Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes (NCT01009580), a randomized phase 3 study. The primary outcome is Change in Glycosylated Haemoglobin (HbA1c).

2. Clinical Question

This question concerns a comparison of the groups' average change in a continuous laboratory measure. It is not a comparison of the proportion of participants who reached a particular target: such a target or responder analysis is not reported in the registry record. The analysis population was described as the full analysis set, with missing data imputed using last observation carried forward. One participant was randomized in error and removed from that analysis set.

The clinical interpretation is bounded by the posted outcome and follow-up period. The primary result addresses mean HbA1c change over 26 weeks; it does not by itself describe longer-term outcomes, individual responses, or every aspect of treatment safety. The registry record does not report a broader clinical endpoint that would replace this measure.

3. Trial Design

This was a phase 3, randomized, open-label, two-arm, parallel-group trial. The registry records enrollment of 447 and a completed status. The trial started on 2009-11-05, and primary completion was recorded as 2010-08-23. The planned treatment and primary endpoint period was 26 weeks.

The groups received IDegAsp twice daily or BIAsp 30 twice daily. The official title describes participants as having inadequate glycaemic control on once- or twice-daily premixed or self-mixed insulin, with or without oral antidiabetic drugs. It also describes background use of metformin, a DPP-4 inhibitor, or pioglitazone as optional. The registry does not provide further arm-level detail about background treatment in the arm descriptions.

Random allocation supports a comparison between groups by reducing systematic differences at assignment, although the method used to generate or conceal the allocation is not reported in the registry record. Masking was listed as none, so the trial was open-label. The record describes a parallel design, in which participants were assigned to one of the treatment groups rather than crossing between them.

The primary endpoint analysis used the full analysis set. Its description says that the set included all randomized subjects, with missing data imputed using last observation carried forward, except that one subject randomized in error was removed. The posted primary group sizes are 224 for IDegAsp and 222 for BIAsp 30. The registry's enrollment figure and analysis-set description are distinct record entries and should not be treated as interchangeable counts.

The registry record does not report the original sample-size justification, a prespecified analysis plan, interim analyses, or further details of allocation procedures. The posted outcome results therefore allow interpretation of the reported estimates, but do not establish all the design and analysis choices made before the trial began.

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: Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) of metformin, pioglitazone and DPP-4 inhibitor.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS.

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Glycosylated Haemoglobin (HbA1c), measured over Week 0, Week 26.

The primary endpoint is change in glycosylated haemoglobin, or HbA1c, from baseline at Week 0 to Week 26. It is reported as a mean change, with standard deviation as the measure of spread. The stated unit is percentage of glycosylated haemoglobin. The endpoint description specifies change from baseline after 26 weeks of treatment.

As a continuous measure, HbA1c can be summarized by the group mean while retaining information about the magnitude and direction of change. A mean change below the baseline value indicates an average reduction over the measurement period; the posted means are -1.28 for IDegAsp and -1.3 for BIAsp 30. The difference between group means is the main comparative quantity, rather than either group's change considered alone.

HbA1c is used in this trial as a measure of glycaemic control. A group average does not show how changes were distributed among individuals, whether each participant improved, or how many reached any particular threshold. Those questions require other summaries or endpoints. The registry record does not report a primary responder threshold.

The analysis description says missing endpoint data were handled using last observation carried forward. This method substitutes the participant's last available observation for a missing later value. It allows an analysis to include participants without a recorded Week 26 value, but it relies on assumptions about how an individual's outcome would have changed after the last measurement. The registry record does not report alternative missing-data analyses for this primary endpoint.

7. Results Posted in the Registry

• BIAsp 30 BID: mean -1.30 versus -1.28 on control; difference -0.02 (95% CI -0.20 to 0.16), standardized effect d = -0.02; z-test p = 0.825.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • BIAsp 30 BID: mean 7.30 versus 7.00 on control; difference 0.30 (95% CI -0.06 to 0.66), standardized effect d = 0.16; z-test p = 0.099.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between BIAsp 30 BID and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists three secondary outcomes: the mean of the 9-point Self Measured Plasma Glucose Profile, the rate of confirmed hypoglycaemic episodes, and the rate of nocturnal confirmed hypoglycaemic episodes. Numerical results are posted for the glucose profile outcome. Results for the two hypoglycaemia rate outcomes are not reported in the registry record, so a complete numerical pattern across all listed secondary endpoints cannot be assessed.

The posted glucose-profile comparison is a mean difference of 0.3 mmol/L for BIAsp 30 relative to IDegAsp, with an unadjusted p-value of 0.099. Its reported interval extends across the no-difference point, so the estimate does not provide a precise separation between the groups. This is a different measure from the primary HbA1c outcome and should be interpreted on its own scale and at its stated Week 26 time point.

The secondary result does not replace or independently confirm the primary comparison. HbA1c and the glucose profile summarize different aspects of glycaemic measurement, and agreement or disagreement between them would not by itself establish a broader treatment effect. The primary endpoint remains the stated main outcome for this trial; the secondary outcomes provide additional, but incomplete, information in the registry record.

Unadjusted secondary results generally carry less evidential weight when several outcomes are examined, because multiple opportunities for apparently notable results can arise by chance. A multiplicity adjustment or prespecified hierarchy can address this concern, but a plan of that kind is not reported in the registry record. No adjusted secondary p-values or reported analyses for the hypoglycaemia rates are available. Accordingly, the secondary findings are best treated as supportive descriptive evidence rather than as stand-alone confirmation.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
• Rate of Confirmed Hypoglycaemic Episodes
• Rate of Nocturnal Confirmed Hypoglycaemic Episodes

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, so the registry reports each group's mean change and standard deviation, followed by a mean difference between groups. These summaries answer related but different questions: the mean describes the average change within a group, while the mean difference estimates how far apart the group averages are. The standard deviation describes variation among the observations around a group mean; it is not the uncertainty of the mean difference itself.

What does the mean difference represent?

The reported contrast is -0.02, with the comparison expressed as IDegAsp minus BIAsp 30. A negative value means that the estimated mean change was numerically lower in the first group under that subtraction order. Since both posted group means are negative, the contrast is a comparison of changes, not a statement that one group had no change. Keeping the subtraction order clear is important when interpreting the sign of any continuous-outcome estimate.

A mean difference condenses the comparison into the original outcome scale. Unlike a standardized effect, it remains interpretable in the endpoint's units, which are percentage of glycosylated haemoglobin. It does not reveal the full distribution of participant-level changes. Two groups can have similar means while differing in spread or in the pattern of individual outcomes; the registry's mean and standard deviation summaries alone do not describe every such feature.

How should the interval and p-value be read?

A confidence interval expresses uncertainty around an estimated quantity: intervals that include values on both sides of the no-difference point indicate that the data are compatible with more than one direction of group contrast. The posted primary interval runs from -0.197 to 0.157. The registry record does not state the confidence level used for the interval, so no confidence level should be inferred from the record alone.

The unadjusted p-value is 0.825. A p-value describes how unusual data at least as incompatible with a specified null model would be under that model and the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not quantify the size or clinical importance of a difference. The word “unadjusted” matters because the record does not indicate that this value accounts for testing multiple outcomes or comparisons.

What does randomization contribute?

Randomization is intended to make the assigned groups comparable, on average, with respect to both measured and unmeasured baseline factors. It gives the between-group contrast a stronger basis for causal interpretation than an unrandomized comparison, provided that trial conduct and analysis preserve the assigned comparison appropriately. The registry record identifies randomized allocation but does not report the sequence-generation or concealment procedures.

The trial was open-label, with masking listed as none. Participants and trial personnel therefore were not masked to assignment according to the registry entry. Lack of masking may influence behavior or aspects of care even when an outcome is measured by a laboratory method. The record does not describe whether the outcome assessors or statisticians were separately masked.

What does the analysis population mean?

The full analysis set is described as including all randomized subjects, with missing data imputed by last observation carried forward. The description also notes that one subject randomized in error was removed from the set. The reported primary groups contain 224 and 222 participants. These are the analysis counts attached to the posted endpoint, not a new estimate of enrollment.

Last observation carried forward fills a missing later measurement with the participant's last observed value. This can preserve participants in the analysis, but it assumes that the last recorded value is a reasonable stand-in for the unobserved later outcome. If outcomes tend to change after the last measurement, that assumption may not hold. The registry record does not report sensitivity analyses that test how conclusions change under other missing-data assumptions, or the extent of missingness at Week 26.

Why does over-dispersion matter in general?

For a continuous outcome, dispersion describes how much individual measurements vary around the mean. Greater variation makes a group mean less precise when other aspects of the design remain similar, because observations provide less consistent information about the average. This general point helps explain why sample-size planning depends not only on the effect a study aims to detect but also on the variability of the outcome. In this trial, the reported standard deviations are 0.94 for IDegAsp and 0.97 for BIAsp 30.

Over-dispersion is especially relevant to count outcomes, where observed variation can exceed what a simple count model assumes. The secondary outcomes include rates of confirmed and nocturnal confirmed hypoglycaemic episodes, but numerical rate results and their statistical models are not reported in the registry record. No conclusion about over-dispersion in those outcomes can be drawn from the posted primary continuous-outcome summary.

What statistical details remain unavailable?

The registry record does not report the original trial sample-size calculation or its assumptions, the planned primary statistical model, covariate adjustment, a multiplicity strategy, interim analyses, or a detailed analysis plan. These absences limit assessment of whether the posted analysis matches all prespecified choices. The available comparison is interpretable as a reported group mean difference with an interval and unadjusted p-value, but those entries do not reveal the complete statistical workflow.

11. Confidence Intervals and Precision

The primary estimate is a mean difference of -0.02. Its reported interval extends from -0.197 to 0.157. Because the interval includes values on both sides of the no-difference point, it does not isolate a single direction of difference. The estimate itself is close to that point, but the interval is the more informative description of the range of values compatible with the reported analysis.

Precision concerns how narrowly an estimate is determined by the data and analysis. A relatively broad interval leaves more uncertainty about the size and direction of the underlying contrast than a narrow interval would. The posted interval should not be read as a range containing every possible true value, nor as a probability statement about this particular result. Its formal confidence level is not reported in the registry record.

The group standard deviations were 0.94 and 0.97, indicating variation in individual changes around the respective means. The standard deviations are not confidence intervals and should not be substituted for the uncertainty around the between-group estimate. The reported interval for the contrast is the relevant summary for judging its statistical precision.

The unadjusted p-value of 0.825 is consistent with the interval's lack of a clear separation from the no-difference point, but it adds no measure of effect size. Precision is also conditional on the analysis choices, including the full analysis set and last-observation-carried-forward imputation. The registry record does not report sensitivity analyses or the interval's confidence level, so those aspects of uncertainty cannot be evaluated from the posted result.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, because the displayed calculation concerns a continuous outcome rather than a time-to-event endpoint. For time-to-event calculations, the stated convention is total number of events; that convention does not apply to these HbA1c planning illustrations. The columns describe planning for 80% power and 90% power: in general, those percentages represent the probability of detecting the specified effect if it is truly present, under the calculation assumptions.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. The table gives participants per arm for 80% power and participants per arm for 90% power at each fraction. For 100% of the observed effect, the entries are 35,796 and 47,921; for 75% of the observed effect, they are 63,637 and 85,192; and for 50% of the observed effect, they are 143,183 and 191,681.

These figures are planning illustrations derived from the observed effect, not the trial's own original design calculation. The registry record does not report the original sample-size assumptions or justification. Because smaller effects are harder to distinguish from random variation, planning to detect a smaller fraction of the observed effect requires more participants under the stated assumptions. The curve should be read as another depiction of this relationship, not as a separate result about participants enrolled in the trial. These figures are not observed power.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.020; pooled standard deviation σ = 0.955.
2. n = 2 × (1.96 + 0.842)² × 0.955² / -0.020² = 35,795.6, rounded up to 35,796 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.02                      # observed difference in means
sigma <- 0.955050232158469                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1009580)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 35,796 (80% power), 47,921 (90% power)
 75% of observed effect: n per arm = 63,637 (80% power), 85,192 (90% power)
 50% of observed effect: n per arm = 143,183 (80% power), 191,681 (90% power)
power.t.test: 35796.6 
Simulated power at n = 35,796 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record identifies a primary HbA1c endpoint and lists secondary outcomes, but it does not report a multiplicity strategy. It is therefore unclear whether the trial used an adjustment for testing several outcomes, a hierarchy that controlled which comparisons were confirmatory, or another prespecified approach. The posted p-value for the primary comparison is described as unadjusted, and the secondary glucose-profile p-value is also unadjusted. Without a stated plan, the reader should not assume these values control the chance of false-positive findings across the full set of outcomes.

The record lists three secondary outcomes, but numerical results are posted for only the mean 9-point Self Measured Plasma Glucose Profile. Results for the rates of confirmed and nocturnal confirmed hypoglycaemic episodes are not reported in the registry record. The registry also does not report analyses that would show whether these missing outcome results were unavailable, omitted, or not analyzed. No explanation for their absence is given.

For the primary endpoint, the full analysis set is described as including all randomized subjects, with missing data imputed using last observation carried forward. One subject randomized in error was removed from this set. This is important context for interpreting the primary means and comparison: the stated analysis is not simply a summary of observed Week 26 measurements for every randomized subject, because missing values may have been replaced using earlier observations.

The record does not report the amount or pattern of missing primary endpoint data, alternative imputation approaches, or sensitivity analyses. It also does not report the original analysis plan, interim analyses, or a detailed account of analysis-population decisions beyond the stated exclusion. These omissions restrict assessment of how robust the primary conclusion is to different reasonable analysis choices. They do not invalidate the posted estimates, but they limit what can be established from the registry results alone.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hypoglycaemia (2.7%), hypoglycaemic unconsciousness (2.3%), diabetic retinopathy (0.9%), gastroenteritis (0.9%), angina pectoris (0.5%).

The registry lists serious adverse events for 19 of 224 participants in the IDegAsp group and 36 of 222 participants in the BIAsp 30 group. It lists other adverse events for 60 of 224 and 52 of 222, respectively. These are counts with their recorded group denominators; they are not measures of the HbA1c outcome and should be read separately from the efficacy endpoint.

The listed serious-event terms include hypoglycaemia at 2.7%, hypoglycaemic unconsciousness at 2.3%, diabetic retinopathy at 0.9%, gastroenteritis at 0.9%, angina pectoris at 0.5%, and angina unstable at 0.5%. The registry does not specify a group attribution for these listed percentages in the posted terms, so they should not be assigned to either arm. Death results are not reported in the registry record.

Adverse-event summaries are descriptive and do not, by themselves, establish that a treatment caused an event or that one group has a reliably different risk. The record does not provide event-level timing, exposure-adjusted rates, or a statistical comparison for these summaries. The open-label design and the 26-week follow-up also frame what these safety entries can describe.

16. What the Result Does, and Does Not, Mean

The primary posted result describes the average change in HbA1c over 26 weeks in the analyzed groups. Both group means were below baseline, and the estimated between-group mean difference was -0.02. The interval includes values on both sides of the no-difference point, while the unadjusted p-value is 0.825. Taken together, these statistics do not show a clear separation in mean change in the reported analysis.

That interpretation is narrower than saying the treatments are equivalent. An estimate near the no-difference point does not prove equality, and an interval that spans both directions leaves uncertainty about the true contrast. The registry record does not report a prespecified equivalence or non-inferiority margin, so the posted primary comparison cannot be treated as a formal test of equivalence or non-inferiority.

The result also does not establish that every participant experienced a change like the group mean. Means summarize the center of the observed distributions; they do not show individual response patterns or the proportion meeting a clinical threshold. No such primary responder result is reported in the registry record. The primary endpoint is a laboratory measure and does not, on its own, represent every clinical outcome relevant to participants.

Randomization supports a comparison of assigned groups, but the trial was open-label and the registry record does not report full details of allocation procedures, the original statistical plan, or sensitivity analyses for missing data. The primary analysis used last observation carried forward and excluded one participant randomized in error. Those analysis choices and reporting gaps should accompany any interpretation of the estimate.

The finding is limited to the stated population, endpoint, and 26-week period. It does not establish longer-term outcomes or resolve the secondary hypoglycaemia results, which are not reported in the registry record. The adverse-event counts are descriptive and do not independently determine comparative safety. The posted data are therefore best understood as a specific, uncertain estimate of mean HbA1c change rather than a complete account of comparative clinical effects.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison is interpreted through the difference between group outcomes, not by looking only at whether each group changed from baseline. The mean HbA1c changes were -1.28 and -1.3, whereas the between-group estimate was -0.02. The two within-group changes describe the groups; the contrast addresses the comparative question.

It also shows the importance of reading an estimate alongside its uncertainty. The primary interval extends across the no-difference point, and the unadjusted p-value is 0.825. Neither a small point estimate nor a large p-value proves that there is no difference. The interval helps communicate the range of contrasts compatible with the analysis, while leaving uncertainty about the precise size and direction.

The planning illustrations make another statistical issue visible: sample-size requirements depend on the effect a study aims to detect. The figures based on smaller fractions of the observed effect require more participants under the stated assumptions. They are not the trial's original design justification, which is not reported in the registry record, and they are not observed power.

Finally, the record demonstrates how missing-data methods, outcome multiplicity, and incomplete reporting affect interpretation. The primary endpoint used last observation carried forward, the original analysis plan and multiplicity strategy are not reported, and numerical results for two listed secondary outcomes are absent. A careful statistical reading therefore combines the estimate and interval with the limits of the record rather than relying on a single p-value.

18. 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 open-label design is a trial-specific limitation. Masking was listed as none, and the registry record does not describe whether outcome assessors or analysts were masked separately. Even with a laboratory endpoint, awareness of assignment could influence participant behavior, care, or other trial processes. The available record does not quantify such effects.

The primary analysis used last observation carried forward for missing data. The registry record does not report the extent or pattern of missingness, alternative imputation analyses, or sensitivity analyses. Since the imputation method assumes an earlier value can stand in for a later missing measurement, the robustness of the primary estimate to other assumptions cannot be assessed from the posted results.

The record does not report the primary statistical model, covariate adjustment, original sample-size justification, allocation concealment details, interim analyses, or a prespecified multiplicity plan. Those omissions make it difficult to verify the relationship between the posted estimates and the complete protocol-level analysis plan. The confidence level for the reported interval is also not stated in the registry record.

Reporting of secondary results is incomplete: numerical outcomes are not reported in the registry record for confirmed hypoglycaemic episodes or nocturnal confirmed hypoglycaemic episodes. The serious-event term percentages are listed without arm attribution in the posted summary, and death results are not reported in the registry record. The safety summaries therefore do not supply a complete comparative account.

Lastly, follow-up was 26 weeks, and the primary outcome was mean HbA1c change. These results do not describe longer-term outcomes, individual response distributions, or all possible clinical effects. The trial's regional scope is recorded as Asia, Europe, and Oceania; the registry does not provide enough information to determine how well the results apply to populations outside the stated eligibility and trial setting.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes — NCT01009580.
• Registry record last updated 2018-12-19; status last verified 2018-11.
• Results first posted 2015-11-20.
• 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.

22. Record Summary

NCT01009580 is a completed phase 3 randomized, open-label, parallel-group trial comparing IDegAsp twice daily with BIAsp 30 twice daily in people with type 2 diabetes. The registry records enrollment of 447 and a 26-week primary endpoint period. The primary outcome was change in HbA1c from baseline to Week 26, analyzed in a full analysis set with last observation carried forward for missing data; one participant randomized in error was excluded from that set.

The posted mean changes were -1.28 and -1.3, with an estimated mean difference of -0.02, an interval from -0.197 to 0.157, and an unadjusted p-value of 0.825. The interval includes values on both sides of the no-difference point. The registry does not report the original sample-size justification, a multiplicity strategy, or a full analysis plan. Numeric results for two listed hypoglycaemia secondary outcomes are not reported in the registry record.