Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (NCT03434119), a randomized phase 3 study. The primary outcome is Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26.

2. Clinical Question

HbA1c is a measure of glycated hemoglobin and is used to assess average blood glucose over time. The primary endpoint is a change score: the Week 26 value minus the baseline value. A negative change therefore denotes a lower Week 26 HbA1c than at baseline. This trial's central statistical question is about the difference between the groups' average changes, rather than whether either group's average changed in isolation.

3. Trial Design

This was a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter study. The registry record lists enrollment of 241 and a planned treatment period of 26 weeks. The study began on 2018-02-20, had primary completion on 2019-01-07, and is listed as terminated. The reason for termination is not reported in the registry record.

Participants were assigned to Soliqua 100/33 or Lantus. Both groups continued oral antidiabetic drug therapy. The regimens differed in the study medication and in the instructions for timing the daily dose: Soliqua was taken in the morning within 1 hour before breakfast, whereas Lantus could be taken at any time provided dosing was at about the same time each day. Masking was not used, so participants and study personnel were not blinded to the assigned treatment.

The primary measure was change from baseline in HbA1c at Week 26. The registry record describes the primary analysis population as the intent-to-treat population, which included all randomized participants; for this outcome, the number analyzed was the number with available data. The posted endpoint summaries list 19 participants for Soliqua and 26 for Lantus. The registry record does not explain why the endpoint analysis counts differ from the overall enrollment, nor does it provide a detailed account of missing endpoint data.

The objectives also included subgroup-specific efficacy and safety assessments, change in daily insulin glargine dose, and tolerability. The record lists additional outcomes covering HbA1c target attainment, meal-test glucose measures, insulin dose, body weight, and hypoglycemic events. Details of the randomization procedure, allocation concealment, subgroup sizes, original sample-size justification, and interim monitoring are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Randomization was stratified by self-reported ethnic/racial group, screening HbA1c values (\<8.5% vs \>=8.5%), background use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors (yes/no), background use of sulfonylureas (yes/no). Assignment to arms was done centrally by an interactive response technology (IRT) in 1:1 ratio (Soliqua 100/33:Lantus).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Analysis was performed on intent-to-treat (ITT) population that included all randomized participants. Here, overall number of participants analyzed = participants with available data for the specified outcome measure.

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: Analysis was performed on randomized population.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26, measured over Baseline, Week 26.

The primary endpoint is the change in glycated hemoglobin (HbA1c) from baseline to Week 26, expressed as a percentage of HbA1c. The registry defines change as the Week 26 value minus the baseline value. This makes the endpoint a continuous measure: each participant can have a value across a range, and the result can be summarized by a group mean and standard deviation.

HbA1c is commonly used in diabetes trials because it reflects average blood glucose over time rather than a single measurement at one moment. A change score connects the follow-up measure to the participant's own baseline, while comparing average changes between randomized groups addresses the treatment contrast of interest. A negative mean change indicates that the follow-up value was lower on average than baseline; it does not describe every participant's individual course.

In this study the endpoint was assessed at Week 26, after the planned treatment period. The posted means were -1.86 for Soliqua and -1.07 for Lantus. These are group averages among participants with available endpoint data, not estimates for every person enrolled. The registry record does not report the laboratory procedures, additional endpoint measurement details, or a model-based adjusted estimate for this outcome.

7. Results Posted in the Registry

• Lantus: mean -1.07 versus -1.86 on control; difference 0.79 (95% CI 0.17 to 1.41), standardized effect d = 0.73; z-test p = 0.013.

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.

Percentage of Participants Achieving HbA1c Target of <7% at Week 26

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Lantus: 30.8% (8/26) versus 52.6% (10/19) on control; risk difference -21.9 percentage points (95% CI -50.5 to 6.8), risk ratio 0.58 (0.29–1.20); unadjusted two-proportion z-test p = 0.139.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lantus and the control. The interval gives the range of effects that remain compatible with the data.

Change From Baseline in Body Weight at Week 26

• 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:
  • Lantus: mean 1.52 versus 1.69 on control; difference -0.17 (95% CI -2.26 to 1.92), standardized effect d = -0.05; z-test p = 0.873.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lantus and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results span a binary HbA1c target outcome and a continuous body-weight outcome. Their statistical pattern is less conclusive than the primary comparison: the target-attainment interval includes no difference, and the body-weight estimate is small relative to an interval that includes values in either direction. The registry record also lists other secondary outcome topics, including meal-test glucose, daily insulin glargine dose, and hypoglycemic events; results for those outcomes are not reported in the registry record.

These outcomes address related but distinct questions. Target attainment asks about the proportion reaching a threshold, whereas continuous HbA1c change uses the full range of measured values. Meal-test glucose and insulin dose concern other aspects of glucose management and treatment use, while body weight and hypoglycemic events address different outcomes. They can add context to the primary endpoint but do not replicate it or provide an automatic confirmation of its result.

Unadjusted secondary findings carry less weight because multiple outcomes create multiple opportunities to observe a low p-value by chance. The registry record does not report a multiplicity-control approach, a prespecified testing hierarchy, or secondary model adjustments. It also does not report secondary analyses within the ethnic and racial subgroups described in the objectives. The listed secondary p-values should therefore be read as unadjusted evidence for their specific comparisons, not as a collection of confirmatory conclusions.

Across the available results, the primary endpoint provides the clearest posted between-group signal, while the available secondary comparisons remain uncertain. That pattern does not show that secondary outcomes agree or disagree biologically with the primary outcome; rather, it reflects that they measure different things and have their own estimates and precision. The absence of posted results for some listed outcomes leaves the overall secondary profile incomplete.

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

• Percentage of Participants Achieving HbA1c Target of <7% at Week 26
• Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26
• Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26
• Change From Baseline in Daily Insulin Glargine Dose at Week 26
• Change From Baseline in Body Weight at Week 26
• Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period

9. Statistical Interpretation

10. Statistical Methods Explained

The registry record presents group means and standard deviations for the continuous primary outcome, together with an unadjusted mean difference, confidence interval, and p-value. The primary outcome is a change score, calculated by subtracting the baseline HbA1c value from the Week 26 value. The comparison is between the average change in the Soliqua group and the average change in the Lantus group.

What does the mean difference represent?

A mean is the arithmetic average of the observed values in a group. For the primary endpoint, the posted means are -1.86 for Soliqua and -1.07 for Lantus. The comparison is reported as Lantus minus Soliqua, giving a mean difference of 0.79. Because both means are negative, the positive contrast reflects that the Lantus group's mean change was less negative than the Soliqua group's mean change. This is a contrast of group averages; it does not imply that all participants had changes in the same direction or of similar size.

The standard deviation describes variation among observed participant values around a group mean. The posted standard deviations are 0.96 for Soliqua and 1.17 for Lantus. A standard deviation is not the same as a standard error: the standard deviation concerns the spread of participant outcomes, whereas the standard error concerns the uncertainty in an estimated statistic such as a mean or difference.

How should the p-value be understood?

The primary comparison has an unadjusted p-value of 0.013. In general, a p-value describes how incompatible the observed result, or a more extreme result, would be with a specified null model in which the true contrast is zero. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The record labels this result unadjusted; it does not report a multiplicity adjustment for the primary comparison or describe a testing hierarchy.

The unadjusted p-value should be read alongside the estimated difference and confidence interval. The estimate describes the direction and scale of the contrast, while the interval communicates uncertainty about its value. Neither statistic answers questions about unreported subgroup effects or the robustness of results to missing outcomes.

Why does the analysis population matter?

The registry describes the primary population as intent-to-treat, including all randomized participants. It also says that the number analyzed for the endpoint is the number with available data. The posted primary group summaries have 19 participants for Soliqua and 26 for Lantus. This means the displayed endpoint statistics are based on participants with an observed value for that measure, not necessarily every randomized participant. The registry record does not report the reasons for unavailable data or a sensitivity analysis addressing missing outcomes.

In general, intent-to-treat analysis aims to preserve the comparison created by random assignment by analyzing participants according to their assigned group. When endpoint values are unavailable, the handling of those missing values matters. The registry description does not specify an imputation method, a model for incomplete follow-up, or an analysis that estimates outcomes for participants without an observed Week 26 value. Such details are not reported in the registry record and should not be inferred from the label alone.

What is the role of randomization and masking?

Randomization assigns participants to groups by chance and, in general, helps balance measured and unmeasured characteristics across groups on average. The record states that allocation was randomized, but the sequence-generation and concealment procedures are not reported. Masking was not used. In general, awareness of assigned treatment can affect participant behavior, co-interventions, reporting, or study conduct. The primary endpoint is a laboratory-based measure, but details of measurement and safeguards are not reported in the registry record.

The trial is described as parallel-group and active-controlled. Each group received its assigned regimen over the study period, and the comparison is between the groups rather than a within-person crossover. The active comparator was Lantus, with oral antidiabetic therapy continued in both arms. The record does not report treatment adherence or detailed co-intervention information.

What can be inferred from the secondary measures?

The registry lists secondary measures of target attainment, postprandial glucose and meal-test glucose excursion, daily insulin glargine dose, body weight, and hypoglycemic events. The posted results include a target-attainment comparison and a body-weight comparison. For binary outcomes such as target attainment, the group summaries are percentages and the contrast is a risk difference; a risk difference expresses the absolute difference between group proportions. The posted analysis also includes relative risk and odds ratio summaries, which express relative comparisons on different scales.

For continuous outcomes such as body weight, a mean difference compares average changes between groups. The posted weight means are 1.69 kg for Soliqua and 1.52 kg for Lantus, with a mean difference of -0.17 kg. In general, continuous and binary outcomes answer different questions and their effect measures are not interchangeable. The registry record does not report adjusted secondary models, subgroup analyses, or a multiplicity procedure. Secondary estimates and p-values should therefore be treated as exploratory or descriptive rather than as a set of independent confirmatory tests.

In general, over-dispersion matters when count or binary data vary more than an assumed statistical model allows: an underestimated variance can make intervals too narrow and tests too optimistic. The posted primary outcome is continuous, and the registry record does not describe a count model or an over-dispersion adjustment. No such model should be assumed from the summary statistics.

11. Confidence Intervals and Precision

The primary mean difference is 0.79, with an unadjusted confidence interval whose lower and upper bounds are both positive. The posted lower bound is 0.167 and the upper bound is 1.413; the lower bound is displayed as a positive value rather than with additional precision. The interval's exclusion of zero is consistent with the unadjusted p-value of 0.013. The estimate is more informative when read with the interval than when read alone, because the interval shows a range of values compatible with the posted data and calculation.

In general, a confidence interval represents the uncertainty of an estimate under the assumptions of its statistical method. It is not a range containing the individual participant outcomes, nor is it a guarantee that the true effect falls within the particular interval. The width reflects both observed variability and the amount of information available. In this trial, the endpoint summaries are based on 19 Soliqua participants and 26 Lantus participants, and the registry record does not report a model-based adjustment or a missing-data sensitivity analysis that could further inform precision.

The secondary comparisons have less precise estimates. For HbA1c target attainment, the posted risk-difference interval includes zero. For body-weight change, the posted mean-difference interval extends from -2.256 to 1.916 kg, spanning values on both sides of zero. These intervals communicate uncertainty, not proof of equivalence or proof that an effect is absent. The number of outcomes considered and the lack of a reported multiplicity plan also matter when interpreting secondary p-values.

Precision is distinct from clinical importance. A narrow interval can still surround an effect whose practical importance requires context, while a wide interval can leave substantial uncertainty about both direction and magnitude. The registry record does not provide a clinically important threshold for HbA1c change, target attainment, or weight, so the statistical summaries alone cannot establish whether a difference is clinically meaningful.

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 sample-size planning figures are illustrations based on observed effects, not the original trial design. For these non-time-to-event outcomes, the displayed estimates are participants per arm, rather than total events. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The calculations consider detecting a stated fraction of the observed effect. The original design assumptions and the trial's own sample-size justification are not reported in the registry record.

The 80% power column describes the planned number of participants per arm under which the calculation would have an 80% chance of detecting the specified effect if that effect were the true one and the planning assumptions held. The 90% column uses a higher target probability of detection, so its participant requirement is larger. These are prospective planning concepts, not evidence about what happened in this completed trial.

Each planning row scales the observed effect to a different size. Planning for a smaller effect requires more participants per arm, because a smaller difference is harder to distinguish from random variation. The displayed estimates are consequently sensitive to the observed effect used as their starting point. In particular, a small observed contrast can generate very large planning estimates when the calculation asks for a fraction of that already small contrast.

These figures are not observed power. They do not describe the probability that this trial detected its true effect after the results were known, and they do not alter the uncertainty in the posted confidence intervals. They are planning illustrations based on the stated assumptions, not a retrospective measure of trial success or a substitute for the trial's unreported original design rationale.

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 = 0.790; pooled standard deviation σ = 1.087.
2. n = 2 × (1.96 + 0.842)² × 1.087² / 0.790² = 29.7, rounded up to 30 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 <- 0.79                      # observed difference in means
sigma <- 1.08704100177265                     # 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(3434119)
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 = 30 (80% power), 40 (90% power)
 75% of observed effect: n per arm = 53 (80% power), 71 (90% power)
 50% of observed effect: n per arm = 119 (80% power), 160 (90% power)
power.t.test: 30.7 
Simulated power at n = 30 per arm: 0.792 (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 study had a primary HbA1c endpoint and several secondary outcomes, and its objectives included evaluations within ethnic and racial subgroups. Whenever multiple outcomes, subgroups, time points, or comparisons are tested, the chance of at least one apparently notable result can increase. Multiplicity procedures are used in some trial designs to control that risk, for example by adjusting significance thresholds or prescribing an order for testing.

The registry record does not report a multiplicity adjustment, a prespecified testing sequence, or a strategy for interpreting the primary and secondary comparisons together. The posted p-values are identified as unadjusted. Accordingly, the primary p-value should be understood as an unadjusted result, and the secondary p-values should not be treated as if they were protected from the consequences of multiple testing. The record also does not state whether subgroup tests were intended to be confirmatory or exploratory.

The record describes the primary analysis population as intent-to-treat, including all randomized participants, but notes that the endpoint analysis count depends on available data. The posted primary summaries include 19 participants in the Soliqua group and 26 in the Lantus group. The record does not report why endpoint data were unavailable for other enrolled participants, how missing values were handled, or whether results were tested under alternative assumptions about missingness.

These omissions matter because incomplete outcome data can affect both the estimated contrast and its precision, especially if availability is related to treatment assignment or participant outcomes. That possibility cannot be evaluated from the posted summary alone. The registry record also does not report an analysis plan detailing covariate adjustment, subgroup modeling, interim analyses, or sensitivity analyses. These elements should be treated as not reported in the registry record, rather than inferred from the trial's phase, design labels, or stated objectives.

15. Safety Results

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

Deaths

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: acute myocardial infarction (0.9%), atrial fibrillation (0.9%), cardiac failure congestive (0.9%), coronary artery disease (0.9%), myocardial infarction (0.9%).

The registry lists serious adverse events for 115 participants at risk in the Soliqua group, with 7 affected, and 125 participants at risk in the Lantus group, with 4 affected. It lists other adverse events for 115 at risk in the Soliqua group, with 21 affected, and 125 at risk in the Lantus group, with 20 affected. Deaths are listed as 0 in each group. These are safety summaries, separate from the smaller endpoint-analysis counts reported for the primary efficacy outcome.

The listed serious-event terms each have a reported value of 0.9%: Acute Myocardial Infarction, Atrial Fibrillation, Cardiac Failure Congestive, Coronary Artery Disease, Myocardial Infarction, and Hypoglycaemia. These entries describe terms recorded in the registry and do not by themselves establish that treatment caused an event. The registry record does not provide a causal assessment or additional detail on event timing, duration, severity beyond the serious classification, or participant-level overlap among terms.

Safety counts are interpreted in light of the number at risk and the event definitions used. They are not a direct comparison of treatment benefit, and the registry record does not report a formal statistical comparison of these safety figures. The listed counts should be read descriptively, without combining categories or assuming that each event term represents a separate participant.

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

The primary result describes an average change in HbA1c among participants with available endpoint data. The Soliqua mean was -1.86 and the Lantus mean was -1.07, with a posted mean difference of 0.79 for Lantus minus Soliqua. The interval for the primary contrast lies on the positive side of zero, and the unadjusted p-value is 0.013. Together, these statistics indicate that the posted group averages differed in this analysis.

That statistical result is not a complete account of clinical importance. The registry record does not give a threshold for a clinically meaningful HbA1c difference, nor does it report a detailed analysis of individual response patterns. A group mean can conceal variation among participants: some may have had larger changes, smaller changes, or changes in the opposite direction. The posted summaries do not establish what happened for each participant.

The result also should not be generalized automatically to the planned ethnic and racial subgroups. Although subgroup assessments were stated as objectives, subgroup-specific outcome results are not reported in the registry record. The trial was open-label, was listed as terminated, and the reason for termination is not reported. The record does not explain the difference between total enrollment and the smaller numbers contributing to the primary endpoint summaries, or provide a sensitivity analysis for missing data.

Secondary outcomes provide additional but limited context. The posted target-attainment interval includes no difference, and the weight comparison is imprecise. Other listed secondary topics do not have results reported in the registry record. The absence of a multiplicity plan means secondary p-values should not be treated as independent confirmatory evidence. Safety summaries list adverse events and no deaths in either group, but they do not by themselves establish causality or comparative safety.

Thus, the posted result supports a descriptive statistical statement about the available primary endpoint data. It does not, on its own, establish a universal treatment effect, settle the subgroup questions, explain missing outcomes, or show how the result compares with a prespecified clinically important threshold. No medical recommendation follows from these registry summaries alone.

17. Why This Trial Matters Statistically

This trial raises several useful statistical issues for readers of clinical research. First, the primary result is a comparison of mean changes, not simply a comparison of follow-up values. Interpreting the sign of the contrast requires knowing which group is subtracted from which. Here the reported comparison is Lantus minus Soliqua, while both group means are negative. Keeping the contrast direction explicit prevents a positive difference from being mistaken for an increase in HbA1c in both groups.

Second, the record distinguishes overall enrollment from the number of participants with available primary endpoint data. The primary analysis is described as intent-to-treat, but the outcome summaries rely on available data. This illustrates why an analysis-population label should be read together with the endpoint-specific denominators and the missing-data description. The registry record does not explain the missing endpoint values, so the influence of missingness cannot be assessed from the posted summaries.

Third, the study's stated interest in ethnic and racial diversity makes subgroup questions salient, but objectives are not the same as reported subgroup evidence. The registry record does not report those subgroup results. Without subgroup estimates and their uncertainty, the overall comparison cannot answer whether the observed pattern was similar across the specified groups.

Finally, the primary result and the secondary outcomes have different roles. The primary endpoint has an unadjusted confidence interval that excludes zero, while the available secondary comparisons are less conclusive and the record gives no multiplicity strategy. Reading the outcomes as a coherent statistical plan requires information not reported in the registry record, including the original analysis plan and the rationale for the planned sample size.

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.

Several trial-specific limitations constrain interpretation. The registry lists the study as terminated, but the reason for termination is not reported. It also records enrollment of 241 while the primary endpoint summaries include 19 participants in the Soliqua group and 26 in the Lantus group. The record says the number analyzed was based on available outcome data, but does not explain the difference or report how missing endpoint values were handled.

The study was open-label, with no masking. This does not by itself determine the direction or size of any bias, but knowledge of assigned treatment can influence behavior, reporting, and study conduct in general. The registry does not report details that would allow evaluation of these potential influences, including adherence information or a complete account of measurement procedures.

The population was intended to support ethnic and racial subgroup assessments, but subgroup-specific results are not reported in the registry record. Therefore, the primary overall comparison cannot be used to describe outcomes in each subgroup. The record also does not report participant characteristics in enough detail to assess the composition or representativeness of the analyzed population.

Only selected secondary results are available in the posted outcome summaries. The registry record does not report results for all secondary topics listed, a multiplicity strategy, detailed model specifications, sensitivity analyses, interim analyses, or the original sample-size justification. The sample-size calculations associated with the observed effects are planning illustrations, not evidence about the original design. These limitations leave uncertainty about robustness, generalizability, and the completeness of the outcome picture.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents — NCT03434119.
• Registry record last updated 2022-03-28; status last verified 2022-03.
• Results first posted 2020-01-13.
• 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

The registry record describes NCT03434119, a Phase 3 randomized, open-label, active-controlled, parallel-group, multicenter study of Soliqua 100/33 versus Lantus in people with type 2 diabetes inadequately controlled on basal insulin and oral antidiabetic agents. Enrollment was 241, and the planned treatment period was 26 weeks. The record lists the study as terminated; the reason is not reported.

The primary endpoint was change from baseline in HbA1c at Week 26. The posted means were -1.86 for Soliqua and -1.07 for Lantus, with a mean difference of 0.79 and an unadjusted p-value of 0.013. The endpoint summaries included 19 and 26 participants, respectively. The registry record does not report subgroup-specific primary results, the original sample-size justification, detailed missing-data handling, or a multiplicity strategy.

Selected secondary outcomes and descriptive safety counts are also recorded. These summaries provide additional context but do not replace the primary comparison or resolve the limitations associated with incomplete outcome reporting and uncertainty about missing data.