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 Liraglutide in Adolescents With Type 1 Diabetes (NCT02516657), a na phase 3 study. The primary outcome is Mean Weekly Blood Glucose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02516657 |
| Phase | Phase 3 |
| Condition | Type 1 Diabetes |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University at Buffalo |
| Results posted | Yes |
2. Clinical Question
Population
Adolescents with type 1 diabetes were the population of interest. The registry record says five subjects enrolled, but mean weekly blood glucose data were collected for four because one subject had missing continuous glucose monitor data. Further eligibility details, including a specific age range, are not reported in the registry record.
Intervention
The intervention was liraglutide 0.6 mg by daily injection for seven days. The study description identifies the drug as a glucagon-like peptide-1 analog and frames the investigation around blood glucose, glucagon, and insulin-related measures in adolescents with type 1 diabetes.
Comparator
The primary outcome description compares Visit 1 before liraglutide at baseline, Day 0, with Visit 2 after liraglutide on Day 7. This is a within-group before-and-after reference, not a concurrent untreated or active-control group. A randomized comparison is not reported.
Primary question
The primary question was whether liraglutide decreased mean weekly blood glucose, measured in mg/dL from continuous glucose monitor readings, between baseline and Day 7. The registry record identifies this question but does not report the numerical outcome or an analysis result.
3. Trial Design
The registry record describes a Phase 3, single-group study of liraglutide in adolescents with type 1 diabetes. Allocation is listed as not applicable, and masking is listed as none. Five subjects enrolled. The study is marked completed, with a start date of 2012-05 and primary completion on 2022-08-03.
The intervention description specifies liraglutide 0.6 mg daily by injection for seven days. The primary outcome compares mean weekly blood glucose before treatment at baseline, Day 0, with the measure after treatment on Day 7. This structure gives a before-and-after comparison within the study group rather than a comparison between separately assigned groups. The registry record does not describe random assignment or masking.
The study summary also identifies post-meal blood glucose, glucagon levels, mean weekly blood sugars, and insulin doses as areas of interest. Total daily insulin dose is listed as a secondary outcome. Four outcome measures are recorded, but numerical outcome results and analysis results are not reported in the registry record. The specific protocol, recruitment details, eligibility criteria, adherence information, and reasons for the time between study start and primary completion are not reported in the registry record.
Because the design has no concurrent control group, changes between the two visits cannot by themselves separate an intervention-associated change from other changes over time. The record's completed status indicates the study's administrative status; it does not establish that every planned measure was available or that a statistical result was posted.
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 | Liraglutide 0.6 mg |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Data for mean weekly blood glucose was only collected for 4 of the 5 subjects enrolled in the study. 1 subject had missing CGM data
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: 5 adolescents with Type 1 diabetes for \> 1 year
| Characteristic | Unit | Liraglutide 0.6 mg |
|---|---|---|
| Participants analysed | 5 | |
| Age, Categorical: <=18 years | Participants | 5 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 2 |
| 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 | 0 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 5 |
| Hemoglobin A1c | Percent of glycosylated HemoglobinA | 8.52 (SD 0.64) |
| Total Daily insulin dose | Units per day | 73.74 (SD 10.09) |
6. Primary Endpoint
The registry lists the primary outcome as Mean Weekly Blood Glucose, measured over Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean weekly blood glucose, measured in mg/dL using continuous glucose monitor readings. The registry record describes it as a mean and specifies standard deviation as the measure of dispersion. It compares measurements at baseline, Day 0, before liraglutide, with measurements on Day 7, after liraglutide.
A mean condenses a set of measurements into a measure of its central level. For glucose readings collected over time, a weekly mean can describe the overall level across the measurement period rather than focusing on one isolated reading. Continuous monitoring can capture repeated readings across daily life; however, the registry record does not report the monitoring schedule, data-processing rules, or how much monitoring data were required for a weekly mean.
Standard deviation describes how spread out individual measurements are around a mean. It is not a measure of uncertainty in the estimated mean. A confidence interval, if reported, would address uncertainty in the estimated effect; no such interval is reported in the registry record.
The endpoint is relevant to the stated study question because the study summary focuses on blood glucose control. Still, an endpoint definition is not an outcome result. The numerical means, the change between visits, and their uncertainty are not reported in the registry record, so the direction and size of any observed change cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a specific primary outcome and two measurement occasions: baseline before liraglutide on Day 0 and after liraglutide on Day 7. It does not report the numerical mean weekly blood glucose at either visit, a change estimate, standard deviations, a confidence interval, or a p-value. The posted results therefore do not establish whether the measured mean increased, decreased, or remained similar.
The population note is important for interpreting the endpoint: mean weekly blood glucose was collected for four of the five enrolled subjects, while one subject had missing continuous glucose monitor data. The record does not state how the missing data were handled in an analysis, whether the four observed cases were analyzed as a paired set, or whether any additional outcome data were available. Without those details and the outcome values, the size and precision of a change cannot be judged.
The single-group before-and-after design limits causal interpretation. A difference between baseline and Day 7, if reported, would describe a change over time among the measured participants. Without a concurrent comparison group, the design cannot distinguish an intervention-associated change from other influences that may occur between visits. This is a general limitation of uncontrolled before-and-after comparisons, not evidence that any particular influence occurred in this study.
There is also no reported analysis result for the primary endpoint. The registry record lists zero analyses. This means there is no posted statistical test or estimate to interpret; it does not mean that the underlying measurements were identical, that no change occurred, or that a particular statistical conclusion was reached.
The enrollment of five subjects and the availability of glucose data for four make the reported outcome population small. In general, estimates from small groups can be sensitive to individual observations, and uncertainty can be substantial. However, the actual precision cannot be characterized without the estimates and variability statistics. No confidence interval or other uncertainty measure is reported in the registry record.
The correct reading is therefore limited: the registry record documents a planned primary comparison of mean weekly glucose before and after a seven-day liraglutide intervention, but it does not post the numerical result needed to determine the observed direction, magnitude, or precision. It also does not support a comparison with usual care or another treatment.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary outcome is a mean of continuous glucose monitor readings, expressed in mg/dL. A mean is a summary of the central level of a set of measurements. The standard deviation describes the spread of those measurements around the mean. These answer different questions: the mean describes the level, while the standard deviation describes variation among the readings or observations included in the summary.
Neither statistic alone shows how precisely an estimated treatment-related change is known. A confidence interval is a general statistical tool for expressing uncertainty around an estimate. Its width depends on factors such as variability and the amount of information available. No confidence interval or numerical variability result is reported in the registry record, so precision cannot be evaluated from the posted outcome information.
How should a before-and-after comparison be understood?
The primary endpoint compares baseline, Day 0, with Day 7 in a single group. In general, a before-and-after analysis may use the change for each participant, which accounts for the fact that the two measurements come from the same person. A method that treats the two time points as independent groups would not reflect that pairing. The registry record does not report which statistical method was used, whether the analysis was paired, or how the change was calculated.
A within-person comparison can describe whether measurements differ across the two visits, but it does not create a concurrent control. General changes over time, measurement conditions, or other influences could contribute to a difference. The study record does not report evidence that such influences did or did not affect this outcome. Without a control group, the comparison cannot isolate the effect of liraglutide from all other possible explanations.
What does the posted analysis information establish?
The registry record lists zero analyses and does not post a numerical result for the primary endpoint. Consequently, there is no reported estimate, standard error, confidence interval, or hypothesis-test result to interpret. A missing analysis entry is not itself a statistical finding: it cannot be read as evidence of no change, a positive result, or a negative result.
The record specifies that standard deviation is the dispersion measure, but does not provide its value. It also does not report the number of continuous glucose monitor readings contributing to each mean, the rules for excluding or processing readings, or any adjustment for baseline values. Those methodological details are not reported in the registry record.
What do the planning assumptions mean?
The registry record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes planning for a stated fraction of the observed effect and says that non-time-to-event illustrations are expressed as participants per arm. These are planning assumptions, not the design of the reported single-group study and not evidence about how many participants were actually analyzed.
A sample-size illustration asks how many participants might be needed under specified assumptions to detect a target effect with a chosen probability of statistical detection. It does not report the probability that this completed study detected an effect, and it is not observed power. The actual numerical planning results are not reported in the registry record. The observed effect needed to interpret such an illustration is also not reported with the primary outcome.
In general, over-dispersion means that observed variability exceeds what a chosen statistical model expects. If present, it can make standard errors and significance tests based on that model unreliable unless the analysis accounts for it. The registry record does not report an over-dispersion assessment or identify a model for the primary continuous endpoint, so no such issue can be attributed to this trial.
Overall, the endpoint definition and visit timing are described, but the statistical procedure and numerical analysis are not. General explanations of means, pairing, uncertainty, and planning assumptions clarify what the methods could mean; they do not fill in the missing analysis details.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures and identifies mean weekly blood glucose as the primary outcome. Total daily insulin dose is listed as a secondary outcome. The other outcome titles and their numerical results are not reported in the registry record. The record does not state whether formal hypothesis tests were planned for all outcomes, which outcomes were exploratory, or whether any multiplicity adjustment was applied.
Multiplicity arises when several outcomes or statistical tests are considered. In general, testing multiple hypotheses can increase the chance of at least one apparently notable result by chance. Methods such as adjusting significance thresholds or defining a hierarchy of outcomes can address this issue, but the registry record does not report a multiplicity strategy. No conclusion about whether adjustment was used is possible.
For the primary blood-glucose outcome, the registry record says data were collected for four of the five enrolled subjects because one subject had missing continuous glucose monitor data. It does not report the reason for the missing readings, whether the missingness was related to the observed or unobserved glucose values, or how the absent data were handled. It also does not report whether the person with missing data contributed to other outcomes.
Missingness matters because the analyzed participants may differ from those without usable measurements. General approaches can include analyzing available observations or using a specified imputation method, but the method used is not reported in the registry record. The analysis population, any exclusion rules, and whether all enrolled participants were included in each outcome analysis are also not reported. With no posted numerical outcome analysis, the impact of the missing CGM data cannot be assessed.
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 |
|---|---|---|---|
| Liraglutide 0.6 mg | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Liraglutide 0.6 mg | 0 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Liraglutide 0.6 mg | 0 of 5 |
For the liraglutide 0.6 mg group, the registry record lists five subjects at risk for serious adverse events and zero with a serious adverse event. It also lists five at risk for other adverse events and zero with an other adverse event. Deaths are listed as zero. These are the posted counts for the group; they should be read as event reporting within this small study, not as a precise estimate of risk.
A zero count in a group of five does not establish that an event is impossible or that risk is absent. With few participants, uncommon events may not appear during the observation period, and the record does not provide a basis for estimating their frequency with precision. No serious adverse event terms are listed.
The registry record does not report the adverse-event collection period, event definitions, severity grading procedures, or the method used to solicit and verify events. It also does not provide a concurrent comparison group. Therefore the counts cannot establish whether the intervention changed adverse-event risk relative to another treatment or to no treatment. They describe only the counts recorded for this group.
12. What the Result Does, and Does Not, Mean
The study addresses a defined statistical question: whether mean weekly blood glucose measured by continuous glucose monitoring differed between baseline before liraglutide and Day 7 after a seven-day intervention in adolescents with type 1 diabetes. The registry record describes liraglutide 0.6 mg by daily injection and identifies the intended outcome, its units, and its measurement occasions.
What the record does not establish is the numerical outcome. No mean values, change estimate, uncertainty interval, or analysis result are posted. It is therefore not possible to tell from the registry record whether blood glucose went up or down, how large any change was, or how precisely it was estimated. The absence of a reported result is not evidence that the intervention had no effect or that it did have an effect.
The study is single-group and unmasked, with no concurrent control group reported. In general, a before-and-after difference can reflect changes over time as well as intervention-associated changes. The design therefore cannot provide the same basis for causal comparison as a controlled randomized trial. The record does not report enough detail to assess whether other factors were addressed.
The glucose data were collected for four of five enrolled subjects, with missing continuous glucose monitor data for one subject. How that missingness was handled is not reported. The small number of observations and the absence of posted variability estimates mean that the precision of any possible change cannot be evaluated.
These limitations do not erase the study's value as a documented investigation. They define what can be concluded from its registry record: the study question, intervention, schedule, and recorded safety counts are described, while numerical efficacy results and key analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial matters statistically because its registry record illustrates the difference between a clearly stated research question and a reportable result. The record names mean weekly blood glucose as the primary endpoint, gives its measurement units, and specifies a baseline-to-Day 7 comparison. Those details make the intended estimand—the quantity the study seeks to describe—understandable at a broad level.
At the same time, no numerical outcome or analysis result is posted. Without the means, change estimate, and measures of uncertainty, readers cannot judge the direction, size, or precision of the observed result. A defined endpoint alone does not answer the research question. Transparent reporting of estimates and uncertainty is necessary for readers to evaluate the evidence.
The design also makes the comparison structure important. A single-group before-and-after study can describe temporal change among participants with measurements, but it lacks a concurrent group to help distinguish intervention-associated change from other influences. That distinction is especially relevant when interpreting a short follow-up comparison. The registry record does not establish which explanation accounts for any change because the change itself is not numerically reported.
The missing CGM data for one of the five enrolled subjects further highlights the importance of reporting analysis populations and missing-data handling. The record notes the missing data but does not describe the method used to address them. That information is needed to understand which participants contributed to the endpoint and how robust an estimate may be.
These features make the record useful for statistical appraisal: it states the question and design, while leaving the result and several analysis details unavailable. The appropriate interpretation is cautious and descriptive, not a claim for or against treatment benefit.
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.
Several limitations specific to this trial constrain interpretation. The registry record describes a single-group study with no masking and no randomized allocation. Its primary comparison is between baseline and Day 7, so there is no concurrent control group to separate intervention-associated change from other changes over time.
Only five subjects enrolled, and mean weekly blood glucose data were collected for four because one subject had missing continuous glucose monitor data. The record does not report how missing data were handled, whether the available observations formed a complete paired set, or whether the missing data could have affected the estimated outcome.
Most importantly, numerical results for the primary endpoint are not reported in the registry record. There are no posted means, change estimates, standard deviations, confidence intervals, or test results. The statistical method, analysis population, and outcome data-processing rules are also not reported. This prevents assessment of both effect magnitude and precision.
The intervention period is described as seven days, with measurements at baseline and Day 7. The registry record does not report longer-term outcome measurements or whether the recorded changes persisted. It also does not report further protocol details, eligibility criteria, adherence, or the rationale for the enrollment target. These absences limit assessment of design choices and applicability beyond the enrolled group.
Finally, the safety counts come from a small group, and event-collection procedures and observation duration are not described. The counts cannot support a precise estimate of uncommon events or a comparison of safety against another group.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Liraglutide in Adolescents With Type 1 Diabetes — NCT02516657.
- Registry record last updated 2025-04-20; status last verified 2025-04.
- Results first posted 2025-04-20.
- 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
NCT02516657 is a completed Phase 3, single-group study sponsored by the University at Buffalo. Five subjects enrolled. The registry lists a study start of 2012-05 and primary completion on 2022-08-03.
The study evaluated liraglutide 0.6 mg by daily injection for seven days in adolescents with type 1 diabetes. The primary outcome was mean weekly blood glucose in mg/dL from continuous glucose monitor readings, comparing baseline on Day 0 with Day 7. Data for this outcome were collected for four subjects; one subject had missing CGM data. Total daily insulin dose is listed as a secondary outcome.
The record lists zero analyses and does not report numerical results for the primary outcome. For the liraglutide group, it records zero serious adverse events among five at risk, zero other adverse events among five at risk, and zero deaths. The numerical outcome, its precision, and several analysis details are not reported in the registry record.