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 Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia (NCT01972152), a randomized phase 2 study. The primary outcome is Serious Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01972152 |
| Phase | Phase 2 |
| Condition | Hypoglycemia |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 30 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Xeris Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Healthy volunteers. The registry lists enrollment as 30, while the posted outcome analyses include group sizes that vary by measure. The study was not described as enrolling people experiencing severe hypoglycemia.
Intervention
A single 1 mg subcutaneous injection of G-Pen, or a single 0.5 mg subcutaneous injection of G-Pen.
Comparator
A single 1 mg subcutaneous injection of Lilly Glucagon, described in the registry as glucagon for injection of rDNA origin.
Primary question
How many serious adverse events were recorded in each treatment group from first dose through completion of the post-treatment follow-up visit, up to 6 weeks? Secondary measures addressed glucose responses and glucagon pharmacokinetics.
The registry describes the study purpose as evaluating safety, tolerability, and comparative pharmacokinetics and pharmacodynamics of G-Pen and Lilly Glucagon. Its brief summary also frames the comparison around safety and efficacy for treating severe hypoglycemia, a complication of diabetes. However, the registered participants were healthy volunteers, and the primary outcome reported was a count of serious adverse events, not a clinical treatment-success outcome in people experiencing severe hypoglycemia.
The secondary measures included glucose area under the curve, maximum glucose concentration, and time to maximum glucose concentration, as well as glucagon exposure measures. These outcomes characterize biochemical responses after injection. They address a different question from whether a treatment resolves severe hypoglycemia in the intended care setting. The registry record does not report a clinical outcome measuring resolution of a severe hypoglycemic event.
3. Trial Design
This was a randomized, phase 2, double-blind, three-way crossover study. The registry lists three treatment conditions: G-Pen 1 mg, G-Pen 0.5 mg, and Lilly Glucagon 1 mg. Each was described as a single subcutaneous injection. The study took place in healthy volunteers and was marked completed in the registry.
In general, a crossover design compares treatments within the same participants across different treatment periods. This can make within-person comparisons informative because each participant may serve as their own comparator. The particular treatment sequences, period structure, washout intervals, and approach to possible period or carryover effects are not reported in the registry record. Those details matter when judging how a crossover comparison was implemented and analyzed.
The registry identifies the study as randomized and double-blind, but does not report the randomization sequence or which parties were blinded. It lists enrollment as 30. The number included in posted analyses differs by outcome and treatment group: for example, the primary serious-adverse-event results include group sizes of 28, 29, and 28. The registry states that all subjects receiving treatment were included in the primary analysis. Reasons for differences between enrollment and analyzed group sizes are not reported in the registry record.
The primary outcome was the number of serious adverse events per treatment group from first dose until completion of the post-treatment follow-up visit, up to 6 weeks. Secondary outcomes addressed glucose responses and glucagon pharmacokinetics. The registry lists mixed models analysis for several secondary outcomes. Further model specifications, including how treatment period or participant-level correlation was handled, 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.
Before assignment: Of a total of 41 individuals recruited, 4 declined participation, 7 did not meet eligibility criteria and 30 were enrolled.
First Treatment Visit
| Stage | G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg | G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg | G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg | G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg | Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg | Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg |
|---|---|---|---|---|---|---|
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 4 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 1 | 0 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg | G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg | G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg | G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg | Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg | Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg |
|---|---|---|---|---|---|---|
| Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
Second Treatment Visit
| Stage | G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg | G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg | G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg | G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg | Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg | Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg |
|---|---|---|---|---|---|---|
| STARTED | 5 | 4 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 3 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 1 | 0 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg | G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg | G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg | G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg | Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg | Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg |
|---|---|---|---|---|---|---|
| Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 |
Third Treatment Visit
| Stage | G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg | G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg | G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg | G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg | Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg | Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg |
|---|---|---|---|---|---|---|
| STARTED | 5 | 3 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 3 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All subjects receiving treatment were included in this analysis.
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: The study involved a 3-way cross-over design with 30 total randomized subjects, so the baseline characteristics are the same for all 3 arms.
| Characteristic | Unit | Total Study Group |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 38.7 (SD 10.8) |
| Sex: Female, Male: Female | Participants | 21 |
| Sex: Female, Male: Male | Participants | 9 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 24 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 28 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 30 |
| Body Mass Index | kg/m^2 | 31.2 (SD 5.7) |
6. Primary Endpoint
The registry lists the primary outcome as Serious Adverse Events, measured over From first dose until completion of the post-treatment follow-up visit, up to 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of serious adverse events recorded in each treatment group. The registry defines the measure as a count of serious adverse events per treatment group, with observation beginning at the first dose and ending at completion of the post-treatment follow-up visit, up to 6 weeks. The primary analysis population is described as all subjects receiving treatment.
Serious adverse events are an important safety outcome because they capture events classified as serious during the specified observation period. A count provides a direct summary of the events recorded, but it does not by itself describe event type, severity beyond the serious classification, timing, or whether an event was judged related to treatment. The registry lists no top serious-event terms, and no serious events are recorded in any of the three treatment groups. The registry does not report an inferential comparison, confidence interval, or statistical test for this primary count outcome.
For a count endpoint, a comparative interpretation ordinarily depends on event frequency and the analysis approach, especially when events are uncommon. In this study, zero recorded serious adverse events in each group means the posted results do not distinguish the treatments on this measure. It does not establish that serious events cannot occur, or quantify how similar the treatments are for safety. The observation period and the treated participants included in each group define the scope of what the count can describe.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
No serious adverse events were recorded in any treatment group. The analyzed group sizes were 28 for G-Pen 1 mg, 29 for G-Pen 0.5 mg, and 28 for Lilly Glucagon 1 mg. These are descriptive counts over the registered follow-up period, not evidence that serious adverse events are impossible or that comparative safety has been established. No statistical comparison or uncertainty interval for the primary endpoint is reported in the registry record.
The posted secondary results describe glucose and glucagon measurements after injection. The registry reports mixed models analyses for selected comparisons or across treatment groups. For glucose area under the curve, the reported mixed-model p value across the three groups is 0.24. For glucose maximum concentration, reported mixed-model p values are 0.34 for G-Pen 1 mg versus Lilly Glucagon 1 mg and 0.01 for G-Pen 0.5 mg versus Lilly Glucagon 1 mg. For time to maximum glucose concentration, the reported mixed-model p value across the three groups is 0.95. These tests address secondary biochemical outcomes, not the primary serious-adverse-event count.
Unadjusted summary-statistic recalculations for some two-group comparisons produce estimates and confidence intervals that differ in purpose from the registry’s mixed-model analyses. For example, the recalculated mean difference in glucose area under the curve for G-Pen 0.5 mg versus G-Pen 1 mg is -14.1, with a 95% confidence interval from -43.98 to 15.78 and an unadjusted p value of 0.355. For G-Pen 1 mg versus Lilly Glucagon 1 mg, the recalculated difference is -7.6, with a 95% confidence interval from -44.12 to 28.92 and an unadjusted p value of 0.683. These are simple unadjusted recalculations from posted summary statistics; they are not replacements for the registry’s crossover-model results.
Confidence intervals express the uncertainty around an estimated contrast under the method used to calculate them. In general, an interval that spans zero is compatible with more than one direction of difference, so it does not establish equivalence. The registry record does not report an equivalence margin or a noninferiority margin. A p value alone also does not measure the size or clinical importance of a difference. The posted secondary findings therefore describe selected biochemical comparisons, but they do not establish that the treatments are equivalent, or determine performance in people being treated for severe hypoglycemia.
9. Statistical Methods Explained
The design is described as randomized, double-blind, and crossover. In general, randomization helps guard against systematic allocation differences, while blinding can limit expectations from influencing conduct or assessment. A crossover study gives participants different treatments in sequence, allowing comparisons that may use within-participant information. Interpretation depends on the sequence and timing of treatments and on how analyses account for repeated observations. The registry record does not report the treatment sequences, washout intervals, or detailed model structure for the crossover.
What does the primary count show?
The primary endpoint is a count of serious adverse events in each group during the stated follow-up. The posted count is zero for each treatment, with analyzed groups of 28, 29, and 28. A count can be easy to interpret descriptively, but a zero count does not show that the underlying event rate is zero. No confidence interval, hypothesis test, or model for this endpoint is reported in the registry record. The outcome is therefore best read as the events observed among treated participants during the specified period.
How should the secondary comparisons be read?
The registry lists mixed models analysis for several secondary outcomes. In general, mixed models can account for correlated observations, such as repeated measurements within a participant, and can include factors associated with the study design. The registry does not report the model terms, covariance assumptions, treatment sequence handling, or whether period and carryover effects were assessed. The reported p values should be interpreted as the registry’s stated results, without assuming details that are not documented.
Some two-arm estimates were recalculated from posted means, standard deviations, and group sizes. These are unadjusted summary-statistic comparisons. They do not incorporate the crossover structure as documented in the registry’s mixed-model analyses, and they should not be mistaken for the sponsor’s model-based estimates. The recalculated confidence intervals and p values provide a separate descriptive statistical view of selected comparisons. They do not replace the registered analysis.
In general, a mean difference summarizes the contrast between group means, while its confidence interval conveys uncertainty in that estimate. A p value describes how compatible the observed data are with a specified null hypothesis under the test’s assumptions; it is not the probability that the null hypothesis is true. Neither a nonsignificant p value nor an interval spanning zero demonstrates equivalence. A claim of equivalence requires a prespecified margin and an analysis designed to assess that margin, which are not reported in the registry record.
What do the planning illustrations mean?
The planning illustrations use the observed effect as a starting point, then consider detecting stated fractions of that effect. They assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning illustrations, not the trial’s design justification or its observed power. The registry record does not report the trial’s sample-size justification or its original power calculation. The illustrations also do not establish that the observed effects are stable estimates of effects expected in a future study.
In general, planning calculations based on an observed effect can be imprecise, particularly when the estimate comes from a small study. Smaller target effects require more information to detect than larger target effects, all else being equal. That conceptual point does not make a planning illustration a prediction of a future study’s outcome. The registry record does not report whether the original study had a target effect, a prespecified power, or an interim analysis.
What remains uncertain?
The registry does not report how missing observations were handled, whether analyses followed an intention-to-treat principle, or how many participants completed every treatment period. It does describe the primary analysis population as all subjects receiving treatment. The population and missing-data approach for the secondary outcomes are not reported in the registry record. These gaps limit assessment of how the posted results relate to all randomized participants and how robust the comparisons are to incomplete data.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes and reports several analyses across treatment groups or selected pairs. When many outcomes and comparisons are tested, the chance of at least one small p value arising by chance can increase. In general, a multiplicity procedure can control that issue, or a prespecified testing hierarchy can identify which comparisons are intended to carry confirmatory weight. Neither a multiplicity adjustment nor a hierarchy is reported in the registry record.
Consequently, individual secondary p values should be read as unadjusted unless the registry explicitly says otherwise. The registry does not report whether these tests were prespecified, whether they were exploratory, or how their interpretation should be prioritized. A small p value for one secondary comparison does not by itself establish a general treatment advantage, particularly when other outcomes address different features of response.
The primary analysis population is described as all subjects receiving treatment. The group sizes for the primary outcome are 28, 29, and 28. The registry does not explain why these group sizes differ from the listed enrollment of 30, and it does not report reasons for missing observations. Handling of missing data, exclusions after randomization, and the analysis population used for each secondary outcome are not reported in the registry record.
Those omissions are relevant because missingness can affect both the amount of information available and the interpretation of comparisons. In general, an analysis restricted to observed measurements can be biased if the likelihood of a missing measurement is related to the outcome or treatment response. The record does not provide enough detail to assess whether that concern arose or how it was addressed. It also does not report interim analyses or a statistical analysis plan.
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 |
|---|---|---|---|
| G-Pen(TM) 1 mg | 0 | 28 | 0.0% |
| G-Pen(TM) 0.5 mg | 0 | 29 | 0.0% |
| Lilly Glucagon(TM) 1 mg | 0 | 28 | 0.0% |
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 |
|---|---|
| G-Pen(TM) 1 mg | 22 of 28 |
| G-Pen(TM) 0.5 mg | 26 of 29 |
| Lilly Glucagon(TM) 1 mg | 22 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | G-Pen(TM) 1 mg | G-Pen(TM) 0.5 mg | Lilly Glucagon(TM) 1 mg |
|---|---|---|---|---|
| Injection Site Reaction | Skin and subcutaneous tissue disorders | 21 of 28 | 24 of 29 | 11 of 28 |
| Nausea | Gastrointestinal disorders | 5 of 28 | 4 of 29 | 13 of 28 |
| Headache | Nervous system disorders | 2 of 28 | 2 of 29 | 2 of 28 |
| Dizziness | Nervous system disorders | 1 of 28 | 1 of 29 | 2 of 28 |
| Hot Flushes | Endocrine disorders | 0 of 28 | 1 of 29 | 3 of 28 |
| Diarrhea | Gastrointestinal disorders | 1 of 28 | 2 of 29 | 0 of 28 |
| Flushing | Endocrine disorders | 1 of 28 | 0 of 29 | 2 of 28 |
| Gastrointestinal Pain | Gastrointestinal disorders | 1 of 28 | 0 of 29 | 2 of 28 |
The registry reports zero serious adverse events for G-Pen 1 mg, zero for G-Pen 0.5 mg, and zero for Lilly Glucagon 1 mg. The corresponding analyzed group sizes are 28, 29, and 28. These are event counts observed from first dose through completion of the post-treatment follow-up visit, up to 6 weeks. No top serious-event terms are listed.
Zero recorded events in these groups is a limited description of safety during the specified follow-up. It does not establish that the treatments have identical safety profiles or that serious events cannot occur. The registry does not report a comparative statistical analysis or uncertainty interval for the primary endpoint, and the count alone does not describe the possible range of event rates beyond the study.
The registry also lists other adverse events affecting 22 participants in the G-Pen 1 mg group, 26 in the G-Pen 0.5 mg group, and 22 in the Lilly Glucagon 1 mg group. These are separate from the serious adverse-event count. The record does not give further details about the types of those events in the registry record reported for this analysis. The death fields are not reported, so no conclusion about deaths should be drawn from those fields.
12. What the Result Does, and Does Not, Mean
The posted primary result is that no serious adverse events were recorded in any of the three treatment groups during the specified follow-up. This is a descriptive finding among treated participants included in the primary analysis. It does not establish equal safety, rule out uncommon events, or quantify comparative risk with a confidence interval. The registry reports no statistical test for this endpoint.
The study also reports secondary laboratory measures related to glucose response and glucagon pharmacokinetics. These measures can describe response patterns after injection, but they are not the same as demonstrating successful treatment of severe hypoglycemia in a person experiencing an episode. Participants were described as healthy volunteers, and the registry record does not report a clinical severe-hypoglycemia treatment outcome.
The crossover design and mixed-model analyses are relevant to interpreting the secondary results, but the registry’s public description does not provide all details needed to assess the model specification or handling of repeated measurements. Some unadjusted recalculations offer additional estimates for selected comparisons; they do not replace the registry’s model-based findings and should not be read as a definitive analysis of the crossover data.
The record does not report a prespecified equivalence or noninferiority margin. Therefore, findings that do not show a statistically notable difference cannot be interpreted as proof that the treatments are equivalent. Likewise, one secondary p value cannot establish a broad clinical conclusion, especially without information about multiplicity and the intended status of each secondary test. The results are best understood as observations from a completed phase 2 study in healthy volunteers, with a primary safety count and secondary biochemical measures.
13. Why This Trial Matters Statistically
This study illustrates why the trial design and the endpoint both matter when reading clinical results. A randomized crossover study can support comparisons of treatments within participants, but the analysis needs to account appropriately for the repeated-treatment structure. The registry identifies mixed models for several secondary analyses, while leaving the model details and treatment-period handling unreported. That distinction cautions against treating simple two-group recalculations as interchangeable with the registered analysis.
The primary endpoint is a safety count, while the secondary outcomes describe glucose and glucagon measurements. Those outcomes answer different statistical and clinical questions. A zero count of serious adverse events is directly interpretable as an observation, but it gives limited information about uncertainty or comparative safety without an interval or model. Biochemical differences, in turn, do not directly establish clinical treatment success in severe hypoglycemia.
The study also shows why a nonsignificant result is not the same as equivalence. Equivalence requires a defined margin and a suitable analysis, neither of which is reported in the registry record. Similarly, multiple secondary analyses require care in interpretation when no multiplicity approach is reported. Considering the design, endpoint, analysis, and uncertainty together gives a more accurate reading than focusing on any single p value.
Finally, planning calculations based on observed effects can help illustrate the information future comparisons might require, but they are not observed power and do not reveal the original design rationale. Their value is as planning context, not as evidence that the treatments differ or are interchangeable.
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 study population was healthy volunteers, whereas severe hypoglycemia is the condition named in the registry summary. The record does not report a clinical outcome measuring treatment of an actual severe hypoglycemic episode. This limits how directly the posted biochemical measurements can address treatment performance in the intended clinical situation.
The primary serious-adverse-event endpoint has zero events in every group, and the registry does not provide a comparative estimate or confidence interval for that count. The result therefore gives little precision about differences in uncommon serious events. Other adverse events are reported as counts of affected participants, but the listed details do not include their types or further characterization.
Although the study is identified as a three-way crossover, the treatment sequences, period structure, washout intervals, and assessment of carryover are not reported in the registry record. The details of the mixed models are also not reported. These omissions make it difficult to evaluate how the analysis accounted for within-participant comparisons and potential period-related influences.
The registry does not report missing-data methods, reasons for the varying analyzed group sizes, or a secondary-outcome analysis population. Multiplicity handling and any prespecified hierarchy for secondary tests are also not reported. No equivalence or noninferiority margin is listed. These limitations constrain claims about precision, confirmatory evidence, and comparability, while leaving the descriptive posted results available for interpretation within their stated scope.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia — NCT01972152.
- Registry record last updated 2016-02-03; status last verified 2016-01.
- Results first posted 2016-02-03.
- 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
The registry describes NCT01972152 as a completed, randomized, double-blind, phase 2, three-way crossover study sponsored by Xeris Pharmaceuticals. It compared single subcutaneous injections of G-Pen 1 mg, G-Pen 0.5 mg, and Lilly Glucagon 1 mg in healthy volunteers. Enrollment is listed as 30.
The primary outcome was the number of serious adverse events from first dose through post-treatment follow-up, up to 6 weeks. The posted count is zero for each group. Secondary outcomes include glucose response and glucagon pharmacokinetic measures, with mixed models analyses reported for selected results. Details of the model specification, missing-data handling, multiplicity approach, and treatment sequence are not reported in the registry record.