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 A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes (NCT04585776), a na phase 2 study. The primary outcome is Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04585776 |
| Phase | Phase 2 |
| Condition | Type 1 Diabetes |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with type 1 diabetes were enrolled. The registry defines the primary-outcome population more narrowly as participants who received at least one dose of study drug and had post-baseline sensor glucose values. The number who met that outcome-specific definition is not reported in the registry record.
Intervention
The study regimen combined LY900014, a prandial insulin, with insulin degludec, a basal insulin. LY900014 was described as 100 units/milliliter and administered subcutaneously 0-2 minutes before meals. Insulin degludec was described as 100 U/mL and administered subcutaneously once daily. Individual insulin doses were adjusted during a 35-day titration period.
Comparator
There was no separate comparator group in this single-group study. The registry records allocation as not applicable and masking as none. The regimen therefore was not evaluated against a like-for-like control group in this trial.
Primary question
The primary endpoint is the mean percentage of time on Day 46 that sensor glucose values, measured by continuous glucose monitoring, were within the inclusive range of 70 to 180 mg/dL. The endpoint result itself is not reported in the registry record.
In statistical terms, the registry describes an exploratory measurement question: what was the average proportion of monitored time within the specified glucose range for the defined study population at the stated assessment time? It does not describe a randomized treatment-effect question comparing the combination regimen with another regimen. Without a comparator and without a reported endpoint estimate, the record cannot show a between-group difference or quantify how the observed value relates to another treatment or to participants’ values before treatment.
The registry lists 31 participants enrolled. That enrollment count does not establish how many contributed data to the primary endpoint, because the analysis population also required at least one dose and post-baseline sensor glucose values. That endpoint-specific count is not reported in the registry record.
3. Trial Design
This was a Phase 2, completed, single-group study sponsored by Eli Lilly and Company. The registry lists 31 participants with type 1 diabetes. The study start date is 2020-10-30, and the primary completion date is 2021-05-27. The registry records no masking and allocation as not applicable. These features describe a study without a randomized control arm; they do not support a like-for-like comparison between separate treatment groups.
Participants received LY900014 and insulin degludec together. LY900014 was described as a prandial insulin administered subcutaneously 0-2 minutes before meals, while insulin degludec was described as a once-daily basal insulin administered subcutaneously. Both are listed at a concentration of 100 units/milliliter or 100 U/mL, respectively. The registry states that participants received individually adjusted insulin doses during a 35-day titration period. Further details of the titration target are not reported in the registry record.
The primary endpoint was assessed on Day 46 and is defined as the mean percentage of time with sensor glucose values from 70 to 180 mg/dL, inclusive, using continuous glucose monitoring. The primary-outcome population is described as participants who received at least one dose and had post-baseline sensor glucose values. The number of participants included in that analysis is not reported in the registry record.
The registry names insulin-to-carbohydrate ratio, the ratio of prandial dose to total daily insulin dose, and the product of insulin-to-carbohydrate ratio and total daily dose as secondary outcomes. It lists four outcome measures overall, but the additional measure beyond the named secondary outcomes is not described in the record. No outcome analyses are listed. A detailed statistical analysis plan, a sample-size justification for the actual study, and the planned handling of interim analyses 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 | LY900014 + Insulin Degludec |
|---|---|
| STARTED | 31 |
| Received Atleast 1 Dose of Study Drug | 31 |
| COMPLETED | 31 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one dose of study drug and had post-baseline sensor glucose values.
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: All enrolled participants.
| Characteristic | Unit | LY900014 + Insulin Degludec |
|---|---|---|
| Participants analysed | 31 | |
| Age, Continuous | years | 42.20 (SD 13.75) |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 30 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| 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 | 1 |
| Race (NIH/OMB): White | Participants | 30 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM), measured over Day 46.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of time |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean percentage of time on Day 46 during which continuous glucose monitoring recorded sensor glucose values between 70 and 180 mg/dL, with both boundaries included. It expresses time in a specified target range as a percentage rather than as a single glucose reading. The registry identifies the endpoint as a continuous measure and specifies the mean and standard deviation as its summary statistics.
As a general statistical point, a time-in-range measure condenses repeated sensor readings over a monitoring period into an interpretable summary: the proportion of monitored time falling within a defined interval. It is used because a summary over time can describe glucose patterns that an isolated reading would not capture. The measure is tied to its stated range, monitoring method, assessment time, and analysis population; changing any of those definitions could change what the summary represents.
The registry specifies Day 46 as the timeframe, but it does not report the observed mean, standard deviation, number of participants contributing to this outcome, or a confidence interval. Those endpoint results are not reported in the registry record. The definition alone therefore explains what was intended to be measured, not what value participants experienced.
The endpoint is a descriptive outcome in this single-group study. Without a concurrent comparator and a reported result, it cannot quantify a treatment difference. Nor does the endpoint definition by itself establish how much sensor data each participant contributed or how missing sensor readings were handled; those details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the study’s design and defines the primary outcome, but it does not report the primary endpoint estimate. In particular, the mean percentage of time in the 70 to 180 mg/dL range on Day 46 and its standard deviation are not reported in the registry record. No confidence interval, p value, or analysis result is listed. Consequently, the record does not permit a numerical description of the observed time in range or of the precision of that estimate.
The absence of a comparator is central to interpretation. This is a single-group study with allocation recorded as not applicable and masking recorded as none. The primary endpoint therefore describes an outcome under the study regimen, if an outcome value is available; it is not a randomized estimate of the difference between the regimen and another treatment. Any change from a prior value would also require a reported baseline measure and an analysis of change, neither of which is specified in the primary outcome information summarized by the registry.
The registry records 31 participants enrolled. The primary population, however, is limited to those who received at least one dose and had post-baseline sensor glucose values. The number meeting that condition is not reported in the registry record, so enrollment should not be treated as the endpoint analysis size. The distinction matters because the precision of a mean depends partly on how many observations contribute and on their variability. Those outcome-specific details are not available in the record.
General interpretation of a continuous outcome commonly considers both the estimate and its uncertainty. A standard deviation describes dispersion among observed values; it is not the same as a confidence interval for the mean. A confidence interval, when reported, conveys a range of values compatible with the data and the analysis assumptions. Neither the dispersion nor an interval estimate is reported for this endpoint, so precision cannot be assessed from the registry entry.
The study is labeled exploratory in its official title. That designation is consistent with a focused measurement question, but the registry does not report a formal hypothesis test or a complete statistical analysis plan. It lists no outcome analyses. This means the available entry should not be read as evidence of statistical significance or as a complete account of how the collected data were analyzed.
The registry does report zero participants affected by a serious adverse event, zero affected by other adverse events in the listed group, and zero deaths. These are safety counts in the registry record, not substitutes for the missing primary endpoint result. They are also counts for the reported study group and should be interpreted within the study’s size and reporting scope, rather than as a comparison of safety between treatments.
Planning illustrations based on an observed effect are conceptually distinct from trial results and from the study’s actual design. The stated planning assumptions describe a hypothetical two-arm calculation, whereas this study was single-group. Such an illustration cannot establish that the actual study was designed with a particular power, and it is not observed power. A sample-size justification for this trial is not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary outcome as continuous and specifies the mean and standard deviation. Those choices describe how the outcome is intended to be summarized: the mean locates the center of the observed participant-level values, while the standard deviation describes their spread. The actual mean and standard deviation for Day 46 are not reported in the registry record, so these definitions do not yield an observed result.
What does the mean represent?
As a general statistical explanation, a mean combines the values in an analysis population into one average. For this endpoint, the underlying participant-level measure is a percentage of monitored time within the glucose range. An average across participants would characterize the group’s central outcome, but it would not show how similar or different participants’ values were. The registry does not report the endpoint mean or the number of participants contributing to it.
The standard deviation is a measure of variability among observed values. A larger spread indicates that participant-level percentages are more dispersed around the mean; a smaller spread indicates more concentration around it. This is general interpretation, not a description of variability observed in this study, because the standard deviation is not reported in the registry record.
How should uncertainty be understood?
In general, a confidence interval describes uncertainty around an estimated quantity under the assumptions of the analysis. For a mean, it reflects both the observed variability and the amount of information contributing to the estimate. A narrow interval indicates greater precision under those assumptions, while a wide interval indicates less precision. No confidence interval is reported for the primary outcome, so the precision of the Day 46 mean cannot be evaluated from this record.
A p value is a measure used in a specified hypothesis-testing framework; it is not a measure of effect size or clinical importance. The registry lists no analyses and reports no p value for the primary endpoint. There is therefore no reported inferential test to interpret. A statistical conclusion should not be inferred from the endpoint definition or from the study’s Phase 2 designation.
What does the design allow?
General statistical interpretation depends on design as well as on the outcome measure. A randomized comparison can, subject to its assumptions and conduct, estimate differences between allocated groups. This study is recorded as single-group, with allocation not applicable and masking none. The registry therefore describes no randomized between-group contrast. The endpoint can be understood as a planned summary for the treated study group, but the record does not report a numerical summary or a comparator-based estimate.
Open-label conduct means masking was not used, according to the registry. For an outcome based on sensor glucose readings, the recorded values are device measurements, but that fact does not remove all possible influences on study conduct, data availability, participant behavior, or analysis. The record does not describe those processes in enough detail to assess them. No further assumptions about their effects can be made from the registry entry.
How do the planning assumptions differ from trial results?
The registry’s planning assumptions describe an illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrated effect to detect is expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the planning convention is participants per arm. These assumptions describe a hypothetical planning exercise, not the actual single-group design, and do not establish the study’s original sample-size rationale.
Planning sample sizes are prospective illustrations of how a design might be sized under stated assumptions. They are not observed results and must not be described as observed power. In this case, the registry does not report a sample-size justification for the actual study, and it lists no outcome analyses. The observed endpoint effect needed to anchor the stated planning illustration is not reported in the registry record. Thus the assumptions alone cannot be used to infer what effect was observed or whether the trial had adequate precision.
General statistical planning also depends on the target comparison, outcome variability, analysis method, and assumptions about usable data. The registry does not report a complete protocol-level statistical plan, a justification for its enrollment, or details of any interim analyses. The planning illustration’s two-arm assumptions should not be mistaken for evidence that the trial itself had two arms or equal allocation.
Why can over-dispersion matter?
As a general concept, over-dispersion occurs when observed variability exceeds what a chosen statistical model assumes. If a model understates variability, uncertainty estimates can be too small and inferential conclusions can appear more precise than warranted. Conversely, a model that accounts for extra variability can yield more realistic uncertainty. The registry does not report a model-based analysis of the primary outcome or any assessment of over-dispersion, so this concept is relevant only as general statistical context, not as a finding about this trial.
The outcome is described as a percentage of time, which is bounded by its definition. General analyses of bounded measures may need to consider the distribution and the way observations are formed, especially if values cluster near the limits or differ in the amount of underlying monitoring data. The registry does not report the distribution of participant-level values, monitoring completeness, or an analysis method beyond identifying the mean and standard deviation as the summary measures. No distributional assumptions should therefore be attributed to the trial beyond what is recorded.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three secondary outcome types: insulin-to-carbohydrate ratio, the ratio of prandial dose to total daily insulin dose, and the product of insulin-to-carbohydrate ratio and total daily dose. It lists four outcome measures overall, but does not identify the remaining measure in the record. No outcome analyses are listed. A statistical plan describing how multiple outcomes or multiple tests were handled is not reported in the registry record.
As a general statistical matter, testing multiple outcomes can increase the chance that at least one result appears noteworthy by chance if each test is interpreted without accounting for the family of tests. A prespecified approach to multiplicity can clarify which outcomes are confirmatory and how inference is controlled. The registry entry does not state whether any such adjustment or hierarchy was planned, so no particular multiplicity method can be attributed to this study.
The primary-outcome population includes participants who received at least one dose and had post-baseline sensor glucose values. The registry does not report how many participants met that definition, whether all enrolled participants contributed, or how missing sensor measurements or incomplete monitoring were handled. It also does not describe imputation, exclusion rules beyond the stated population definition, or sensitivity analyses for missing data. These details are not reported in the registry record.
As general context, missing outcome data can affect both the number of observations available and the interpretation of an estimate, particularly if data availability is related to participant outcomes. The direction and size of any such effect cannot be inferred without information about missingness and the analysis method. The enrollment count of 31 should therefore not be assumed to be the number analyzed for the primary endpoint.
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 |
|---|---|---|---|
| LY900014 + Insulin Degludec | 0 | 31 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| LY900014 + Insulin Degludec | 0 of 31 |
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 |
|---|---|
| LY900014 + Insulin Degludec | 0 of 31 |
For the LY900014 plus insulin degludec group, the registry records 31 participants at risk for serious adverse events and 0 affected. It also records 31 participants at risk for other adverse events and 0 affected. The death count is 0. No serious adverse-event terms are listed.
These figures are counts in the registry record for the one reported study group. They do not provide a comparison with a control group, because the study is single-group and has no separate comparator. The counts also do not describe event rates over a stated person-time denominator; no such measure is reported in the registry record.
As a general statistical point, a zero count in a study group means that the listed events were not recorded among the participants counted for that category. It does not establish that an event is impossible or that the underlying risk is zero. The size of the study and the follow-up and event definitions affect how much can be inferred from a zero count. Further details about adverse-event definitions, collection procedures, and follow-up duration for these safety counts are not reported in the registry record.
The safety counts should be read separately from the primary glucose endpoint. They do not establish the value of time in range, and the missing endpoint result cannot be recovered from the adverse-event information.
12. What the Result Does, and Does Not, Mean
The registry record defines an exploratory study of LY900014 and insulin degludec in participants with type 1 diabetes. It specifies a Day 46 continuous glucose-monitoring outcome: the mean percentage of time with sensor glucose values from 70 to 180 mg/dL, inclusive. It also records an enrollment of 31 participants and describes dose adjustment during a 35-day titration period.
What the record does not report is the observed primary endpoint value. The mean, standard deviation, endpoint-specific participant count, confidence interval, and p value are not reported in the registry record. The entry therefore does not support a quantitative statement about the study group’s Day 46 time in range or the precision of that estimate.
The design also sets a clear boundary on interpretation. This was a single-group study with no randomized comparator. Even if a group-level outcome were reported, the design would not by itself estimate a randomized difference against another treatment. The registry does not report a baseline comparison or an analysis of change that could be used to describe a before-and-after effect.
The record does show zero participants affected by serious adverse events, zero affected by other adverse events in the listed group, and zero deaths. These are the reported safety counts, not evidence from a controlled safety comparison. Their meaning is limited to the events and participants represented in the registry record.
In general, an endpoint definition, an observed estimate, and a treatment-effect estimate answer different questions. A definition states what was measured; an estimate describes the measured data; a comparative estimate describes a contrast between groups or conditions. The registry provides the first, but does not report the second or a randomized comparative estimate. No conclusion about comparative effectiveness or comparative safety follows from the available information.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how a clearly defined continuous endpoint can still leave important interpretive questions unanswered when results and analysis details are not reported. The registry specifies the measurement concept, target range, assessment time, summary measure, and population definition for the primary outcome. Those details help identify what the planned endpoint represents.
At the same time, the endpoint’s observed mean and standard deviation are not reported in the registry record, and no analysis is listed. Without an estimate and an indication of its uncertainty, readers cannot judge the observed level of the outcome or its precision. This distinction is important: a well-defined endpoint is not itself a result.
The study also illustrates the role of design in the questions that can be answered. A single-group study can describe outcomes within its study group, but it does not supply a randomized contrast with a separate treatment group. The record marks allocation as not applicable and masking as none. Those design features should remain explicit when interpreting any reported outcome.
Finally, the registry’s planning assumptions refer to an illustrative two-arm calculation, while the actual study is recorded as single-group. Keeping planning illustrations separate from the trial’s design and observed findings prevents a hypothetical calculation from being mistaken for a protocol justification or evidence of achieved power. The actual sample-size justification and detailed statistical plan are not reported in the registry record.
These distinctions—measurement definition, design, estimation, uncertainty, and planning—are central to sound interpretation of clinical trial statistics. In this case, the record supports a precise description of the intended primary measure and study structure, but not a numerical account of the primary result.
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 primary limitation for statistical interpretation is that the registry does not report the Day 46 outcome estimate. The mean and standard deviation are not reported in the registry record, and no confidence interval or p value is listed. Without these results, neither the observed level of the endpoint nor its precision can be assessed.
The study is single-group, with allocation recorded as not applicable and masking as none. There is no like-for-like control comparison in the registry record, so a treatment contrast cannot be estimated from the design as described. The record also does not report a baseline endpoint value or a change-from-baseline analysis.
The registry lists 31 participants enrolled, but the primary analysis population requires at least one dose and post-baseline sensor glucose values. The number meeting those criteria is not reported in the registry record. The number of participants analyzed should not be assumed to equal enrollment.
Further outcome-analysis details are also absent. The registry does not report how missing or incomplete sensor data were handled, the distribution of participant-level endpoint values, or sensitivity analyses. A complete statistical analysis plan, the rationale for the actual sample size, and any interim-analysis details are not reported in the registry record. The record lists three secondary outcome types and four outcome measures overall, but does not describe all four or list analyses.
The listed safety counts are limited to the reported study group and do not constitute a controlled comparison. The registry entry does not give additional detail about adverse-event definitions or collection procedures. These limitations do not change the recorded study design or endpoint definition, but they restrict conclusions about outcome magnitude, precision, missing-data effects, and comparative treatment effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes — NCT04585776.
- Registry record last updated 2022-06-03; status last verified 2022-05.
- Results first posted 2022-06-03.
- 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 a completed Phase 2, single-group study of LY900014 plus insulin degludec in participants with type 1 diabetes. It records 31 participants enrolled, no masking, and allocation as not applicable. Individual doses were adjusted during a 35-day titration period.
The primary outcome is the mean percentage of time on Day 46 with continuous glucose-monitoring values between 70 and 180 mg/dL, inclusive. The primary population is defined as participants who received at least one dose and had post-baseline sensor glucose values. The observed endpoint result and the number analyzed are not reported in the registry record.
The registry lists three secondary outcome types and records zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths. No outcome analyses are listed. A detailed statistical analysis plan and the sample-size justification for the actual study are not reported in the registry record.