This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects (NCT02750930), a na phase 4 study. The primary outcome is Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02750930 |
| Phase | Phase 4 |
| Condition | Diabetes Mellitus, Type 2 |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Participants with type 2 diabetes mellitus who entered an extension study after Study 200952. The primary endpoint population is defined as enrolled participants who received at least 1 dose of study medication. The registry reports 8 enrolled participants.
Intervention
Albiglutide liquid drug product, administered once weekly by auto-injector for the planned 26-week treatment period. The arm description specifies 50 milligrams (mg) per dose.
Comparator
There is no comparator group in this single-group, open-label extension. The registry lists allocation as not applicable and does not describe a randomized comparison.
Primary question
How many participants had adverse events (AEs) or serious adverse events (SAEs) during the extension or had ongoing events from Study 200952, with reporting through Week 34?
The study was designed to collect extended safety, tolerability and immunogenicity information for the liquid drug product. Its primary endpoint is a count of participants with AEs and SAEs, rather than a comparison of event rates between treatments. The registry describes an extension of Study 200952, so the primary endpoint also includes ongoing AEs or SAEs from that earlier study.
The posted record reports 2 participants with other adverse events and 0 with serious adverse events among the 8 at risk in the Albiglutide Liquid group. It also reports 0 deaths. These counts describe the participants recorded in this extension; with no comparator group, they do not estimate a treatment difference. The registry does not report a separate efficacy question or an efficacy outcome analysis for this record.
3. Trial Design
This is a Phase 4, open-label, single-group, multicenter extension study of albiglutide liquid drug product in people with type 2 diabetes mellitus. Its title and summary describe it as an extension to Study 200952. The registry lists the allocation as not applicable and masking as none. There is no randomized control group in this record.
The planned treatment period was 26 weeks, followed by an 8-week post-treatment follow-up period. The arm description says participants would receive 50 milligrams (mg) of albiglutide once weekly through an auto-injector for 26 weeks. The registry lists albiglutide as the drug intervention and an auto-injector as the device. The maximum number of eligible participants described in the study summary was 300; the recorded enrollment was 8.
The primary endpoint timeframe is reported as up to Week 34. The registry states that the endpoint count includes participants reporting an AE or SAE during the extension, as well as participants with an ongoing AE or SAE from Study 200952. The Safety Population is defined as all enrolled participants who received at least 1 dose of study medication.
The record lists a start date of 2016-10-07 and a primary completion date of 2017-03-21. The overall status is terminated. The reason for termination and further information about the conduct of the extension are not reported in the registry record. The record does not state how participants entered the extension, how many completed treatment, or how many completed follow-up. Those details should not be inferred from the stated study plan or the enrollment count.
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: The participants who completed study 200952 and who were eligible, were included in this open-label extension study 204682. This was an extension study, hence visit 1 of this study was also a last treatment visit of study 200952 (NCT02683746).
Overall Study
| Stage | Albiglutide Liquid |
|---|---|
| STARTED | 8 |
| COMPLETED | 0 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Albiglutide Liquid |
|---|---|
| Study closed/terminated | 8 |
Analysis population for the primary outcome, as defined in the registry: Safety Population comprised of all enrolled participants who received at least 1 dose of study medication.
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.
| Characteristic | Unit | Albiglutide Liquid |
|---|---|---|
| Participants analysed | 8 | |
| Age, Continuous | Years | 53.1 (SD 7.86) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 5 |
| Race/Ethnicity, Customized: White | Participants | 7 |
| Race/Ethnicity, Customized: American Indian or Alaskan native | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), measured over Up to Week 34.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events (AEs) and serious adverse events (SAEs), reported through Week 34. An AE is defined broadly in the registry as an untoward medical occurrence after administration of a pharmaceutical product, whether or not considered related to the drug. The definition includes events such as side effects, injury, toxicity, sensitivity reactions, abnormal or worsening laboratory values, concurrent illness, and sudden death. A pre-existing condition that worsens during the study is also counted as an AE.
An SAE is an AE meeting one or more specified seriousness criteria, including death, a life-threatening event, inpatient hospitalization or extension of a hospital stay, significant or ongoing incapacity, substantial interference with normal life functions, a congenital anomaly or birth defect, or an event associated with liver injury or impaired liver function. The endpoint description says it includes events during this extension and ongoing events from Study 200952.
Counting participants with events is a way to describe how many people experienced an event, rather than how many separate episodes occurred. This endpoint is used to characterize safety and tolerability over the stated observation period. It does not by itself establish whether an event was caused by treatment, and it does not compare risk against an untreated or alternative-treatment group. The registry does not report event-level timing, severity breakdowns, or causal assessments for the two participants with other AEs.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 8 participants at risk for serious adverse events in the Albiglutide Liquid group, with 0 participants affected. For other adverse events, 8 participants were at risk and 2 were affected. The record also reports 0 deaths. These are counts from a small, single-group extension, and they are descriptive observations rather than estimates of a contrast between treatments.
The endpoint combines different kinds of medical occurrences under the AE definition, whether or not considered related to study medication. The posted summary does not identify the specific events experienced by the 2 participants, their timing, whether they were considered treatment-related, or whether they were ongoing from Study 200952. It therefore does not support a more detailed account of the types or causes of those events. The serious-event count is reported as zero, but the absence of recorded SAEs among this group does not establish that serious events cannot occur.
Precision is an important consideration. In general, counts from a small group provide limited information about the range of outcomes that might occur in a broader population. With no comparator group, the observed counts cannot distinguish events associated with the intervention from events that might occur without it or under another treatment. No inferential analysis is reported for the primary endpoint in the registry record, and the record does not provide confidence intervals for these counts.
The status is terminated, while the registry lists 8 participants enrolled and describes a planned treatment period and follow-up period. It does not report why the study was terminated, how many participants received treatment, how many completed follow-up, or whether the stated observation period was completed by every participant. The endpoint timeframe is up to Week 34, but that does not establish that all participants were observed for that full period.
Overall, the posted data describe adverse-event counts in the participants represented in this extension record. They do not establish comparative safety, quantify a treatment effect, or answer an efficacy question. Interpretation is constrained by the absence of a control group, the limited enrollment, and missing details about event types, exposure, follow-up, and analysis.
9. Statistical Methods Explained
The primary outcome is a binary participant-level event measure summarized as a count: whether a participant was recorded as having an AE or SAE during the specified period. The record also presents separate safety counts for serious events and other events. This format describes the number of people with events; it is not a count of all event episodes. The registry does not report an inferential analysis of these counts.
What a participant count describes
For a participant-level endpoint, each person is classified according to whether the event definition was met. A count is easy to interpret as a description of the observed group, but it does not convey event duration, recurrence, severity beyond the stated SAE classification, or the time at which an event occurred. Those details are not reported for the two participants with other AEs. The number of participants at risk is also important context because the count is tied to the group observed, not to a larger population automatically.
In general, a confidence interval expresses the uncertainty around an estimate under a statistical model. It can help distinguish a precisely estimated quantity from one with substantial uncertainty. The registry record does not report confidence intervals for the primary event counts, so no interval-based precision estimate is available for these results. A zero count should be read as no events recorded in the observed group, not as proof that the underlying event probability is zero.
Why a comparison is not available
The record describes a single-group, open-label study and lists allocation as not applicable. There is no randomized comparator in the reported design. In general, a treatment comparison requires results from groups that can be contrasted under a defined analysis. A single-group count can describe what occurred during observation, but it cannot isolate the effect of treatment from other influences or establish what would have happened to the same participants under another treatment.
The study is an extension of Study 200952, and the endpoint may include ongoing events from that study. This makes the endpoint a description of events during the extension or continuing from the preceding study, according to the registry definition. The record does not give a separate breakdown of newly occurring and ongoing events, nor does it report the earlier study's relevant counts for comparison. No adjusted analysis or model is reported.
Analysis plans and multiplicity
The registry lists 9 outcome measures and 0 analyses. It does not report the statistical analysis plan for the primary endpoint, any hypothesis test, or any adjustment for multiple outcomes. In general, multiplicity concerns arise when several outcomes or comparisons are tested, because the chance of at least one false-positive result may increase across a set of tests. Whether or how that issue was addressed in the study is not reported in the registry record. The presence of multiple outcome measures alone does not show that formal testing was conducted.
Planning illustrations are not trial results
Any sample-size calculations associated with the posted results are planning illustrations, not observed power. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Time-to-event illustrations use total events; other illustrations express participants per arm. These hypothetical assumptions do not describe the actual single-group extension, which has no two-arm randomized comparison. They should not be interpreted as the trial's own design justification or as evidence that the study had a particular probability of detecting an effect.
In general, over-dispersion matters when outcome variability is greater than a statistical model assumes, because standard errors and uncertainty estimates may then be understated if the extra variability is ignored. The endpoint is reported as participant counts, and the registry does not report a model-based analysis or a dispersion assessment. It would therefore be inappropriate to claim that over-dispersion was tested or addressed in this study.
Missing information and scope
The Safety Population includes all enrolled participants who received at least 1 dose. The registry does not report the number who received a dose, the number with evaluable follow-up, or how missing endpoint data were handled. It also does not report an imputation method, sensitivity analysis, or analysis by treatment exposure. Without those details, the recorded counts can be described, but the completeness of event ascertainment across all enrolled participants cannot be assessed from this record alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies 9 outcome measures but lists 0 analyses. It does not report a statistical analysis plan explaining which outcomes were intended for formal hypothesis testing, whether any comparisons were planned, or whether an adjustment for multiple testing was specified. In general, multiplicity adjustment is relevant when a family of statistical tests is used and a study seeks to control the chance of false-positive findings across that family. The registry record does not establish that such testing or adjustment occurred.
The primary endpoint population is described as all enrolled participants who received at least 1 dose of study medication. The posted safety counts list 8 participants at risk in the Albiglutide Liquid group. The record does not separately state how many enrolled participants received a dose, how many were included in each endpoint analysis, or whether all participants contributed complete follow-up through Week 34.
Missing-data handling is not reported in the registry record. There is no description of how participants with incomplete follow-up, withdrawal, or missing event information were treated in the endpoint summaries. No imputation approach or sensitivity analysis is reported. Consequently, the extent to which the counts reflect complete observation for every participant cannot be determined from the registry information.
Because the design has one group and no randomized comparator, multiplicity procedures would not resolve the central limitation that the results are not comparative. The posted endpoint counts remain descriptive, and no inferential analysis is reported for them.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Albiglutide Liquid | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Albiglutide Liquid | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Albiglutide Liquid | 2 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Albiglutide Liquid |
|---|---|---|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | 1 of 8 |
| Vitamin D deficiency | Metabolism and nutrition disorders | 1 of 8 |
| Tooth abscess | Infections and infestations | 1 of 8 |
The registry reports 0 participants with serious adverse events among 8 at risk in the Albiglutide Liquid group. It reports 2 participants with other adverse events among 8 at risk, and 0 deaths. These are participant counts, not counts of all event episodes. The endpoint timeframe is up to Week 34 and includes events during the extension or ongoing events from Study 200952.
The AE definition includes occurrences whether or not considered related to study medication. The record does not identify the specific events among the 2 participants, describe their severity, or state whether they were considered treatment-related. It also does not separate new events from events ongoing at entry from Study 200952. The zero SAE count therefore means that no participant was recorded with an SAE in the reported group and endpoint summary; it does not show that serious events are impossible or that the treatment has no serious risks.
These figures come from a single-group extension with 8 enrolled participants, not a comparison against another treatment or a control group. The registry does not report whether each participant completed the full follow-up period. The counts should be read as a limited description of the safety observations recorded, not as a comparative safety estimate or a complete characterization of event risk.
12. What the Result Does, and Does Not, Mean
The posted results describe the safety observations recorded in a small extension group: 2 participants had other adverse events, 0 had serious adverse events, and 0 deaths were reported. These figures are counts, not estimates of differences between treatments. The record gives no comparator group and no inferential analysis for the primary endpoint.
The event definitions are broad, and the record says that an AE need not be considered related to the drug. The counts therefore do not establish that the study medication caused the events, nor do they establish that events were unrelated. The specific events, their timing, and their attribution are not reported. The registry also does not state how many participants completed the planned treatment or post-treatment follow-up.
The absence of a reported SAE in this group is not evidence that serious events cannot occur. General statistical reasoning is that observations from a small group leave considerable uncertainty about how outcomes may vary in a wider population. The registry record does not provide a confidence interval or another quantified estimate of that uncertainty. The counts should not be interpreted as demonstrating safety or lack of safety relative to another option.
The study was designed as an extension to collect longer-term safety, tolerability, and immunogenicity information, but the posted primary result addressed AEs and SAEs. No efficacy conclusion can be drawn from these safety counts. The registry records the study as terminated, but the reason is not reported in the registry record. The termination status and enrollment count alone do not explain the completeness or representativeness of the observations.
In short, the results answer a narrow descriptive question about recorded events in the participants included in the extension summary. They do not establish comparative effects, causation, or the frequency of events in a broader population.
13. Why This Trial Matters Statistically
This record illustrates the difference between collecting safety observations and estimating a comparative treatment effect. A single-group extension can document events experienced during a period of continued study participation. Without a control group, however, the event counts cannot be contrasted with outcomes under another treatment or without treatment. The design therefore sets a clear limit on the statistical questions the posted results can answer.
The endpoint also shows why definitions and observation windows matter. The registry defines AEs broadly, includes events regardless of whether they are considered drug-related, and permits ongoing events from Study 200952 to contribute. It reports the primary endpoint through Week 34. Those details shape what the counts mean; they are not simply a list of events newly arising after the extension began.
The record reports only 8 enrolled participants, while the study summary describes a maximum of 300 eligible participants. The difference between a planned maximum and recorded enrollment is important context for interpreting the observed counts. The registry does not explain why enrollment was limited or why the study was terminated, so those reasons should not be inferred.
Finally, the record lists outcome measures but no analyses and does not describe missing-data handling or confidence intervals for the primary endpoint. This is a reminder that raw event counts and a study's inferential conclusions are not interchangeable. Readers can understand what was recorded, while recognizing that precision, completeness, and comparative interpretation are not established by the available registry information.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The design is open-label and single-group, with no randomized comparator. This prevents a direct comparison of AE or SAE counts between treatment groups and limits interpretation to a description of the reported participants. The study's allocation is listed as not applicable, and the registry does not report a separate control group.
Enrollment was 8, while the study summary described a maximum of 300 eligible participants. The small enrollment limits the amount of safety experience represented by the posted counts. The registry does not explain the difference between the maximum described and actual enrollment, or why the study was terminated. The reason for termination is not reported in the registry record.
The endpoint includes events during the extension as well as ongoing events from Study 200952. The record does not provide an event-level listing, a breakdown of new versus ongoing events, severity details for other AEs, or attribution to treatment. It also does not report the number of participants who completed treatment or the post-treatment follow-up period, so completeness of observation through Week 34 cannot be established.
The registry does not report confidence intervals, inferential tests, a statistical analysis plan, missing-data methods, or sensitivity analyses for the primary endpoint. It defines the Safety Population as participants who received at least 1 dose but does not separately report the number dosed. These gaps constrain assessment of precision, endpoint completeness, and analysis choices. The registry's status and dates do not resolve those uncertainties.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects — NCT02750930.
- Registry record last updated 2019-07-12; status last verified 2019-07.
- Results first posted 2018-03-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This Phase 4 study is an open-label, single-group extension to Study 200952 in people with type 2 diabetes mellitus. It was designed to collect extended safety, tolerability, and immunogenicity information for albiglutide liquid drug product. The planned regimen was 50 milligrams (mg) once weekly by auto-injector for 26 weeks, followed by an 8-week post-treatment follow-up period.
The registry reports 8 enrolled participants and lists the study status as terminated. The primary endpoint counts participants with AEs or SAEs through Week 34, including ongoing events from Study 200952. The posted safety summary reports 2 participants with other AEs, 0 with SAEs, and 0 deaths. The record does not report a comparator, an inferential analysis, the reason for termination, or how missing follow-up information was handled.