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 Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection (NCT03167411), a randomized phase 1 study. The primary outcome is Cmax (Maximum Observed Plasma Concentration).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03167411 |
| Phase | Phase 1 |
| Condition | Type2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Theracos |
| Results posted | Yes |
2. Clinical Question
Population
The study record describes a trial in healthy subjects. It lists an enrollment of 20 and a condition of Type2 Diabetes Mellitus; how that condition listing relates to the healthy-subject description is not reported in the registry record. The primary outcome population was defined as subjects in the pharmacokinetic population with data.
Intervention
The intervention of interest was bexagliflozin administered with exenatide injection. The record describes the study purpose as evaluating a drug-drug interaction, while also assessing safety and tolerability. Details of the administration schedule beyond the reported endpoint sampling description are not reported in the registry record.
Comparator
The comparator was bexagliflozin alone. The two reported treatment groups are titled “Bexagliflozin” and “Bexagliflozin With Exenatide.” Because the study used a crossover model, the treatment comparison concerns outcomes under the two treatment conditions; the sequence and period details are not reported in the registry record.
Primary question
The primary question was whether coadministration of exenatide was associated with a different maximum observed plasma concentration of bexagliflozin, or Cmax, compared with bexagliflozin alone. The record reports geometric means for each treatment and a point estimate with a 90% confidence interval for the comparison. It does not report a prespecified equivalence margin.
This is a pharmacokinetic question, not a direct test of clinical benefit. Cmax describes the highest observed plasma concentration after dosing, and the trial’s stated focus was the interaction between the two drugs. The record also lists urinary glucose excretion as a secondary outcome, but its value is not reported in the registry record. The available comparison therefore addresses the posted Cmax result and does not establish how other outcomes behaved.
3. Trial Design
This was a phase 1, randomized, open-label, two-period, two-treatment crossover study. It was marked completed and had an enrollment of 20. The study started on 2017-05-24, with primary completion on 2017-06-29. Theracos is listed as the sponsor. Its official title describes an evaluation of exenatide’s effect on the pharmacokinetics and pharmacodynamics of bexagliflozin in healthy subjects.
In a crossover design, participants receive different treatment conditions over separate periods, so comparisons can use within-participant information when those data are available and analyzed accordingly. This general design feature can reduce the influence of stable differences between participants. It does not remove the need to consider period, sequence, or carryover effects. The treatment sequence, period duration, washout details, and handling of possible carryover are not reported in the registry record, so their role in the analysis cannot be assessed from the posted information.
The study was randomized and had no masking. The record lists two treatment conditions: bexagliflozin alone and bexagliflozin with exenatide injection. The primary outcome population was the number of subjects in the pharmacokinetic population with data. The posted Cmax summaries include 19 participants for bexagliflozin alone and 17 for the combination condition. These outcome-specific counts differ from the enrollment total; reasons for the missing outcome data are not reported in the registry record.
The brief summary says the study was intended to examine the drug-drug interaction and to evaluate safety and tolerability. The registry lists five outcome measures, one secondary outcome name, and two analyses. Beyond the descriptions posted for the primary endpoint and the listed secondary outcome, further protocol 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 | Bexagliflozin, Then Bexagliflozin With Exenatide | Bexagliflozin With Exenatide, Then Bexagliflozin Alone |
|---|---|---|
| STARTED | 10 | 10 |
| COMPLETED | 10 | 9 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Bexagliflozin, Then Bexagliflozin With Exenatide | Bexagliflozin With Exenatide, Then Bexagliflozin Alone |
|---|---|---|
| Adverse Event | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Number of subjects in the PK population with 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.
| Characteristic | Unit | Bexagliflozin, Then Bexagliflozin With Exenatide | Bexagliflozin With Exenatide, Then Bexagliflozin | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 10 | 20 | |
| Age, Continuous | years | 35.0 (SD 9.03) | 43.1 (SD 14.79) | 39.1 (SD 12.63) |
| Sex: Female, Male: Female | Participants | 5 | 5 | 10 |
| Sex: Female, Male: Male | Participants | 5 | 5 | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 | 10 | 19 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 6 | 7 |
| Race (NIH/OMB): White | Participants | 6 | 4 | 10 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Weight | kg | 77.6 (SD 10.48) | 80.7 (SD 17.29) | 79.1 (SD 14.01) |
| Height | cm | 173.1 (SD 9.66) | 170.8 (SD 10.94) | 172.0 (SD 10.11) |
| BMI | kg/m^2 | 25.9 (SD 3.45) | 27.3 (SD 3.14) | 26.6 (SD 3.29) |
| Systolic Blood Pressure | mm Hg | 109.1 (SD 11.98) | 106.3 (SD 8.11) | 107.7 (SD 10.06) |
6. Primary Endpoint
The registry lists the primary outcome as Cmax (Maximum Observed Plasma Concentration), measured over Up to 48 hrs.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | ng/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was Cmax, the maximum observed plasma concentration of bexagliflozin, measured in ng/mL. The record says whole venous blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h after bexagliflozin dosing in each period. Cmax was selected directly from the experimental observations, while other pharmacokinetic parameters were calculated using non-compartmental pharmacokinetic analysis. The stated timeframe was up to 48 hrs.
Cmax is used in pharmacokinetic studies because it captures the peak concentration observed after a dose. Comparing it under the two treatment conditions can help describe whether coadministration is associated with a change in peak exposure. It does not by itself describe the full concentration-time profile, total exposure, duration of exposure, or a clinical outcome. Those questions require other measures or evidence.
The treatment-specific Cmax summaries are geometric means, with geometric coefficients of variation as the reported dispersion measure. The bexagliflozin-alone group had a geometric mean of 95.9 ng/mL and a geometric coefficient of variation of 33.6; the combination group had a geometric mean of 121.6 ng/mL and a geometric coefficient of variation of 33.1. The registry also reports a point estimate and 90% confidence interval for the comparison. The clinical meaning of that estimate depends on a prespecified decision criterion, and such a margin is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted treatment-specific geometric means are 95.9 ng/mL for bexagliflozin alone and 121.6 ng/mL for bexagliflozin with exenatide. The associated geometric coefficients of variation are 33.6 and 33.1, respectively. These summaries describe the observed Cmax distributions using geometric-scale measures; they do not show every participant’s values or the shape of the underlying data. The PK population counts were 19 and 17, respectively.
The registry reports a comparison point estimate of 125.27%, with a 90% confidence interval from 104.45% to 150.24%. The estimate is a relative comparison expressed as a percentage, rather than an absolute concentration difference. Its confidence interval conveys uncertainty about the comparison under the analysis used. The interval extends across a range of possible relative estimates, so the point estimate alone should not be treated as the only plausible value. The reported interval does not establish whether the result meets an equivalence or no-effect criterion because the registry record does not report the relevant prespecified margin or decision rule.
The comparison is labeled as an equivalence analysis in the registry. That label identifies the analysis type but is not, by itself, evidence that equivalence was demonstrated. Equivalence conclusions ordinarily depend on whether the confidence interval satisfies prespecified bounds. Those bounds and any formal conclusion are not reported in the registry record. No p-value is posted for this comparison, and the result should not be reframed as a conventional test of whether a difference is statistically significant.
The study’s randomized crossover structure is suited to comparing treatment conditions within a trial, but important analytic details are unavailable. The registry record does not report the treatment sequences, period effects, carryover assessment, model specification, or a detailed analysis population definition beyond the PK-population description. These omissions limit assessment of how the reported estimate was derived and whether the model accounted for design features.
The record presents one primary Cmax comparison and lists urinary glucose excretion as a secondary outcome. Although five outcome measures and two analyses are noted, the other endpoint values are not reported in the registry record. Thus, the available result is narrow: it describes the posted Cmax summaries and comparison in the observed pharmacokinetic population. It does not supply a complete account of all measured outcomes, nor does it support a broader conclusion about safety, tolerability, pharmacodynamics, or clinical effects.
9. Statistical Methods Explained
General statistical explanation: a crossover study assigns treatment conditions in a sequence, with each participant receiving more than one condition in separate periods. When analyzed appropriately, the design can compare measurements within the same participant, which can account for stable participant characteristics. The registry identifies this study as randomized and crossover, but does not report the treatment sequences, period details, washout, or model used. It is therefore not possible to determine from the registry record how the analysis handled period or carryover considerations.
What does a geometric mean describe?
The posted Cmax summaries use geometric means. General statistical explanation: geometric means are useful for measurements that are positive and may be skewed, because they summarize values on a multiplicative scale. They are calculated by transforming observations to a logarithmic scale, averaging there, and transforming back. This general description explains the measure; the specific transformation and analysis implementation are not reported in the registry record.
The reported geometric coefficients of variation describe relative variability on a geometric scale. They are not standard deviations in the original concentration units. The Cmax summaries are 95.9 ng/mL with a geometric coefficient of variation of 33.6 for bexagliflozin alone, and 121.6 ng/mL with a geometric coefficient of variation of 33.1 for bexagliflozin with exenatide. These measures summarize the treatment groups but do not reveal individual values, outliers, or the full distribution.
How should the comparison estimate be read?
The comparison is reported as a point estimate of 125.27%, with a 90% confidence interval from 104.45% to 150.24%. General statistical explanation: a confidence interval gives a range of values compatible with the data and analysis under the method’s assumptions. It expresses uncertainty around an estimate; it is not a range containing a stated proportion of individual participants’ results. A wider interval indicates less precision than a narrower interval on the same scale. The exact confidence-interval method is not reported in the registry record.
Because the estimate is reported as a percentage, it is interpreted on a relative scale rather than as a concentration in ng/mL. The registry labels the comparison as an equivalence analysis. General statistical explanation: an equivalence analysis evaluates whether an estimated difference or ratio is sufficiently close to a reference value according to prespecified bounds. The confidence interval is assessed against those bounds; the analysis label alone does not establish equivalence. The bounds and the formal decision are not reported in the registry record.
What does the endpoint sampling contribute?
The primary measure was the maximum observed concentration, selected from samples collected through the stated 48-hour period. Sampling at multiple times helps identify the observed peak within that schedule, although the peak’s precision depends in part on how the sampling times align with the concentration profile. General statistical explanation: a measured maximum is based on observed samples and may not coincide exactly with the true peak between sample times. The registry description says Cmax was obtained directly from experimental observations, while non-compartmental analysis was used to calculate pharmacokinetic parameters. It does not report the concentration-time data or individual Cmax values.
What can the sample-size illustrations say?
The sample-size material is a planning illustration computed from the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It considers effects defined as fractions of the observed effect. General statistical explanation: such calculations explore the sample size that might be needed for a future design under stated assumptions. They do not represent the study’s observed power and do not show that the original trial had a particular power. The registry record does not report a sample-size justification for the trial’s own design, and the planning illustrations should not be read as one.
General statistical explanation: over-dispersion occurs when data vary more than a statistical model assumes. If present, it can make uncertainty estimates too small unless the analysis accounts for it. The record reports geometric coefficients of variation, but does not report a model diagnostic or a specific assessment of over-dispersion. No conclusion about over-dispersion can be drawn from the posted summaries alone.
The number of participants with primary outcome data differs across treatment conditions: 19 for bexagliflozin alone and 17 for the combination condition. In a crossover study, the available data for a treatment condition can differ if observations are missing or unusable. General statistical explanation: missingness can affect estimates if the likelihood of having an observed outcome is related to the outcome or treatment response. Reasons for missing observations, the analysis approach to incomplete data, and sensitivity analyses are not reported in the registry record.
The record reports two analyses but does not specify their models or how they relate to the multiple listed outcomes. General statistical explanation: when several outcomes or comparisons are tested, multiplicity can increase the chance of a false-positive result across the set of tests. Statistical plans may address this through prespecified hierarchies or adjustment procedures. Such plans and procedures are not reported in the registry record. The posted Cmax estimate and interval should therefore be interpreted as the stated result for that comparison, without assuming an unreported multiplicity strategy.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Point Estimate (%) 125.27 | 104.45 to 150.24 | not reported |
The registry reports the comparison estimate as 125.27%, with a 90% confidence interval from 104.45% to 150.24%, and labels the analysis as equivalence. These are the sponsor analysis figures posted in the registry record. The treatment-level summaries provide context for the comparison: the geometric mean Cmax was 95.9 ng/mL with bexagliflozin alone and 121.6 ng/mL with bexagliflozin and exenatide.
No separate unadjusted recalculation of the comparison is reported in the registry record. A direct numerical comparison between a sponsor analysis and an independent recalculation therefore cannot be described from this record. The analysis method is also not specified, so the reported interval’s precise construction cannot be independently assessed from the posted information.
The record does not flag a discrepancy. The presence of an equivalence label should not be mistaken for a stated conclusion that equivalence was established: the prespecified equivalence bounds and the sponsor’s decision against those bounds are not reported in the registry record. The posted estimate and interval describe the reported result, while the missing decision criteria limit interpretation of whether it met a formal equivalence objective.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and two analyses, but names only urinary glucose excretion as a secondary outcome in addition to the primary Cmax outcome described in detail. Values for outcomes not posted are not reported in the registry record. The record does not identify a hierarchy for testing outcomes, a family of primary comparisons, or an adjustment for multiple testing. Consequently, it is not possible to assess whether multiplicity was anticipated or how it was handled.
General statistical explanation: when several outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. A prespecified testing hierarchy or multiplicity adjustment can help control that issue. Without a reported statistical analysis plan or adjustment method, the listed analysis count alone does not establish how the risk was addressed. The available Cmax estimate should be understood as the posted result for that endpoint, not as evidence of a broader testing strategy.
The primary outcome population is described as the number of subjects in the PK population with data. The outcome summaries include 19 participants for bexagliflozin alone and 17 for bexagliflozin with exenatide. The total enrollment was 20. Reasons that outcome data were absent or not estimable are not reported in the registry record. The record does not describe the analysis population beyond the brief PK-population definition, the handling of incomplete crossover observations, or sensitivity analyses for missing data.
General statistical explanation: missing outcome data can affect both the estimated treatment comparison and its precision. The degree of concern depends on why data are missing and whether missingness is related to treatment or outcomes. Without reasons, participant flow, and details of the missing-data approach, the direction or size of any effect cannot be inferred. The registry record also does not report interim analyses or a complete statistical analysis plan, so those aspects cannot be evaluated.
12. 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 |
|---|---|---|---|
| Bexagliflozin | 0 | 20 | 0.0% |
| Bexagliflozin With Exenatide | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bexagliflozin | 0 of 20 |
| Bexagliflozin With Exenatide | 0 of 20 |
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 |
|---|---|
| Bexagliflozin | 4 of 20 |
| Bexagliflozin With Exenatide | 10 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bexagliflozin | Bexagliflozin With Exenatide |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 1 of 20 | 7 of 20 |
| Vomiting | Gastrointestinal disorders | 1 of 20 | 4 of 20 |
| Headache | Nervous system disorders | 2 of 20 | 1 of 20 |
| Pollakiuria | Renal and urinary disorders | 2 of 20 | 1 of 20 |
| Abdominal pain | Gastrointestinal disorders | 0 of 20 | 1 of 20 |
| Asthenia | General disorders | 1 of 20 | 0 of 20 |
| Fatigue | General disorders | 0 of 20 | 1 of 20 |
| Laceration | Injury, poisoning and procedural complications | 0 of 20 | 1 of 20 |
| Dizziness | Nervous system disorders | 0 of 20 | 1 of 20 |
| Paresthesia | Nervous system disorders | 0 of 20 | 1 of 20 |
The adverse-event record lists 20 participants at risk in each treatment group. No serious adverse events were recorded in either group, and deaths were zero in both groups. The record lists four participants with other adverse events in the bexagliflozin group and 10 in the bexagliflozin-with-exenatide group. These are counts as posted; the registry does not provide further detail in the serious-event terms list.
These figures should be read as descriptive observations from a small phase 1 study, not as a definitive comparison of safety. The record does not provide event types for the other adverse events, their timing, severity, duration, relatedness assessments, or participant-level details. It also does not report a statistical comparison for these counts. The absence of a recorded serious adverse event in this study does not establish that serious events cannot occur.
The study summary states that safety and tolerability were evaluated, but the posted serious-event counts alone do not describe all aspects of safety or tolerability. They are separate from the primary pharmacokinetic endpoint, Cmax. No medical or treatment conclusion follows from these event counts alone.
13. What the Result Does, and Does Not, Mean
The result describes the observed maximum plasma concentration of bexagliflozin under two treatment conditions in a phase 1 crossover study. The registry reports geometric mean Cmax values of 95.9 ng/mL for bexagliflozin alone and 121.6 ng/mL for bexagliflozin with exenatide. The posted relative comparison estimate is 125.27%, with a 90% confidence interval from 104.45% to 150.24%. These estimates are based on the participants included in the PK summaries: 19 and 17, respectively.
The interval communicates uncertainty around the relative estimate, but the registry does not provide the prespecified equivalence bounds needed to judge the result against an equivalence criterion. The analysis is labeled equivalence, yet that label alone does not establish that an equivalence objective was met. The specific statistical model and analysis details are also not reported. These limits matter when interpreting what the reported estimate can establish.
The result does not describe all pharmacokinetic features. Cmax captures the observed peak, not the whole concentration-time profile or total exposure. Nor does it answer whether there were changes in clinical outcomes. Urinary glucose excretion is listed as a secondary outcome, but its result is not reported in the registry record. The posted data therefore do not provide a complete account of the trial’s stated pharmacodynamic or secondary outcome questions.
The safety data show zero serious adverse events and zero deaths in both groups, alongside counts of other adverse events. Those observations are descriptive and do not establish a comprehensive safety profile. The trial’s enrollment and outcome-specific counts, along with the lack of event details, constrain the inferences that can be drawn.
Overall, the registry supports a focused description of the Cmax summaries and reported comparison. It does not support claims about clinical benefit, a complete safety conclusion, or equivalence under an unstated margin. The protocol details and analysis plan needed to assess several of these questions are not reported in the registry record.
14. Why This Trial Matters Statistically
This study is statistically useful as an example of how a pharmacokinetic interaction question can be framed around a measured concentration endpoint. Cmax is an observed peak, while the comparison is presented on a relative scale with a confidence interval. Keeping those scales distinct helps prevent confusion between a concentration in ng/mL and a percentage-based comparison estimate.
The crossover design is also important to interpretation. General statistical explanation: crossover trials can make within-participant treatment comparisons possible, which can reduce variability due to stable differences between participants. Their validity still depends on design and analysis details such as treatment sequence, period effects, and carryover. The registry identifies the crossover model but does not report those details, illustrating why a design label is not a substitute for a full analysis description.
The result also illustrates the distinction between an analysis label and a statistical conclusion. The comparison is labeled equivalence, but interpreting equivalence requires prespecified bounds and a decision based on the interval. Those bounds and the formal conclusion are not reported in the registry record. An estimate and confidence interval remain informative descriptions, but cannot by themselves answer a question whose decision criterion is unavailable.
Finally, the difference between enrollment and treatment-specific PK counts highlights the importance of analysis populations and missing-data reporting. The registry gives the counts used for the primary summaries but does not explain the missing observations or analysis handling. For clinical researchers and biostatisticians, these gaps identify which parts of a trial result are transparent and which require further documentation before broader interpretation.
15. 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 provides limited detail on the crossover implementation. It identifies randomization, open-label masking, and a two-period, two-treatment crossover model, but does not report treatment sequences, period duration, washout, or how possible carryover was assessed. The analysis model and its treatment of period or sequence are also not reported, limiting evaluation of whether the analysis reflected the design.
The primary endpoint summaries are available, but participant-level data and the concentration-time profile are not reported. The PK population counts differ between treatment conditions, and reasons for absent or unusable data are not reported in the registry record. The missing-data approach, sensitivity analyses, and detailed definition of the PK population are not described. These omissions limit assessment of the robustness of the estimate.
The registry labels the comparison as equivalence but does not report equivalence bounds or a formal conclusion against those bounds. The method used to construct the 90% confidence interval is not specified. No separate unadjusted recalculation is reported in the registry record, so the posted analysis cannot be compared with an independent recalculation using the information available.
Outcome reporting is also incomplete for interpretation. Urinary glucose excretion is listed as a secondary outcome, but its result is not reported in the registry record. Although five outcome measures and two analyses are noted, the remaining details and any multiplicity plan are not reported. Safety reporting gives counts for other adverse events but not event types, severity, timing, or relatedness. These specific gaps constrain conclusions about pharmacodynamics, safety, and the totality of outcomes.
The record describes healthy subjects in the official title while listing Type2 Diabetes Mellitus as a condition. The relationship between those descriptions is not reported in the registry record. It also does not report a sample-size justification for the original trial, interim analyses, or a complete statistical analysis plan. Planning illustrations based on the observed effect do not resolve those omissions or represent observed power.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection — NCT03167411.
- Registry record last updated 2021-05-28; status last verified 2021-03.
- Results first posted 2021-05-28.
- 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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19. Record Summary
NCT03167411 is a completed phase 1, randomized, open-label, two-period, two-treatment crossover study sponsored by Theracos. It enrolled 20 participants and compared bexagliflozin alone with bexagliflozin administered with exenatide injection. The official title describes an evaluation of exenatide’s effect on bexagliflozin pharmacokinetics and pharmacodynamics in healthy subjects.
The primary outcome was Cmax, measured up to 48 hrs. The posted geometric means were 95.9 ng/mL for bexagliflozin alone and 121.6 ng/mL for the combination condition. The reported comparison estimate was 125.27%, with a 90% confidence interval from 104.45% to 150.24%, and was labeled as an equivalence analysis. The record does not report equivalence bounds or a formal conclusion against them.
Urinary glucose excretion is listed as a secondary outcome, but its result is not reported in the registry record. No serious adverse events or deaths were recorded; counts of other adverse events were four and 10 in the two groups. Several design, analysis, missing-data, and outcome-reporting details are not reported in the registry record.