not show whether the feasibility criteria were met. It does not establish the frequency of goal-range glucose measurements, the time needed to reach the range, the extent of glycemic variability, or the amount of insulin used. Although these outcomes are listed, their numerical results are not reported in the registry information.
The study's single-group design also limits what any descriptive findings could mean. Without a concurrent comparator, observed outcomes cannot establish what would have happened to similar patients under a different treatment or usual care. Nor can the design, on its own, isolate exenatide's contribution from other care or the clinical course of acute brain injury. This does not make the observations uninformative, but it restricts the claims they can support.
The adverse event counts are likewise descriptive. The record lists serious events and deaths but does not report enough contextual or comparative information to attribute them to treatment. The recorded enrollment is 8, so the study is small and any percentage estimate would be sensitive to individual outcomes. A precision estimate for the primary endpoint is not reported.
What the registry does establish is the study's stated purpose, its single-group Phase 4 design, its feasibility thresholds, its listed secondary outcomes, and the recorded safety counts. What it does not establish is whether exenatide achieved the target, how the results compare with another approach, or whether treatment caused the recorded events. Those distinctions are central to reading a feasibility study accurately.
13. Why This Trial Matters Statistically
This study is statistically notable for framing the primary question around feasibility rather than a randomized treatment comparison. Feasibility criteria can make practical objectives explicit: the registry identifies a glucose goal and limits concerning severe hypoglycemia and nausea requiring discontinuation. Such criteria are useful for defining what investigators intended to examine, even when the record does not include the result needed to judge whether the criteria were met.
The single-group design makes the distinction between description and comparison especially important. Observed percentages can characterize participants in the study, but they do not provide a randomized estimate of a treatment difference. The registry itself cautions against treating arms as a like-for-like control comparison, and the design lists no comparator. Statistical interpretation should therefore stay close to the feasibility and descriptive aims.
The study also highlights the difference between patient-level outcomes and repeated measurement outcomes. A percentage of patients meeting criteria is not the same as a percentage of glucose readings in range. Repeated measurements can provide detail about glucose patterns, but they need analysis that accounts for measurements being clustered within participants. The listed secondary outcomes span several distinct summaries, including medians, percentages, timing, variability, and insulin use.
Finally, the registry's missing primary result illustrates why transparent outcome reporting is essential. A stated threshold is not evidence that the threshold was achieved. Without the estimate, denominator, and uncertainty, readers cannot judge the result's magnitude or precision. Clear reporting of these elements would allow readers to distinguish a feasibility signal from a definitive comparative claim.
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 registry record does not report the primary endpoint result, its numerator and denominator, or a confidence interval. As a result, the central feasibility question cannot be evaluated from the registered information. Numerical results for the listed secondary glucose and insulin outcomes are also not reported.
The study enrolled 8 and used a single-group design. The small enrollment limits the precision that could be expected from descriptive percentages, while the lack of a concurrent comparator prevents a randomized treatment-effect estimate. The record gives no detailed eligibility criteria or participant characteristics, so the applicability of any observations to other patients cannot be assessed from the registry information.
Important operational details are not reported in the registry record, including exenatide dose and infusion schedule, glucose-measurement frequency, the exact rules for classifying the primary endpoint, and how participants with incomplete observation were handled. The record also does not provide a sample-size justification, interim-analysis information, or a full statistical plan. It is therefore not possible to assess whether the analysis followed a prespecified approach or how uncertainty was to be quantified.
The safety counts lack event-level context, timing, and attribution. With no comparison group, they cannot be used to estimate a relative safety difference or establish causation. Finally, the relationship between the listed 19 outcome measures and the recorded one analysis is not explained. Multiplicity handling and analysis populations are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intravenous Exenatide in Patients With Acute Brain Injury — NCT02058940.
- Registry record last updated 2018-07-12; status last verified 2017-09.
- Results first posted 2018-07-12.
- 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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18. Record Summary
NCT02058940 is a completed Phase 4, single-group study sponsored by the University of North Carolina, Chapel Hill. It assessed the feasibility of intravenous exenatide in critically ill patients with acute brain injury. Enrollment was 8; the recorded start was 2015-08 and primary completion was 2017-08.
The primary outcome was the percentage meeting feasibility criteria over 48 hours from infusion initiation, including a glucose goal range of 110-180 mg/dL and specified limits for severe hypoglycemia and nausea requiring discontinuation. Secondary outcomes addressed glucose levels and measurements, time to goal, glycemic variability, insulin use, and hypoglycemia.
The registry records 3 serious adverse events among 8 at risk, 0 other adverse events among 8 at risk, and 3 deaths; Death is listed as a serious event term at 37.5%. The primary endpoint result, detailed outcome estimates, and full statistical plan are not reported in the registry record.