Liraglutide in the Treatment of Type 1 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Liraglutide in the Treatment of Type 1 Diabetes Mellitus (NCT01722266), a randomized phase 3 study. The primary outcome is Change in Mean Weekly Glucose Concentrations.

2. Clinical Question

The registry's stated primary endpoint description frames the aim as detecting a difference from baseline in mean weekly blood glucose in each liraglutide group after 12 weeks. The posted outcome results also permit unadjusted comparisons of mean changes between each dose group and placebo. Those comparisons are recalculations from the posted group summaries, not a reported sponsor analysis; the registry record lists no reported analyses.

The broader study questions included glucose patterns from continuous glucose monitoring, meal-related glucose, HbA1c, glucagon, C-peptide, and gastric emptying. The study description names these aims, but not every planned measure has a result in the registry record. The results available therefore address only part of the stated research program. The trial record does not establish what happened in unreported outcomes or explain the analytic choices used by the investigators.

3. Trial Design

This was a randomized, triple-masked, parallel-group phase 3 study sponsored by the University at Buffalo. The registry record lists the study as completed and gives enrollment of 72. The treatment arms were placebo and daily liraglutide injections at 0.6 mg, 1.2mg, or 1.8mg. Arm-specific counts attached to the primary results were 17 for placebo, 18 for liraglutide 0.6 mg, 13 for liraglutide 1.2mg, and 15 for liraglutide 1.8mg. The registry does not explain why these result counts differ across arms or how they relate to all enrolled participants.

The primary endpoint was assessed at 12 weeks. The study description includes baseline and follow-up measurements and identifies additional planned glucose, metabolic, and gastric-emptying outcomes. A full protocol, detailed visit schedule, allocation ratio, eligibility criteria, and original sample-size rationale are not reported in the registry record. The duration of the trial as a whole should not be inferred from the primary endpoint timeframe.

Masking is recorded as triple, but the registry record does not specify which groups of people were masked or describe procedures for maintaining masking. It also does not give details about randomization sequence generation or concealment. These labels describe the broad design as recorded, not all practical safeguards or analytic methods. The record reports 72 participants enrolled; the arm-level result counts refer to the samples contributing to particular posted outcome summaries and should not be treated as a complete account of participant flow.

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

Reasons for not completing this period:

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 Mean Weekly Glucose Concentrations, measured over 12 Weeks.

The primary endpoint was change from baseline in mean weekly blood glucose concentrations after 12 weeks, measured in mg/dl. The registry describes the goal as assessing whether this measure differed from baseline within each liraglutide group. The posted summaries give a mean change for placebo and for each dose group, with standard errors. Comparisons with placebo can help quantify how the average change differed between groups, although the registry does not report a sponsor analysis of those comparisons.

Mean weekly glucose condenses repeated glucose measurements into an average for a week. As a general statistical concept, an average is useful for describing the overall level of a continuous measure, but it can conceal variation over time or among participants. The study description separately mentions glucose variability and time spent above or below specified glucose concentrations; those are distinct measures and are not interchangeable with the mean. Their results are not reported in the registry record.

The endpoint is relevant to the study's stated question about glucose concentrations, but it does not by itself describe other aspects of diabetes management or establish a mechanism. It also does not show whether any group differences persisted beyond the stated 12-week timeframe. Interpretation depends on the magnitude and precision of the posted changes, how the groups were analyzed, and the completeness of outcome reporting.

7. Results Posted in the Registry

• Liraglutide 1.8mg: mean -10.00 versus 1.00 on control; difference -11.00 (95% CI -12.96 to -9.04), standardized effect d = -4.16; z-test p = <0.001.
• Liraglutide 1.2mg: mean -10.00 versus 1.00 on control; difference -11.00 (95% CI -14.92 to -7.08), standardized effect d = -2.33; z-test p = <0.001.
• Liraglutide 0.6 mg: mean -0.30 versus 1.00 on control; difference -1.30 (95% CI -5.22 to 2.62), standardized effect d = -0.21; z-test p = 0.516.

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.

Change in HbA1c

• 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 errors.
• Result:
  • Liraglutide 1.8mg: mean -0.42 versus -0.30 on control; difference -0.12 (95% CI -0.54 to 0.30), standardized effect d = -0.20; z-test p = 0.572.
  • Liraglutide 1.2mg: mean -0.78 versus -0.30 on control; difference -0.48 (95% CI -0.90 to -0.06), standardized effect d = -0.82; z-test p = 0.024.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liraglutide 1.8mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Liraglutide 1.2mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Body Weight From Baseline

• 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 errors.
• Result:
  • Liraglutide 1.8mg: mean -4.80 versus -0.30 on control; difference -4.50 (95% CI -6.19 to -2.81), standardized effect d = -1.89; z-test p = <0.001.
  • Liraglutide 1.2mg: mean -5.00 versus -0.30 on control; difference -4.70 (95% CI -7.25 to -2.15), standardized effect d = -1.45; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Liraglutide 1.8mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Liraglutide 1.2mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Total Insulin Dose From Baseline

• 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 errors.
• Result:
  • Liraglutide 1.8mg: mean -10.00 versus -3.40 on control; difference -6.60 (95% CI -8.29 to -4.91), standardized effect d = -2.65; z-test p = <0.001.
  • Liraglutide 1.2mg: mean -12.10 versus -3.40 on control; difference -8.70 (95% CI -10.64 to -6.76), standardized effect d = -3.18; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Liraglutide 1.8mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Liraglutide 1.2mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcomes cover HbA1c, body weight, total insulin dose, and other listed measures. The result pattern across the reported continuous outcomes is not uniform: some comparisons show clearer separation from placebo in their unadjusted recalculations, while others are less precise or include little evidence of a clear group difference in the posted summaries. The accompanying outcome results are useful for context, but they do not replace or validate the primary endpoint.

Some secondary measures relate to glucose management or other metabolic changes, while others describe body weight or insulin dose. They may help characterize the scope of the recorded results, but their relationship to the primary glucose measure is not established by the posted data alone. In particular, an apparent pattern across multiple endpoints does not demonstrate a mechanism, prove consistency for individual participants, or establish that changes in one measure caused changes in another.

The registry record lists several secondary outcomes but no reported analyses for them. The recalculated comparisons are unadjusted, and the record does not describe a multiplicity procedure. As a general statistical matter, testing many outcomes increases the chance that some comparisons appear noteworthy by chance, even when no underlying group difference exists. This makes isolated unadjusted secondary results less persuasive than a prespecified primary analysis with a reported analytic plan.

Interpret secondary outcomes as exploratory evidence about the observed study summaries, not as independent confirmations of the primary finding. The registry record does not report all planned outcomes or explain why particular secondary results are posted. Missing detail about participant flow, analysis populations, and handling of missing data also applies to these outcomes. A coherent assessment would require the protocol, statistical analysis plan, and sponsor-reported analyses, none of which are described in sufficient detail in the registry record.

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

• Change in HbA1c
• Change in Body Weight From Baseline
• Change in Total Insulin Dose From Baseline
• Change in the Area Under Curve (AUC) of Glucose Following the Meal
• Change in Carbohydrate Intake
• Change in Glucagon Concentrations

9. Statistical Interpretation

10. Statistical Methods Explained

For a continuous outcome such as mean weekly glucose, the reported mean change describes the average change in a group. A mean difference between groups describes how far apart their average changes are, with the sign indicating direction according to the subtraction order used in the recalculation. Here, a negative difference means the posted average change in the liraglutide group was lower than the posted average change in placebo. This does not mean every participant had a decrease or that the group averages describe individual trajectories.

What does the standard error describe?

The standard error (SE) describes the estimated precision of a group mean, rather than the spread of individual participant values. As a general statistical explanation, a smaller SE indicates a more precisely estimated mean under the assumptions of the analysis. It is not the same quantity as a standard deviation. The primary results give a standard error for each mean; the placebo SE is recorded as 0.0. The registry does not explain how that value arose, and it should not be interpreted as proof that all placebo participants had identical measurements.

What does a confidence interval add?

A confidence interval expresses uncertainty around an estimated difference. As a general concept, it gives a range of values compatible with the estimate under the method's assumptions; it is not a range containing a specified fraction of individual participant outcomes. A relatively narrow interval indicates more precision than a wide interval, while an interval spanning zero includes both directions of difference under that calculation. The intervals accompanying the primary comparisons are recalculated from posted summaries and are not identified as sponsor-reported intervals.

How should the p-values be read?

A p-value describes how unusual data at least as discrepant as the observed data would be under a specified null model and its assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a difference. The primary p-values shown for group comparisons are unadjusted recalculations. The registry record does not report the sponsor's analysis or specify its statistical model, so these p-values cannot be assumed to reproduce the trial's planned inference.

For general interpretation, inference is affected by sample size, outcome variability, model choice, and the way repeated measurements and baseline values are handled. Repeated glucose readings within a participant are related rather than independent observations; analyses of such data need to account appropriately for that structure. The study description mentions continuous glucose monitoring but does not report the analytic model used for those data. The posted primary endpoint is a summary mean, and the exact calculation behind each reported change is not fully described.

The pairwise differences presented against placebo are not evidence of a dose-response relationship. Such a conclusion would require a prespecified comparison or trend analysis and a suitable model; neither is reported in the registry record. Likewise, a small p-value for a recalculated group contrast does not settle whether the result is robust to missing data, baseline adjustment, or multiplicity. Statistical significance and clinical importance are separate questions. The registry provides no threshold for a clinically important change in mean weekly glucose.

The registry record gives no reported primary analyses and no detailed statistical analysis plan. It does not report whether the sponsor used an intention-to-treat population, a per-protocol population, or another analysis set. It also does not describe imputation, treatment of withdrawals, exclusions, sensitivity analyses, interim analyses, or any covariate adjustment. These omissions prevent verification of the planned analysis and make it important to keep recalculated results distinct from sponsor-reported findings.

General statistical practice distinguishes prespecified outcomes and analyses from exploratory ones. Prespecification can reduce the risk that conclusions are selected after inspecting results. The record identifies one primary endpoint and lists secondary outcomes, but the actual ordering of analyses, testing procedure, and multiplicity control are not reported. Accordingly, unadjusted comparisons can be useful descriptive summaries, but they should not be treated as a complete confirmatory analysis.

11. Confidence Intervals and Precision

The primary recalculated comparison for liraglutide 1.8mg versus placebo is -11.0 mg/dl, with a confidence interval from -12.96 to -9.04 mg/dl. For liraglutide 1.2mg versus placebo, the estimate is also -11.0 mg/dl, with a confidence interval from -14.92 to -7.08 mg/dl. Both intervals lie below zero in these recalculations. The 0.6 mg comparison is -1.3 mg/dl, with an interval from -5.22 to 2.62 mg/dl, which spans zero.

As a general explanation, an interval spanning zero indicates that the recalculated summary is compatible with no difference as well as with differences in either direction under the method's assumptions. An interval wholly on one side of zero indicates that zero is outside that particular interval, but does not resolve whether the comparison was prespecified, adjusted for multiplicity, or analyzed using the sponsor's model. The p-values likewise describe unadjusted recalculations, not certainty about a treatment effect.

Interval width is one way to assess precision: narrower intervals allow a more concentrated range of values than wider intervals. The intervals differ in width across the three comparisons, and their interpretation is limited by the small arm-specific counts and unreported details about missing outcomes and analysis methods. The registry record gives no sponsor-reported confidence intervals or analysis output for the primary comparisons. The displayed intervals should therefore be read as recalculated descriptions of uncertainty, not as a substitute for the trial's unreported primary analysis.

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 figures are planning illustrations based on the observed effect in each comparison, not the original design rationale. For these continuous outcomes, the figures are participants per arm, not total events. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is set to the stated fraction of the observed effect: 100%, 75%, or 50%.

The 80% power column gives the illustrated number of participants per arm for an 80% chance of detecting the specified effect under those assumptions, if the assumptions and effect size hold. The 90% power column gives the corresponding per-arm planning number for a 90% chance. Power is a property of a proposed design under assumed conditions; it is not a measure of how likely the observed result is true. These figures are not observed power.

Each row asks what planning would look like if the effect of interest were the observed effect or a stated fraction of it. Smaller effects are harder to distinguish from random variation, so planning for a smaller effect generally requires more participants. The values are especially sensitive to the observed effect used: unusually large estimates from small samples can yield deceptively modest planning numbers. The illustrations do not account for unreported design features, attrition, multiplicity, alternative models, or the sponsor's original assumptions. The original sample-size justification and design assumptions are not reported in the registry record.

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 = -11.000; pooled standard deviation σ = 2.646.
2. n = 2 × (1.96 + 0.842)² × 2.646² / -11.000² = 0.9, rounded up to 1 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 <- -11                      # observed difference in means
sigma <- 2.64575131106459                     # 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(1722266)
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 = 1 (80% power), 2 (90% power)
 75% of observed effect: n per arm = 2 (80% power), 3 (90% power)
 50% of observed effect: n per arm = 4 (80% power), 5 (90% power)
power.t.test: 2.4 
Simulated power at n = 1 per arm: NA (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 endpoint and multiple secondary outcomes, but it does not report how the investigators handled multiplicity. It is not reported in the registry record whether comparisons across three liraglutide doses, multiple outcomes, or repeated time points were adjusted, ordered hierarchically, or treated as exploratory. The recalculated p-values are unadjusted. When many hypotheses are tested, the chance of at least one seemingly unusual result can increase; as a general statistical principle, this is why a prespecified multiplicity strategy matters.

Missing-data handling is not reported in the registry record. The record does not describe withdrawals, reasons for missing measurements, imputation, or sensitivity analyses. It also does not identify the analysis population used for each outcome. Without this information, it is not possible to establish whether the posted outcome counts represent all randomized participants with available data, a defined subset, or another analysis set. The outcome counts differ across groups, but the registry does not explain the differences.

The registry record does not describe the primary statistical model, baseline adjustment, repeated-measures methods, or treatment of protocol deviations. It also does not report interim analyses or stopping rules. These are unknowns, not evidence that any particular practice was or was not used. Recalculated comparisons from summary statistics may not match the sponsor's analysis if the sponsor used different assumptions or a different model.

For these reasons, the posted results support a descriptive reading, with the recalculated comparisons treated as supplementary. A protocol and statistical analysis plan would be needed to evaluate whether endpoints, analysis populations, and multiplicity procedures were specified in advance. Such details are not reported in the registry record.

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 non-serious adverse event terms

The serious-adverse-event summary lists 0 affected participants in placebo, 0 in liraglutide 1.8mg, 0 in liraglutide 1.2mg, and 0 in liraglutide 0.6 mg. The corresponding numbers at risk are 17, 15, 13, and 18. These are the figures recorded for serious events in the registry outcome summary.

A count of 0 in a group means that no serious adverse event was recorded for that group in this summary; it does not demonstrate that the risk is absent. As a general statistical point, small groups and limited follow-up provide limited ability to characterize uncommon events. The registry does not provide event definitions, detailed exposure time, or information about event ascertainment in the safety summary.

Deaths are not reported in the registry record. The serious-event counts should not be confused with the separate summary of other adverse events, and they do not establish comparative safety. The record's safety information is limited to the posted counts and does not provide enough detail for broader conclusions.

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

The registry results describe average changes over the stated 12-week timeframe in the groups represented by the posted summaries. The recalculated comparisons indicate that the observed mean changes in the 1.8mg and 1.2mg liraglutide groups were lower than the placebo mean change, while the 0.6 mg comparison was smaller and less precise. Those findings characterize the recorded data; they do not establish that any dose works or does not work.

The estimates do not show how individual participants changed, whether responses were consistent, or whether any observed change was important to participants. The registry does not report a threshold for a clinically meaningful difference. Nor does a group-average result show whether the change was sustained after 12 weeks. Longer-term results are not reported in the registry record.

These results also do not establish effects on every stated study aim. The study description includes additional glucose measures, meal responses, hormonal measures, and gastric emptying, but the registry record does not provide a complete set of results for all those questions. Posted secondary outcomes offer additional descriptive context, but unadjusted analyses across multiple outcomes carry greater risk of chance findings and should be interpreted cautiously.

Finally, the recalculated comparisons are not a replacement for the sponsor's own analysis. The registry record lists no reported analyses, and important details about missing data, analytic populations, and multiplicity are not reported. The most defensible conclusion is therefore limited to the posted group summaries and their unadjusted recalculations, with uncertainty about the full analysis and the wider clinical meaning remaining.

17. Why This Trial Matters Statistically

This trial illustrates why a registry result needs to be read at more than one level. The study has a defined primary measure, a randomized parallel-group design, and several posted group summaries, yet the registry record does not give the sponsor's analysis or full statistical plan. A reader can describe what the posted means and unadjusted recalculations indicate while keeping that account distinct from a confirmatory conclusion.

It also shows the value of examining precision alongside point estimates. Two comparisons have the same recalculated mean difference, but their confidence intervals differ in width. The lower-dose comparison has a different estimate and an interval that spans zero. As a general principle, effect size and uncertainty complement one another: neither the point estimate alone nor the p-value alone captures all the information in a result.

The trial further highlights the challenges of multiple endpoints and small group summaries. The study description includes several related and distinct outcomes, but no multiplicity strategy or analysis populations are reported. This makes it important to separate a primary question from secondary or exploratory patterns and to avoid treating a collection of unadjusted findings as a single body of confirmatory evidence.

For clinical researchers, the central statistical lesson is that transparent reporting of the protocol, planned analysis, missing-data approach, and participant flow is essential to interpreting registry results. In their absence, careful descriptive interpretation is possible, but stronger claims are not supported by the record alone.

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 registry record leaves several trial-specific questions unanswered. It does not report detailed eligibility criteria, baseline participant characteristics, recruitment procedures, or the randomization and allocation-concealment methods. The broad design labels—randomized, triple-masked, parallel—do not resolve these practical details. Masking roles and procedures are also not described.

Although enrollment is recorded as 72, the arm-level counts for the posted primary outcome are not identical, and the record does not explain the differences. Reasons for missing or unavailable results, participant withdrawals, protocol deviations, and the analysis population are not reported. The reported placebo standard error for the primary outcome is 0.0; its derivation and rounding are not explained in the registry record.

The registry lists no reported analyses for the primary or secondary outcomes. It does not provide the analysis plan, baseline-adjustment method, handling of repeated measurements, multiplicity procedure, or missing-data strategy. The recalculations are therefore unadjusted summaries and may not represent the sponsor's planned method. The original sample-size rationale is also not reported; the planning illustrations based on observed effects do not establish what the trial was designed to detect.

The available outcomes cover only part of the study description, and the registry provides no longer-term primary endpoint results. Detailed safety-event descriptions and deaths are not reported in the registry record. These limitations narrow the conclusions that can be drawn from the posted summaries and prevent a full assessment of internal validity, generalizability, or the study's complete set of aims.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Liraglutide in the Treatment of Type 1 Diabetes Mellitus — NCT01722266.
• Registry record last updated 2024-01-05; status last verified 2024-01.
• Results first posted 2015-03-13.
• 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

NCT01722266 is a completed, randomized, triple-masked, parallel-group phase 3 study sponsored by the University at Buffalo. It enrolled 72 participants with type 1 diabetes and compared daily placebo with liraglutide at 0.6 mg, 1.2mg, and 1.8mg.

The primary endpoint was change in mean weekly glucose concentrations at 12 weeks. The record posts group means and standard errors and supports simple unadjusted recalculations of comparisons with placebo. The registry record lists no reported analyses, and key details about missing data, analysis populations, and multiplicity are not reported. Serious adverse event counts were 0 in each listed group; deaths are not reported in the registry record.

The results should be read as descriptions of posted summaries, not as a complete account of the sponsor's statistical analysis or the full range of study outcomes.