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 The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients (NCT00798590), a randomized phase 2 study. The primary outcome is To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00798590 |
| Phase | Phase 2 |
| Condition | Critically Ill, Hypoglycemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johns Hopkins University |
| Results posted | Yes |
2. Clinical Question
Population
Critically ill patients, with the official title specifying critically ill surgical patients. The registry lists critically ill patients and hypoglycemia among the conditions.
Intervention
Glucagon-Like Peptide-1, also described in the record as GLP-1 (7-36) amide.
Comparator
Saline. The registry's outcome descriptions also use the term placebo.
Primary question
Whether the composite overall amount of insulin used with GLP-1 differs from that used with placebo to reach and maintain the ICU-specific target glucose range.
The proposed clinical question is about insulin requirements in an intensive care setting, rather than a direct comparison of blood glucose values alone. The brief summary describes examining GLP-1 to control blood glucose in critically ill patients. The primary outcome title specifies insulin use needed to reach and maintain a target glucose range, while a secondary outcome concerns the number of hypoglycemic events during GLP-1 or placebo treatment.
The registry does not give the target glucose range, a detailed definition of the composite measure, or a reported estimate comparing the treatment groups. It also states that outcome measure data, if collected, are unknown because no data are available. Consequently, the record identifies what investigators intended to ask but does not establish what the comparison found. It cannot show the size, direction, or precision of any difference in insulin use or hypoglycemic events.
3. Trial Design
The registry describes a phase 2, randomized, triple-masked, parallel-group trial of GLP-1 and saline. The listed enrollment is 19. That registry entry does not establish how many participants were ultimately assigned to treatment, received an intervention, or contributed outcome data; the study record says that outcome data are unavailable.
The interventions are listed as Glucagon-Like Peptide-1 and saline. The arm descriptions contain no additional details. Although the trial design is recorded as triple-masked, the registry record does not specify which groups of people were masked or how masking was maintained. The record also does not report the randomization procedure, allocation concealment, treatment dose, administration schedule, or other details needed to reconstruct the conduct of the comparison.
The recorded study start is 2008-12 and primary completion is 2010-06. The study status is terminated. The primary outcome timeframe is listed as 2 years. The registry attributes termination to the principal investigator leaving the institution and noncompliance with the Institutional Review Board. It states that the outcome data, if collected, are unknown because no data are available.
These design features describe the intended comparison, not evidence that the planned comparison was completed as designed. Random allocation and masking are design features that can help limit some sources of bias in general, but their presence in a registry entry does not substitute for information about implementation, participant flow, or analyzed outcomes. Those details are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | GLP-1 | Saline |
|---|---|---|
| STARTED | 11 | 8 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 11 | 8 |
Reasons for not completing this period:
| Reason | GLP-1 | Saline |
|---|---|---|
| P.I, Left institution. Study terminated | 11 | 8 |
Analysis population for the primary outcome, as defined in the registry: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.
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 | GLP-1 | Saline | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 8 | 19 | |
| Age, Customized: >=21 and <=75 | participants | 11 | 8 | 19 |
| Sex: Female, Male: Female | Participants | 1 | 5 | 6 |
| Sex: Female, Male: Male | Participants | 10 | 3 | 13 |
| Region of Enrollment: United States | participants | 11 | 8 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range., measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled as a comparison of the composite overall amount of insulin used with GLP-1 versus placebo to reach and maintain an ICU-specific target glucose range. In concept, insulin use can serve as a measure of treatment required to achieve a specified glucose-management goal. A composite that includes reaching and maintaining a target may be intended to capture more than a single measurement at a single time. This is a general explanation of the endpoint concept, not a description of results from this trial.
The registry does not define the composite's components, explain how insulin use was summarized, or state the target glucose range. It lists the timeframe as 2 years, but does not clarify how that timeframe relates to measurement occasions or the proposed period of treatment. The primary outcome information also says that the study was terminated and that outcome data, if collected, are unknown because no data are available. Therefore, the endpoint can be described from its title, but no group values, treatment contrast, or uncertainty interval can be reported.
Without a clear operational definition, readers cannot determine how the composite would handle changing insulin use over time or distinguish its components. Without outcome data, they cannot determine whether the groups differed on this measure. The endpoint states the intended clinical comparison; it does not supply an observed estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry records an intended randomized comparison but does not report outcome results. It says that the study was terminated because the principal investigator left the institution and the study was noncompliant with the Institutional Review Board. It further states that outcome measure data, if collected, are unknown because no data are available. Accordingly, there is no posted estimate of insulin use for either group and no reported between-group effect to interpret.
There is also no reported confidence interval, standard error, test statistic, or p-value for the primary outcome. The absence of these results means that neither the direction nor the magnitude of a possible treatment difference can be assessed. It also prevents an assessment of precision: a confidence interval, in general, describes a range of estimates compatible with the data and method used, but no such interval is reported for this comparison.
The listed enrollment is 19, but that entry should not be treated as evidence that 19 participants were analyzed or that the treatment groups had any particular size. The record does not provide a participant-flow account or analysis population. It does not say how many participants were randomized, treated, followed, or included in any analysis. No analyses are listed in the registry record.
The secondary outcome concerns comparing the number of hypoglycemic events between GLP-1 and placebo treatment. No event comparison or outcome data are reported. The adverse event fields list zero values for the GLP-1 and saline groups, but the same record lacks participant-at-risk counts and says that outcome data are unavailable. Those entries cannot be interpreted as evidence that no adverse events occurred or as a comparative safety result.
The record therefore supports conclusions about the planned question, design labels, enrollment entry, termination, and missing results. It does not support a conclusion that GLP-1 increased, decreased, or had no effect on insulin use, blood glucose control, or hypoglycemic events. A lack of posted results is not a finding of no difference. The registry record also does not explain whether any analyses were performed outside the registry or whether unreported outcome data exist elsewhere.
9. Statistical Methods Explained
What does randomization contribute? In general, randomization assigns participants to interventions through a chance-based process. When properly implemented, it can reduce systematic differences between groups at the start of a trial, so that a comparison is less vulnerable to confounding by measured or unmeasured baseline factors. The registry labels this trial randomized, but the sequence-generation method, allocation concealment, and assignment details are not reported in the registry record. The design label alone cannot establish how allocation was carried out.
What does masking mean? Masking is intended to limit the influence of knowledge about treatment assignment on care, reporting, or outcome assessment. The record labels the study triple-masked. It does not identify which people were masked, how masking was maintained, or whether it was successful. These details matter in general because expectations or differences in care can affect outcomes, particularly when outcome definitions involve clinical decisions or measurements over time.
How should the primary outcome be understood? The endpoint title refers to a composite overall amount of insulin used to reach and maintain an ICU-specific target glucose range. In general, an outcome that combines aspects of achieving and maintaining a target may represent a longitudinal treatment burden rather than a single point measurement. Interpretation depends on the exact definition, measurement schedule, and summary method. The registry does not give those details, nor does it state the target glucose range or how the composite was calculated. The recorded timeframe is 2 years, but the relationship between that timeframe and outcome measurement is not explained.
Why are estimates and uncertainty important? A treatment-effect estimate describes the observed contrast between groups under a defined analysis. A confidence interval communicates the uncertainty around that estimate under the statistical method used. A p-value, when reported, relates the observed data to a specified null model and does not by itself describe clinical importance or precision. These are general statistical concepts. The registry reports no primary-outcome estimate, confidence interval, p-value, or other inferential statistic, so none can be interpreted for this trial.
What can a sample-size illustration say? In general, a planning illustration based on an observed effect asks how many participants per arm might be needed under specified assumptions to detect an effect of a chosen fraction of that observed effect. It is not observed power and is not a description of the trial's original design. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The record also describes the effect to detect as a stated fraction of the observed effect. For time-to-event calculations, the stated convention is total events using the Schoenfeld method; other calculations are expressed as participants per arm. Since no observed primary-outcome effect is available in the registry record, such an illustration cannot supply evidence about this trial's treatment effect or replace missing outcome data. The record does not report the trial's own sample-size justification.
Why might over-dispersion matter in general? Counts of events can vary more than a simple statistical model assumes. Over-dispersion means that the observed variability is greater than the model's assumed variability; ignoring it can make uncertainty appear too small. This general issue can be relevant to event-count outcomes such as hypoglycemic events, depending on the data and model. The registry does not report the event data, analysis model, or any assessment of over-dispersion, so no claim can be made about whether it affected this trial.
What analysis details are absent? The registry lists no analyses. It does not report a statistical analysis plan, outcome-specific model, covariate adjustment, handling of repeated measurements, approach to multiple comparisons, or interim analyses. These methods cannot be inferred from the phase, masking, or randomization labels. Because outcome data are unavailable, recalculations from summary statistics are not possible, and there is no sponsor analysis in the registry record to compare with a recalculation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures. The primary outcome concerns the composite overall amount of insulin used to reach and maintain the ICU-specific target glucose range. The secondary outcome compares the number of hypoglycemic events between GLP-1 and placebo treatment. The record does not report results for either outcome, and it lists no analyses.
When a trial examines multiple outcomes or multiple comparisons, the chance of obtaining a seemingly notable result by chance can increase. Statistical methods can address multiplicity, but any adjustment or rationale for not adjusting should be described in the analysis plan or results. No multiplicity strategy is reported in the registry record. Because no test results are posted, there is also no basis for assessing how such a strategy would affect interpretation.
The record states that outcome data, if collected, are unknown because no data are available. It does not report whether data were collected, why any outcome data are unavailable, how missing observations were handled, or whether imputation was considered. The mechanism or extent of missingness cannot be characterized from this record.
The analysis populations are not reported in the registry record. There is no description of an intention-to-treat, per-protocol, or other analysis set, and no participant flow identifying assignment, treatment receipt, follow-up, or inclusion in analyses. The enrollment entry of 19 does not establish the size of an analyzed population. Without these details, neither the handling of missing data nor the population to which a treatment estimate would apply can be assessed.
11. What the Result Does, and Does Not, Mean
The registry record identifies a clinically focused research question: whether GLP-1, compared with saline or placebo, changes the insulin use needed to reach and maintain an ICU-specific target glucose range in critically ill patients. It also identifies hypoglycemic events as a secondary outcome. These are descriptions of intended outcomes, not reported findings.
The study status is terminated, and the record attributes this to the principal investigator leaving the institution and noncompliance with the Institutional Review Board. The primary outcome description explicitly says that outcome data, if collected, are unknown because no data are available. As a result, the record does not establish whether either intervention was associated with more or less insulin use, or whether the groups differed in hypoglycemic events.
This absence of results should not be interpreted as evidence that the interventions had the same effect. It is also not evidence that GLP-1 was beneficial or harmful. Without group outcomes and an uncertainty estimate, the size, direction, and precision of a comparative effect remain unknown. The adverse event entries with zero values do not resolve this uncertainty, because the record does not provide participant-at-risk counts and separately states that outcome data are unavailable.
The listed design and enrollment can help readers understand the intended study, but they cannot compensate for missing results. Nor can a planning illustration stand in for an observed treatment comparison. The registry record does not provide evidence to guide an efficacy or safety conclusion; it documents a terminated study with no available outcome results.
12. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a registered research question and an estimable treatment effect. A randomized, triple-masked design describes an intended approach to comparison, but statistical interpretation still depends on outcome data, transparent analysis methods, and clear reporting of who contributed to each analysis. Here, the registry identifies design features and an enrollment entry while also stating that outcome data are unavailable.
The primary measure is framed as a composite of insulin use to reach and maintain a target. Composite and longitudinal outcomes can require precise definitions: readers need to know which components contribute, how measurements are collected, and how those measurements are combined. The record does not provide this operational detail. This limits assessment of what the endpoint would represent even apart from the absence of results.
The secondary event-count outcome raises a separate general statistical issue. Counts may require methods suited to their distribution and variability, and over-dispersion can affect uncertainty when a model assumes less variation than the data contain. The record reports no event data or analysis method, so no method can be evaluated for this outcome.
Finally, the record shows why zero entries in adverse-event fields should not be read in isolation. With unavailable outcome data and no participant-at-risk counts, those values do not establish a safety profile. The most informative statistical conclusion is therefore about the limits of the available evidence: the treatment comparison cannot be estimated from the registry record.
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 principal limitation is that the registry explicitly states that outcome measure data, if collected, are unknown because no data are available. There is no reported primary or secondary outcome result, and the registry lists no analyses. This prevents estimation of a treatment contrast and assessment of its uncertainty.
The record gives limited detail about the endpoint. It does not define the components of the insulin-use composite, specify the ICU-specific target glucose range, explain the measurement schedule, or describe how the composite would be summarized. Although the timeframe is listed as 2 years, the record does not explain its relation to outcome measurement.
Participant-flow and analysis-population information are not reported. The enrollment entry of 19 does not show how many participants were randomized, received treatment, completed follow-up, or were analyzed, and no group-specific participant counts are available. The registry also does not report treatment dose or schedule, randomization procedures, allocation concealment, masking implementation, or a statistical analysis plan.
The study is recorded as terminated, with the stated reasons being the principal investigator's departure from the institution and noncompliance with the Institutional Review Board. The record does not explain whether data were collected before termination or why any collected data are unavailable. Adverse-event fields list zero values but do not include participant-at-risk counts, while the outcome description states that data are unavailable. These entries therefore do not permit a comparative safety assessment.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients — NCT00798590.
- Registry record last updated 2017-07-02; status last verified 2017-06.
- Results first posted 2017-07-02.
- 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
The registry describes a phase 2, randomized, triple-masked, parallel-group comparison of GLP-1 and saline in critically ill patients. The listed enrollment is 19. The primary outcome concerns the composite overall amount of insulin used to reach and maintain an ICU-specific target glucose range; the secondary outcome concerns hypoglycemic events.
The study is marked terminated. The record attributes termination to the principal investigator leaving the institution and noncompliance with the Institutional Review Board. It states that outcome data, if collected, are unknown because no data are available, and lists no analyses. Thus, the record describes the intended design and outcomes but does not provide results from which efficacy, event differences, or precision can be assessed.