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 A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005) (NCT00511667), a randomized phase 1 study. The primary outcome is Participants With Any Clinical Adverse Experience.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00511667 |
| Phase | Phase 1 |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 70 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants with type 2 diabetes mellitus. The study description includes participants with or without adequate control on metformin, but the number in each metformin-control category is not reported in the registry record.
Intervention
Multiple daily doses of investigational MK-0941, described in the official title as administration before each meal. The arm-specific dose schedule and participant counts by dose are not reported in the registry record.
Comparator
Placebo, assigned within a randomized, double-blind study. The registry lists 18 participants in the placebo arm and 52 in the MK-0941 arm.
Primary question
Was multiple daily MK-0941 sufficiently safe and well tolerated to permit continued clinical investigation? The registry identifies participants with any clinical adverse experience as the primary outcome, assessed approximately 30 days after the last study-drug dose, with a shorter stated follow-up of 14 days for participants receiving MK0941 40 mg before each meal.
This is a safety and pharmacology question, not a question about whether MK-0941 improves diabetes control. The registry describes the study’s primary hypotheses in terms of safety and tolerability among participants with type 2 diabetes, including those with or without adequate control on metformin. The secondary outcomes focus on drug concentrations over time after repeated dosing. Together, those objectives describe an early investigation of tolerability and pharmacokinetics. The posted primary outcome is a count-based measure: whether participants experienced any clinical adverse experience during the specified follow-up. The record does not report a formal statistical test comparing the two groups for that endpoint, so the arm-specific percentages describe the posted results without establishing whether the observed difference is compatible with chance variation or represents a reliable between-group effect.
3. Trial Design
The registry describes a completed Phase 1 study with randomized allocation, double masking, and a parallel-group model. Its official title identifies a multicenter, placebo-controlled, sequential-panel study. These design features frame the results: participants were assigned to MK-0941 or placebo, and the study was intended to assess safety, tolerability, pharmacokinetics, and pharmacodynamics after multiple daily administration. The record lists an enrollment of 70, with 52 participants in the MK-0941 group and 18 in the placebo group.
The stated treatment schedule was administration of MK-0941 before each meal. The registry’s intervention list names MK0941 and placebo, but the arm descriptions are blank. It therefore does not report the full dose allocation across panels, the number of participants assigned to each dose, or how the sequential panels were organized. The title and primary-outcome timeframe mention MK0941 40 mg before each meal, but that does not establish the allocation of participants across all dose groups.
The study started in 2007-05, reached primary completion in 2008-04, and is recorded as completed. The registry identifies type 2 diabetes mellitus as the condition. It does not report a fuller description of eligibility criteria, the randomization procedure, concealment of allocation, or the details of the masking process. Those omissions limit the extent to which the design can be independently reconstructed from the registry record.
Although the overall study is described as parallel, the intervention and arm information posted for the results presents a single MK-0941 group and a placebo group. It is not possible to determine from the available arm descriptions whether the MK-0941 results pool multiple dose panels. The reported enrollment and arm sizes describe the posted groups; they do not, by themselves, establish whether all enrolled participants completed treatment or were included in each outcome analysis.
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
| Stage | MK-0941 | Placebo |
|---|---|---|
| STARTED | 52 | 18 |
| COMPLETED | 40 | 15 |
| NOT COMPLETED | 12 | 3 |
Reasons for not completing this period:
| Reason | MK-0941 | Placebo |
|---|---|---|
| Adverse Event | 1 | 0 |
| Protocol Violation | 1 | 1 |
| Withdrawal by Subject | 2 | 0 |
| Site terminated | 6 | 1 |
| Other | 2 | 1 |
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 | MK-0941 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 52 | 18 | 70 | |
| Age, Customized: 29 to 70 years | participants | 52 | 18 | 70 |
| Sex: Female, Male: Female | Participants | 23 | 10 | 33 |
| Sex: Female, Male: Male | Participants | 29 | 8 | 37 |
6. Primary Endpoint
The registry lists the primary outcome as Participants With Any Clinical Adverse Experience, measured over Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of of participants |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of participants with any clinical adverse experience, presented as a percentage of participants. It is a participant-level summary: the outcome indicates whether an individual had at least one clinical adverse experience during the specified observation period. It does not convey how many separate experiences an affected participant had, how long they lasted, or their severity unless those details are reported separately.
The registry states that assessment took place approximately 30 days after the last dose of study drug, with 14 days specified for participants receiving MK0941 40 mg before each meal. This follow-up window is part of the endpoint definition and should be kept in mind when interpreting the reported proportions. It does not describe longer-term safety after that period.
General statistical context: a measure of participants with any adverse experience is commonly used in safety assessment because it gives a direct summary of how many participants experienced at least one event. It is a broad measure, however. Events can differ in type, severity, duration, and clinical importance, and a single participant counts once in this endpoint even if they experienced multiple events. Separate event-level or severity-specific results are needed to understand those distinctions.
The registry reports 51.9% for MK-0941 and 61.1% for placebo. It does not report confidence intervals, a p-value, or an adjusted comparison for this primary endpoint. The percentages therefore describe the recorded group outcomes, not a demonstrated treatment difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome reports that 51.9% of participants in the MK-0941 group and 61.1% of participants in the placebo group had any clinical adverse experience. The group sizes are 52 and 18, respectively. These values describe the proportions recorded in the two arms during the stated follow-up period. They should not be read as a formal test of whether the groups differed, because the registry does not report an inferential comparison for this count-based endpoint.
The unequal group sizes matter when considering how much information each percentage represents. The placebo estimate is based on a smaller group than the MK-0941 estimate, so it may be less precise. The registry does not provide confidence intervals to quantify the uncertainty around either percentage. General statistical context: a confidence interval expresses a range of values compatible with the observed data under a specified method. Without such intervals or a reported test, the precision of the arm-specific estimates cannot be judged from the percentages alone.
The registry also reports 27 participants with other adverse experiences in the MK-0941 group and 11 in the placebo group. These counts appear in the adverse-event information, alongside zero serious adverse experiences in each group. These event summaries are not a substitute for the primary endpoint’s inferential analysis. The registry’s outcome label refers to any clinical adverse experience, while the adverse-event groups separately distinguish serious from other experiences. The record does not describe the relationship between these outcome presentations in enough detail to infer that they use identical definitions or analysis populations.
There are five secondary outcomes posted, covering pharmacokinetic measures: area under the concentration-time curve over 24 hours, maximum concentration, time to maximum concentration, time to maximum concentration, apparent terminal elimination half-life, and concentration at 24 hours. The registry’s list names area under the concentration-time curve, maximum concentration, time to maximum concentration, apparent terminal elimination half-life, and concentration at 24 hours. Numerical results for those outcomes are not included in the record details summarized for interpretation; the record lists five secondary outcomes but reports no analyses. The total number of outcome measures is 7, but the registry record does not provide an analysis for those secondary outcomes in the posted information.
No statistical significance claim is warranted from the arm-specific percentages alone. Nor can the safety profile be characterized fully from a single broad endpoint and aggregate serious-event counts. The record supports a descriptive reading of the outcomes reported, while leaving uncertainty about statistical precision, event types, and dose-specific patterns.
9. Statistical Methods Explained
The reported primary outcome is count-based: participants are classified according to whether they had any clinical adverse experience. The registry gives a percentage for each arm and the corresponding group sizes. This is a descriptive presentation of the observed outcome. The registry record does not report a statistical test, confidence interval, or adjusted model for the primary endpoint, and it lists no analyses. Accordingly, the posted numbers do not support a formal claim that the arms differ statistically.
What do the percentages represent?
A participant-level percentage for an “any experience” outcome summarizes the share of participants with at least one event during follow-up. It differs from an event rate, which might count repeated events or incorporate time at risk. A participant with several experiences contributes once to the “any” endpoint. The measure is useful as a broad safety summary, but it does not describe the number or seriousness of events among affected participants. The endpoint is stated as a percentage of participants, and the registry reports 51.9% for MK-0941 and 61.1% for placebo.
Why does precision matter?
General statistical context: any estimate based on a sample is subject to sampling variation. A confidence interval gives an indication of the precision of an estimate and the range of values that remain compatible with the data under the method used. The registry does not report confidence intervals for these percentages. It is therefore not possible to assess their precision directly from the record. The arm sizes are 52 for MK-0941 and 18 for placebo; the smaller placebo group generally contains less information for estimating its event proportion, all else equal. That general point does not determine the exact uncertainty for these results.
What can be inferred from the missing comparison?
The registry’s posted information indicates that values are missing or not estimable for a two-arm comparison for this count-based outcome. No p-value or effect estimate for an unadjusted comparison is reported. A statistical test would address how compatible the observed data are with a specified null model, while an effect estimate and interval would describe the magnitude and precision of a difference on a chosen scale. None of those inferential quantities is available in the record. The values 51.9% and 61.1% should therefore remain descriptive results rather than be translated into a conclusion about a statistically reliable difference.
How should the pharmacokinetic outcomes be understood?
The registry lists five secondary pharmacokinetic outcomes: area under the concentration-time curve over 24 hours, maximum concentration, time to maximum concentration, apparent terminal elimination half-life, and concentration at 24 hours. In general, these summarize different features of drug concentration after dosing. Area under the curve describes exposure over a specified interval; maximum concentration is the observed peak; time to maximum concentration describes when that peak occurs; terminal half-life characterizes the decline in the terminal phase; and a 24-hour concentration describes the measured concentration at that time. These general definitions do not establish any study result. Numerical estimates, dispersion measures, and analyses for these outcomes are not reported in the registry record.
The fact record identifies 7 outcome measures overall and 0 analyses. Those counts indicate that outcomes were listed but do not supply inferential results. The record does not report whether the pharmacokinetic summaries were analyzed by dose panel, pooled across panels, or adjusted for any covariates.
What does the planning illustration mean?
General statistical context: a sample-size planning illustration asks how many participants might be needed under specified assumptions to detect a chosen effect with a target level of statistical power. The registry information describes an illustration based on the observed effect, with two-sided significance level 0.05, equal allocation between arms, and a normal approximation. It says the target effect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the original study was designed with those assumptions. The numerical planning outputs are not reported in the registry record addressed by these results. The study’s own sample-size justification is not reported in the registry record.
General statistical context: over-dispersion matters when a count outcome varies more than a simple statistical model expects. A model that ignores such extra variability can understate uncertainty and make results appear more precise than they are. The primary outcome is a participant-level indicator of any event rather than a count of repeated events, and the registry does not report a model or dispersion estimate. No claim about over-dispersion in this trial can therefore be made.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and five secondary outcomes. The primary measure concerns participants with any clinical adverse experience; the secondary outcomes describe pharmacokinetic measures after multiple doses. The record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a prespecified strategy for controlling the chance of false-positive findings across multiple tests. It also lists 0 analyses, so no multiplicity-adjusted or unadjusted test results are available in the posted information.
General statistical context: when several outcomes are tested, the chance of at least one apparently unusual result can increase if each is assessed independently at the same threshold. Researchers may address this through a prespecified hierarchy or adjustment, but the registry record does not state whether any such approach was planned or used. The absence of that information does not establish that multiplicity was ignored; the analysis plan is not reported in the registry record.
The record does not describe missing outcome data, withdrawals, exclusions, or how incomplete observations were handled. It does not identify an intention-to-treat population, a safety population, or a pharmacokinetic analysis population. The listed arm sizes are 52 for MK-0941 and 18 for placebo, but the record does not say whether those are the denominators used for every endpoint or whether any participants were excluded from particular analyses.
The registry also does not report a missing-data method, imputation approach, or sensitivity analysis. For the primary outcome, the available percentages and arm sizes allow a descriptive reading, but the handling of participants without complete follow-up is not stated. These omissions make it difficult to determine how robust the outcome summaries are to missingness or differences between the enrolled groups and the analyzed groups.
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 |
|---|---|---|---|
| MK-0941 | 0 | 52 | 0.0% |
| Placebo | 0 | 18 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MK-0941 | 27 of 52 |
| Placebo | 11 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MK-0941 | Placebo |
|---|---|---|---|
| Headache | Nervous system disorders | 11 of 52 | 5 of 18 |
| Hypoglycaemia | Metabolism and nutrition disorders | 10 of 52 | 0 of 18 |
| Dizziness | Nervous system disorders | 5 of 52 | 1 of 18 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 3 of 52 | 1 of 18 |
| Anaemia | Blood and lymphatic system disorders | 3 of 52 | 0 of 18 |
| Diarrhoea | Gastrointestinal disorders | 2 of 52 | 1 of 18 |
| Eye pruritus | Eye disorders | 1 of 52 | 1 of 18 |
| Abdominal pain | Gastrointestinal disorders | 0 of 52 | 2 of 18 |
| Pruritus | Skin and subcutaneous tissue disorders | 1 of 52 | 1 of 18 |
| Eye pain | Eye disorders | 0 of 52 | 1 of 18 |
The registry reports zero serious adverse experiences among 52 participants in the MK-0941 group and zero among 18 participants in the placebo group. These are the posted serious-event counts for the two groups. The record does not list any top serious-event terms. The death counts are not reported in the registry record.
Zero recorded serious events in a study group does not establish that the underlying risk is zero. General statistical context: when an event is uncommon, a study may observe no instances even though the event could occur in a larger population or with longer follow-up. The information in this record does not provide an interval estimate for the serious-event frequency or a formal comparison between arms.
The registry separately reports 27 participants with other adverse experiences in the MK-0941 group and 11 in the placebo group. Serious and other adverse experiences are distinct categories in the adverse-event listing, and the primary endpoint is described as participants with any clinical adverse experience. The record does not provide enough detail to reconcile the category definitions or determine whether all entries use the same analysis population. The serious-event counts should therefore be read narrowly: they describe the serious events recorded in the posted groups, not the entirety of safety experience or a guarantee about risks beyond the study’s follow-up.
12. What the Result Does, and Does Not, Mean
The results establish a descriptive record of a randomized Phase 1 study of multiple-dose MK-0941 in participants with type 2 diabetes. The primary outcome is any clinical adverse experience, assessed approximately 30 days after the last dose, except that the stated follow-up is 14 days for participants receiving MK0941 40 mg before each meal. The registry reports 51.9% in the MK-0941 group and 61.1% in the placebo group. It also reports zero serious adverse experiences in each arm.
These results do not establish that MK-0941 reduces adverse experiences, nor do they establish that the groups have equivalent safety. The registry does not report an inferential comparison, confidence intervals, or an adjusted analysis for the primary endpoint. Without those details, the observed percentages cannot show whether the difference is precise, statistically distinguishable from chance variation, or clinically important. No medical conclusion should be drawn from the percentages alone.
The study’s stated aims also included pharmacokinetics and pharmacodynamics. Five secondary pharmacokinetic outcomes are listed, but numerical analyses for them are not reported in the registry record addressed by these results. The record therefore does not permit conclusions about drug exposure, peak concentration, timing, elimination, or the concentration measured at 24 hours. Pharmacodynamic results are not reported in the registry record.
The findings are limited to the enrolled study groups and the specified observation period. The registry does not provide longer-term follow-up, dose-specific outcome summaries, or enough detail about missing data and analysis populations to determine how broadly the results apply. The record describes the study as intended to inform continued clinical investigation; it does not establish the result of later research or answer questions about clinical benefit.
In short, the posted data are descriptive safety observations from a small early-phase study, with no reported formal two-arm analysis for the primary endpoint. They should be interpreted as a record of what was observed in these groups during the stated follow-up, not as proof of absence of risk, a confirmed difference, or a treatment effect.
13. Why This Trial Matters Statistically
This trial illustrates why the statistical meaning of a result depends on more than the point estimate. The registry reports the proportion of participants with any clinical adverse experience in each arm, but it does not provide a confidence interval or a statistical comparison. The percentages describe what was recorded; they do not, by themselves, indicate how precisely the underlying event proportions have been estimated or whether the groups differ beyond sampling variability.
The arm sizes are unequal, with 52 participants in the MK-0941 group and 18 in the placebo group. That imbalance is relevant to precision, particularly for the smaller group, and reinforces the value of intervals and clearly specified analyses. Because neither is reported for the primary outcome, readers should resist treating the numerical separation between the percentages as a settled result.
The trial also demonstrates the distinction between a broad safety endpoint and detailed event characterization. Counting participants with any experience is straightforward to interpret, but it compresses events of potentially different types and severities into one measure. The serious-event listing supplies an additional view, reporting zero in each group, while leaving event-specific descriptions and death counts unavailable in the registry record.
Finally, the study’s early-phase objectives combine tolerability with pharmacokinetic assessment. The five listed secondary outcomes describe concentration-related measures, yet the registry record does not provide their analyses. This gap separates the study’s stated aims from the evidence a reader can evaluate from the posted results. The trial is therefore a useful example of how registry transparency, analysis detail, and uncertainty estimates shape the interpretation of clinical research.
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.
Important trial-specific details are not reported in the registry record. The arm descriptions are blank, so the dose composition of the MK-0941 group and the allocation across sequential panels cannot be reconstructed. Although the official title describes dosing before each meal and the primary-outcome timeframe refers to MK0941 40 mg before each meal, the record does not state how many participants received that dose or how results vary by dose.
The primary result is reported as a percentage for each group, without a confidence interval, p-value, effect estimate, or adjusted comparison. The registry indicates that a two-arm comparison was missing or not estimable for this count-based endpoint. The posted results therefore support description but not a formal conclusion about the between-group difference. The record also does not report the statistical analysis plan or the study’s sample-size justification.
Analysis populations and participant flow are not described. The record does not state whether all enrolled participants contributed to the primary endpoint, how incomplete follow-up was handled, or whether participants were excluded from pharmacokinetic analyses. It does not report withdrawal counts or reasons. This prevents assessment of the influence of missing data or the correspondence between enrollment and endpoint denominators.
Although five secondary outcomes are listed, their numerical analyses are not reported in the registry record. Pharmacodynamic results are also not reported. The record does not provide multiplicity procedures, outcome-specific analysis methods, or details of adjustments for covariates. Serious adverse experiences are reported as zero in both groups, but death counts are not reported in the registry record, and event-specific descriptions are unavailable. The stated follow-up is limited to approximately 30 days after the last dose, with 14 days for the specified 40 mg regimen; longer-term outcomes are not reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005) — NCT00511667.
- Registry record last updated 2016-08-24; status last verified 2016-08.
- Results first posted 2012-06-26.
- 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 completed Phase 1 study evaluated multiple-dose MK-0941 in participants with type 2 diabetes using randomized allocation, double masking, a parallel-group model, and placebo comparison. The registry reports enrollment of 70, with 52 participants in the MK-0941 arm and 18 in the placebo arm. The study started in 2007-05 and reached primary completion in 2008-04.
The primary outcome was participants with any clinical adverse experience. The registry reports 51.9% for MK-0941 and 61.1% for placebo, with no inferential comparison reported. Serious adverse experiences were recorded for zero participants in each group. Five secondary pharmacokinetic outcomes are listed, but their analyses are not reported in the registry record.
The stated purpose was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics after multiple daily administration. The posted information supports a descriptive account of the primary safety outcome and serious-event counts. Dose-specific results, analysis populations, missing-data handling, and the statistical plan are not reported in the registry record.