A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus (NCT02548585), a randomized phase 1, phase 2 study. The primary outcome is Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4).

2. Clinical Question

3. Trial Design

NCT02548585 was a randomized, quadruple-masked, parallel-group Phase 1/2 study of MEDI0382 and placebo in overweight and obese participants with type 2 diabetes mellitus. The registry lists enrollment of 113 participants and describes six cohorts with ascending doses. Participants in the active-treatment cohorts received differing dose levels and treatment schedules; the primary endpoint was evaluated in Cohort 4, where the active dose was MEDI0382 200 mcg.

The Cohort 4 regimen involved dose titration before the 200 mcg dose. The placebo group received matching placebo. The registry lists subcutaneous once-daily administration and gives cohort-specific treatment periods. Its description of the Cohort 4 placebo schedule is truncated, so the full schedule for that group is not reported in the registry record.

The study began on 2015-12-09, had primary completion on 2017-02-24, and is recorded as completed. Its stated aims included efficacy, safety and pharmacokinetics. This analysis focuses on the primary glucose endpoint, while noting selected secondary outcomes and safety data. The record does not report the original sample-size justification, target enrollment by cohort, or the rationale for the cohort sizes.

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: A total of 422 participants were screened, of which 113 participants were randomized in the study.

Only the first 6 of 7 groups are shown.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Pharmacodynamic (PD) population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.

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: As-treated Population (ATP) included all participants who received any study drug and analyzed according to the treatment they actually received.

Only the first 6 of 8 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4), measured over 0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41).

The primary endpoint was percent change from baseline in glucose area under the concentration-time curve from zero to four hours during a mixed-meal test, measured at end of treatment in Cohort 4. Area under the curve summarizes glucose measurements across the test period rather than relying on one reading. A change expressed as a percentage relates the end-of-treatment measure to the participant’s baseline measure.

For the test, participants consumed a standardized meal within five minutes. Blood samples were collected before the meal and at scheduled times through 240 minutes afterward. The registry describes the test as including measurements just before and up to four hours after the meal, with no additional food intake during that period. Baseline testing occurred on Day -1 and end-of-treatment testing on Day 41.

This kind of endpoint can capture the overall glucose response to a meal challenge. It is a pharmacodynamic measure, not by itself a direct measure of longer-term clinical outcomes. The registry identifies the analysis population as participants who received at least one dose and had at least one post-MMT pharmacodynamic blood sample. A threshold for a clinically important change is not reported in the registry record.

7. Results Posted in the Registry

• Cohort 4: MEDI0382 200 mcg: mean -33.81 versus -9.24 on control; difference -24.57 (95% CI -33.27 to -15.87), standardized effect d = -1.56; z-test p = <0.001.

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.

Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)

• 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:
  • Cohort 4: MEDI0382 200 mcg: mean -0.92 versus -0.58 on control; difference -0.34 (95% CI -0.54 to -0.14), standardized effect d = -0.95; z-test p = <0.001.
  • Cohort 5: MEDI0382 300 mcg: mean -0.55 versus -0.58 on control; difference 0.03 (95% CI -0.21 to 0.27), standardized effect d = 0.10; z-test p = 0.804.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Cohort 4: MEDI0382 200 mcg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cohort 5: MEDI0382 300 mcg and the control. The interval gives the range of effects that remain compatible with the data.

Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)

• 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:
  • Cohort 4: MEDI0382 200 mcg: mean -67.90 versus -33.70 on control; difference -34.20 (95% CI -58.63 to -9.77), standardized effect d = -0.77; z-test p = 0.006.
  • Cohort 5: MEDI0382 300 mcg: mean -47.40 versus -33.70 on control; difference -13.70 (95% CI -33.19 to 5.79), standardized effect d = -0.35; z-test p = 0.168.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Cohort 4: MEDI0382 200 mcg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cohort 5: MEDI0382 300 mcg and the control. The interval gives the range of effects that remain compatible with the data.

The secondary measures span meal-test glucose, body weight, longer-term glycemic markers, fasting glucose, fructosamine, and safety outcomes. This range provides context around the primary pharmacodynamic question, but each endpoint measures a different aspect of response and may have a different timeframe and available cohort population.

In the posted continuous summaries, Cohort 4 results for HbA1c and fructosamine are directionally consistent with the primary glucose endpoint, while the available Cohort 5 comparisons are less decisive. The Cohort 6 arm summaries are also listed for those measures, but no recalculated Cohort 6 comparison is included in the posted analysis data. These secondary observations do not establish that the primary result translates into a longer-term or clinically important effect.

The registry lists 24 secondary outcome measures, while the detailed results represented in the posted data cover selected measures. The registry record does not report a multiplicity adjustment plan. When many outcomes and comparisons are examined, the chance of at least one apparently notable result arising by chance can increase. Unadjusted secondary results therefore carry less weight than a prespecified primary comparison and should be treated as supportive or exploratory. The full analysis plan and the approach to controlling multiplicity are not reported in the registry record.

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

• Percent Change From Baseline in MMT Glucose AUC0-4h to the EOT (Cohorts 1, 2, 3, 5, and 6)
• Change From Baseline in Body Weight to the EOT (Cohorts 1, 2, 3, 5, and 6)
• Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)
• Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)
• Change From Baseline in Fasting Glucose Prior to MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)
• Percent Change From Baseline in Glucose Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) After MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
• Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is a continuous measure, and the registry reports group means and standard deviations. A mean describes the group’s average endpoint value; the standard deviation describes how spread out individual values are around that average. The reported means are changes from baseline, so their signs and magnitudes describe the direction and average size of change on the endpoint’s scale.

The recalculated comparison subtracts the placebo mean from the MEDI0382 mean using the posted group summaries. It is a simple unadjusted comparison, not a reconstruction of the sponsor’s participant-level model. The recalculated mean difference is -24.57, with a 95% confidence interval from -33.27 to -15.87 and p < 0.001. These statistics are calculated from the Cohort 4 summary values and are not adjusted for baseline covariates or other factors.

The sponsor’s reported analysis is an ANCOVA superiority analysis, with p < 0.001. ANCOVA, or analysis of covariance, compares groups while accounting for one or more covariates in a statistical model. The registry does not state which covariates were included, how the model was specified, or how missing endpoint values were handled. Consequently, the sponsor analysis cannot be reproduced from the arm means and standard deviations alone. The sponsor’s own analysis takes precedence over the recalculation because it is the reported trial analysis.

What does a confidence interval express?

A confidence interval expresses uncertainty about an estimated effect. It gives a range of effect values compatible with the data and the method’s assumptions. A narrower interval indicates greater precision than a wider interval, but neither interval width nor statistical significance tells whether an effect is important to participants. Interpretation also depends on the endpoint’s scale and on a clinical-importance threshold, which is not reported in the registry record.

What does a p-value tell the reader?

A p-value measures how compatible the observed data are with a specified null hypothesis under 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 an effect. The recalculated p-value is unadjusted. The sponsor reports an ANCOVA p-value separately, so the two results arise from different analysis approaches and should not be treated as identical calculations.

Why do design and analysis populations matter?

Randomization is intended to create comparable groups at allocation, while masking can reduce the influence of expectations on care, measurement and reporting. The study is recorded as randomized and quadruple-masked, but further details about randomization procedures and which roles were masked are not reported in the registry record. The primary analysis population is defined by treatment received and availability of a post-MMT sample. This is not necessarily the same as an analysis of every randomized participant. The registry does not describe the number excluded from the primary analysis or the reasons for any exclusions.

The study used a parallel-group design, meaning participants were assigned to a study group rather than serving as their own control across treatment periods. Six cohorts allowed evaluation of ascending dose schedules, but cohort-specific sizes varied. The primary endpoint comparison is confined to Cohort 4 and should not be interpreted as a pooled estimate across all six cohorts.

Why can over-dispersion matter?

For a continuous endpoint, variability affects how precisely a group mean and a between-group difference can be estimated. If individual responses vary substantially, the mean difference is less precise for a given group size. The posted standard deviations describe variability in the endpoint, but they do not reveal its distribution or whether model assumptions were checked. The record does not report diagnostic checks, transformations, robust methods or other handling of departures from model assumptions. General statistical practice is to consider such features when choosing and assessing a model, but the registry record does not say what checks were performed.

The planning illustrations use a normal approximation and equal allocation between two groups, with a two-sided significance level of 0.05. Their assumed effect is a stated fraction of the observed effect. These are hypothetical planning calculations from the observed summary effect, not the trial’s original design calculations. The trial’s sample-size justification and original design assumptions are not reported in the registry record.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -24.57, with a 95% confidence interval from -33.27 to -15.87. The interval lies on the negative side of zero and describes uncertainty around the unadjusted difference between the Cohort 4 group means. Its endpoints indicate that the data and calculation are compatible with a range of negative differences, rather than identifying one exact effect size.

The interval’s precision is affected by the observed variability and the analyzed group sizes: 26 participants in the placebo group and 25 in the MEDI0382 group. The reported standard deviations are 12.3 and 18.62. A confidence interval is not a range expected to contain every participant’s response, nor does it measure the probability that a particular effect is true. It quantifies uncertainty in the estimated group difference under the calculation’s assumptions.

The sponsor’s ANCOVA result is reported as p < 0.001, but the registry supplies no corresponding adjusted effect estimate or confidence interval. Therefore, the precision of the sponsor-adjusted effect cannot be assessed from the reported analysis result alone. The unadjusted recalculated interval should not be substituted for an unavailable ANCOVA interval.

Precision also differs across secondary comparisons, especially where the group sizes are smaller. Their estimates and intervals should be read with their cohort sizes in mind. No clinical-importance boundary is reported, so the confidence interval cannot be classified as excluding effects that are too small to matter clinically.

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 illustrations express required participants per arm for comparisons of two groups. They are not total event counts: the event-count convention applies to time-to-event outcomes, and the primary endpoint is continuous. The calculations assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses a stated fraction of the observed effect as the effect to detect.

The 80% power column represents the planned chance of detecting the assumed effect under the calculation’s assumptions if that effect is real. The 90% column uses a higher target chance of detection. These are planning targets, not guarantees for a future study. The illustrations are based on observed effects and are not observed power.

Each row changes the assumed effect size. Planning for a smaller effect requires more participants per arm to achieve the same target power, because a smaller difference is harder to distinguish from random variation. The estimates should be interpreted as illustrations rather than as recommendations or as the sample size used in this trial. The trial’s original sample-size justification, planned power, 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 = -24.570; pooled standard deviation σ = 15.716.
2. n = 2 × (1.96 + 0.842)² × 15.716² / -24.570² = 6.4, rounded up to 7 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 <- -24.57                      # observed difference in means
sigma <- 15.7163346716149                     # 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(2548585)
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 = 7 (80% power), 9 (90% power)
 75% of observed effect: n per arm = 12 (80% power), 16 (90% power)
 50% of observed effect: n per arm = 26 (80% power), 35 (90% power)
power.t.test: 7.5 
Simulated power at n = 7 per arm: 0.768 (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. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary comparison as an ANCOVA superiority analysis with p < 0.001. It does not report the ANCOVA effect estimate, confidence interval, covariates, or full model specification. That reported result is the trial’s own analysis and takes precedence over the simple unadjusted recalculation.

The recalculation uses the posted Cohort 4 means, standard deviations and group sizes to estimate an unadjusted mean difference of -24.57, with a 95% confidence interval from -33.27 to -15.87 and p < 0.001. It is a transparent summary-statistics comparison, but it cannot account for any covariate adjustment or other modeling choices used by the sponsor. The results are directionally consistent in showing a difference favoring a larger reduction in the MEDI0382 group on this endpoint, but they are not interchangeable analyses.

The registry does not report enough detail to determine whether the sponsor model used baseline endpoint values or other covariates, or how it treated missing observations. Those details would be needed for a fuller assessment of the reported ANCOVA result.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates several outcomes, groups or comparisons. Even if each analysis uses a conventional significance threshold, testing many hypotheses can increase the chance of false-positive findings across the full set. This study includes six cohorts, ascending dose schedules, a primary endpoint and a broad set of secondary outcomes. Those features make it important to know which analyses were confirmatory and whether any adjustment or hierarchical testing strategy was planned.

The registry record does not report a multiplicity adjustment method, testing hierarchy, interim-analysis plan, or a complete statistical analysis plan. It is therefore not possible to determine from the record whether the sponsor controlled the overall type I error rate across endpoints and cohorts. The primary comparison has a reported sponsor ANCOVA p-value; the secondary recalculated p-values are unadjusted and should not be interpreted as if they had been corrected for multiple testing.

Missing-data handling is also not reported in the registry record. The primary pharmacodynamic population required at least one dose and at least one post-MMT pharmacodynamic blood sample. The record does not specify how participants without an endpoint measurement were handled, whether any values were imputed, or whether sensitivity analyses assessed the effect of missing observations. It also does not give a count of randomized participants excluded from the primary endpoint analysis.

The distinction between the randomized population and the endpoint population matters because exclusions after randomization can affect comparability. Without participant flow and missing-data details, readers cannot assess how much the analysis population differed from the randomized groups or how robust the estimates are to missing outcomes.

16. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia mycoplasmal (14.3%), diplopia (3.8%).

Serious adverse events were reported by cohort and treatment group. In Cohort 4, one of 26 placebo participants had a serious adverse event, compared with none of the 25 participants receiving MEDI0382 200 mcg. In Cohort 3, one of seven MEDI0382 participants had a serious adverse event; no serious events were reported in the other listed groups. The registry lists no deaths in any group.

These counts are descriptive. Small group sizes mean that a count of zero does not establish that an event cannot occur, and counts alone do not provide a reliable estimate of comparative risk. The registry also lists pneumonia mycoplasmal and diplopia among serious-event terms, with percentages of 14.3% and 3.8%, respectively; the record excerpt does not clarify their denominators or provide enough context to interpret those percentages as treatment-specific rates.

Other treatment-emergent adverse events were reported in most groups, but those counts are not the same as serious adverse events. The available summaries do not establish causality or support a broad comparative safety conclusion.

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

The posted primary endpoint data show a difference in mean percent change in mixed-meal glucose area under the curve between Cohort 4 participants assigned to MEDI0382 200 mcg and those assigned to placebo. The unadjusted recalculation estimates a mean difference of -24.57, with a 95% confidence interval from -33.27 to -15.87. The sponsor’s own analysis reports an ANCOVA superiority result with p < 0.001.

This finding applies to a specific pharmacodynamic measure, cohort, dose schedule and end-of-treatment assessment. It does not by itself establish effects on longer-term outcomes, nor does it establish the size of any clinically important benefit. The registry record does not provide a clinical-importance threshold or the adjusted effect estimate from the sponsor’s ANCOVA.

The study also reports secondary outcomes and adverse events, but the size of the cohorts and the number of outcomes limit the strength of broad conclusions from these summaries. Secondary comparisons are unadjusted in the recalculation, and the multiplicity plan is not reported. Safety counts are descriptive and do not establish that treatment caused or did not cause an event.

Statistical evidence, clinical importance and overall benefit-risk assessment are different questions. The posted results inform the first question for the primary endpoint, but the record alone does not resolve the latter questions. The findings should be understood as results from a Phase 1/2 multiple-ascending-dose study, not as evidence for every dose, population, treatment duration or clinical setting.

18. Why This Trial Matters Statistically

This trial illustrates why the analysis population, endpoint definition and treatment cohort matter when interpreting a randomized study. The primary comparison concerns Cohort 4 and a four-hour meal-test glucose measure, not a pooled estimate across all ascending-dose cohorts. Keeping the result tied to its cohort and measurement helps prevent inappropriate generalization.

It also demonstrates the distinction between an adjusted sponsor analysis and a simple recalculation from group summaries. Both are based on the same study comparison, but the available registry information does not show the sponsor model’s estimate or covariates. The recalculation is useful for understanding the group means and the unadjusted contrast, while the sponsor’s reported analysis remains the trial analysis.

Finally, the record highlights the value of complete reporting. A multiplicity plan, missing-data methods, model details and original sample-size rationale would help readers assess the strength and precision of the evidence. Without those details, secondary findings and planning illustrations need cautious interpretation. The trial’s broad set of pharmacodynamic, metabolic and safety outcomes makes these distinctions especially relevant.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary endpoint analysis is limited to Cohort 4, and the registry’s primary analysis population includes participants with at least one post-MMT sample rather than explicitly defining an all-randomized population. The number of participants excluded from that population and the reasons for exclusion are not reported in the registry record. Missing-data methods and sensitivity analyses are also not reported.

The sponsor’s ANCOVA result is reported without an adjusted effect estimate, confidence interval, covariate list or model specification. The recalculated comparison is unadjusted and cannot reproduce that model. The record also does not report the original sample-size justification or the planned allocation and power assumptions for each cohort.

Interpretation of secondary outcomes is constrained by the many endpoints and cohorts, the absence of a reported multiplicity plan, and the limited size of some cohort groups. The record does not provide a clinical-importance threshold for the primary endpoint. For safety, the group counts are descriptive, and the context and denominators for the listed serious-event percentages are not clear in the available record.

The study’s ascending-dose schedules and differing treatment durations mean results across cohorts are not simple replications of the Cohort 4 comparison. The primary result should therefore remain specific to the dose, cohort, endpoint and timeframe assessed.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus — NCT02548585.
• Registry record last updated 2019-04-05; status last verified 2019-01.
• Results first posted 2019-04-05.
• 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.

23. Record Summary

NCT02548585 is recorded as a completed randomized, quadruple-masked, parallel-group Phase 1/2 study of MEDI0382 and placebo in overweight and obese participants with type 2 diabetes mellitus. Enrollment was 113, and the study included six ascending-dose cohorts.

The primary endpoint assessed percent change from baseline in mixed-meal glucose area under the curve from zero to four hours at end of treatment in Cohort 4. The sponsor reported an ANCOVA superiority analysis with p < 0.001. A summary-statistics recalculation estimated an unadjusted mean difference of -24.57, with a 95% confidence interval from -33.27 to -15.87.

The record includes secondary outcome and adverse-event results. Details on the original sample-size rationale, multiplicity plan, missing-data handling and full sponsor model are not reported in the registry record.