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 Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (NCT03371108), a randomized phase 3 study. The primary outcome is Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03371108 |
| Phase | Phase 3 |
| Condition | Diabetes Mellitus, Type 2 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 567 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Gan and Lee Pharmaceuticals, USA |
| Results posted | Yes |
2. Clinical Question
Population
Adults with type 2 diabetes mellitus. The primary endpoint used the Safety Analysis Set: randomly assigned participants who received any study treatment, including a partial dose, and had non-missing values.
Intervention
Gan & Lee Insulin Glargine Injection, a 100 U/mL solution for subcutaneous injection in a prefilled Gan & Lee injector pen. Participants were assigned to take part for 26 weeks.
Comparator
Lantus®, a 100 U/mL solution for subcutaneous injection in a prefilled SoloStar® insulin pen. Participants were assigned to take part for 26 weeks.
Primary question
Did the groups meet the study’s objective of equivalence in treatment-induced anti-insulin antibody response from baseline to Week 26? The endpoint counted a newly confirmed positive antibody status among participants negative at baseline, or a 4-fold increase in titer among participants positive at baseline.
The registry describes a phase 3, randomized, multicenter, open-label, parallel-group study. Its primary objective was to evaluate equivalence between the two insulin glargine products in immunogenicity. The endpoint captures whether participants met a defined antibody-response criterion during follow-up; it is not a general measure of all immune responses or of clinical efficacy.
The primary result is reported as a risk difference with a 90% confidence interval. That interval describes the precision of the estimated between-group difference. Equivalence requires interpreting the interval against prespecified equivalence limits. Those limits are not reported in the registry record, so the numerical result can be described, but the record alone does not show the criterion used to conclude equivalence.
3. Trial Design
The registry describes a phase 3, randomized, multicenter, open-label study with a parallel-group design. It enrolled 567 participants with type 2 diabetes mellitus and is listed as completed. The recorded study start was 2017-10-31, and primary completion was 2019-04-17. Participants were assigned to Gan & Lee Insulin Glargine Injection or Lantus® and took part for 26 weeks.
Both interventions were insulin glargine solutions for subcutaneous injection at 100 U/mL. The Gan & Lee product was posted in an integrated, disposable, prefilled injector pen, while Lantus® was posted in a SoloStar® prefilled pen. The study was open-label, meaning masking was not used according to the registry record. The record does not describe additional steps to conceal treatment assignment from participants or study personnel.
The primary endpoint analysis included 281 participants in the Gan & Lee group and 282 in the Lantus® group. The registry defines the Safety Analysis Set as participants whose treatment assignment was randomized, who received any study treatment—even a partial dose—and had non-missing values. Other analysis populations, including an intention-to-treat population, are not reported in the registry record.
The primary objective concerned equivalence in immunogenicity, with treatment-induced anti-insulin antibody response assessed from baseline to Week 26. Secondary objectives covered additional antibody measures, safety, and efficacy. The registry lists change from baseline in HbA1c and measures of antibody response and glycemic control among the secondary outcomes. The detailed protocol, allocation procedures, sample-size justification, and statistical analysis plan are not reported in the registry record. The enrollment figure is a study-level figure; it should not be treated as the analysis denominator for every outcome, since outcome-specific denominators differ.
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: Inclusion and Exclusion Criteria.
Safety Analysis Set
| Stage | Gan & Lee Insulin Glargine Injection | Lantus® |
|---|---|---|
| STARTED | 284 | 283 |
| COMPLETED | 281 | 282 |
| NOT COMPLETED | 3 | 1 |
Completers
| Stage | Gan & Lee Insulin Glargine Injection | Lantus® |
|---|---|---|
| STARTED | 281 | 282 |
| COMPLETED | 259 | 256 |
| NOT COMPLETED | 22 | 26 |
Analysis population for the primary outcome, as defined in the registry: The Safety Analysis Set (SS) was comprised of all subjects whose treatment assignment was randomly assigned who received any of the study treatment, even a partial dose, and had non-missing values.
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: All Subjects Assigned randomly to treatment (full analysis set).
| Characteristic | Unit | Gan & Lee Insulin Glargine Injection | Lantus® | Total |
|---|---|---|---|---|
| Participants analysed | 284 | 283 | 567 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 163 | 178 | 341 |
| Age, Categorical: >=65 years | Participants | 121 | 105 | 226 |
| Sex: Female, Male: Female | Participants | 104 | 122 | 226 |
| Sex: Female, Male: Male | Participants | 180 | 161 | 341 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 59 | 69 | 128 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 223 | 213 | 436 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Asian | Participants | 15 | 12 | 27 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Black or African American | Participants | 35 | 36 | 71 |
| Race (NIH/OMB): White | Participants | 227 | 225 | 452 |
| Race (NIH/OMB): More than one race | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 5 | 6 |
| Region of Enrollment: United States | Participants | 284 | 283 | 567 |
| AIA result: Negative | Participants | 252 | 263 | 515 |
| AIA result: Positive | Participants | 5 | 1 | 6 |
| AIA result: Nonreportable | Participants | 27 | 19 | 46 |
| Body Mass Index (BMI) ≤45 kg/m^2 | kg/m2 | 33.49 (SD 5.589) | 33.59 (SD 6.025) | 33.54 (SD 5.806) |
| Duration of Diabetes (Years) | Years | 15.2 (SD 7.96) | 15.3 (SD 7.92) | 15.3 (SD 7.93) |
| HbA1c (%) | HbA1c (%) | 8.49 (SD 1.027) | 8.51 (SD 1.029) | 8.50 (SD 1.027) |
| NAb result: Negative | Participants | 5 | 1 | 6 |
| NAb result: Positive | Participants | 0 | 0 | 0 |
| NAb result: Not Tested | Participants | 279 | 282 | 561 |
| Thyroid Disease: Absence | Participants | 243 | 229 | 472 |
| Thyroid Disease: Presence | Participants | 41 | 54 | 95 |
| Thyroid Disease: Hypothyroidism | Participants | 34 | 45 | 79 |
| Thyroid Disease: Hyperthyroidism | Participants | 2 | 0 | 2 |
| Thyroid Disease: Structural abnormality | Participants | 1 | 1 | 2 |
| Thyroid Disease: Thyroid Cancer | Participants | 0 | 0 | 0 |
| Thyroid Disease: Other | Participants | 4 | 8 | 12 |
| Weight (kg) | Weight (kg) | 98.011 (SD 20.0532) | 98.141 (SD 20.5269) | 98.076 (SD 20.2732) |
6. Primary Endpoint
The registry lists the primary outcome as Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint, measured over Baseline to Week 26.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of subjects with TI-AIA |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the percentage of participants classified as experiencing treatment-induced anti-insulin antibody response, or TI-AIA, between baseline and Week 26. A participant met the definition if their antibody status became newly confirmed positive after a negative baseline result, or if their titer increased by at least a 4-fold amount after a positive baseline result. The registry describes the endpoint as a participant-level classification, summarized as the percentage in each group.
This endpoint was selected to address the study’s primary immunogenicity objective: comparing antibody responses to the two products. Combining new confirmed positivity and a substantial titer increase permits the endpoint to include participants with different baseline antibody status. The definition is specific to this study; it does not by itself represent every possible antibody response or establish the clinical importance of an observed response.
The registry reports 54 participants in the Gan & Lee group and 60 in the Lantus® group as experiencing TI-AIA, with analysis denominators of 281 and 282, respectively. The primary comparison is a reported risk difference with a 90% confidence interval. The endpoint’s timeframe is baseline to Week 26. Further details about missing antibody measurements, confirmation procedures, and the statistical handling of the percentage are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a risk difference of -2.1 for the primary comparison, with a 90% confidence interval from -7.6 to 3.5. The reported analysis is labeled as an equivalence analysis. The point estimate is the reported between-group difference; the confidence interval describes the range of values compatible with the data under the analysis. Because the registry does not report the prespecified equivalence limits, the interval alone cannot establish whether the formal equivalence criterion was met.
The primary endpoint counts were 54 of 281 participants in the Gan & Lee group and 60 of 282 in the Lantus® group. These are counts of participants meeting the endpoint definition, not continuous measurements of antibody titer. The reported analysis does not include a p-value. A p-value is not necessary to describe the estimate and confidence interval, and its absence should not be replaced by an invented significance conclusion.
Equivalence is a distinct statistical question from whether a conventional test detects a difference. In an equivalence framework, the study asks whether the plausible between-group differences are sufficiently close to zero according to limits chosen before interpreting the data. A confidence interval that includes zero does not by itself demonstrate equivalence; the interval must also be compared with those limits. Since the limits are not reported in the registry record, the registry’s equivalence label can be reported, but its decision rule cannot be independently checked from the posted information.
The secondary results cover different outcomes and analysis denominators. For example, the HbA1c result is a least-squares mean change, while the antibody outcomes are participant counts. These estimates do not answer precisely the same question as the primary endpoint. They should be understood as additional outcome-specific evidence, rather than as substitutes for the primary equivalence comparison.
The record also reports adverse-event counts, including serious adverse events and other adverse events, as well as zero deaths in each group. These are descriptive counts. The registry information does not establish whether any event was caused by treatment, and the counts alone do not provide a complete account of the timing, severity, or clinical context of events. No conclusion about treatment benefit or lack of benefit follows from the statistical estimates alone.
9. Statistical Methods Explained
The primary outcome is binary at the participant level: each participant either met the TI-AIA definition during baseline to Week 26 or did not. The registry reports the number meeting the definition in each treatment group and a risk difference for the comparison. A risk difference expresses the difference between the groups’ event proportions on an absolute scale. The posted analysis gives a value of -2.1 and a 90% confidence interval from -7.6 to 3.5. The registry does not state the calculation details or the orientation convention for the difference, so interpretation should stay with the reported estimate and comparison.
What does a confidence interval convey?
General statistical explanation: a confidence interval represents uncertainty around an estimate under the method used to calculate it. A narrower interval generally indicates greater precision, while a wider interval indicates that a broader range of values remains compatible with the data. It is not a guarantee that the true value lies inside the particular interval, and it does not communicate the probability that a treatment is effective. The primary interval is reported at 90% confidence. The registry does not provide the underlying analysis method or further assumptions needed to reproduce it.
How does equivalence differ from testing for a difference?
General statistical explanation: a conventional test for a difference asks whether the data are inconsistent with a specified no-difference value. Equivalence instead asks whether the difference is sufficiently small to lie within prespecified boundaries on both sides of that value. A result may fail to show a statistically detectable difference without demonstrating equivalence. The relevant boundaries, sometimes called equivalence margins, need to be defined in advance and assessed against the confidence interval. The registry labels the primary analysis as equivalence but does not report those boundaries or the decision procedure. Therefore, the reported estimate can be interpreted descriptively, while the formal equivalence determination cannot be independently reconstructed from the registry record.
What do the secondary estimates represent?
One secondary outcome is change from baseline in HbA1c to Week 26, reported as a least-squares mean for each group with a standard error. A least-squares mean is an estimate from a statistical model, rather than simply a raw average; the model details are not reported in the registry record. The posted contrast is -0.06, with a confidence interval from -0.279 to 0.159 and an unadjusted p-value of 0.591. The record does not explain the model covariates or any adjustments used to produce the least-squares means.
Other posted secondary outcomes are counts of participants meeting antibody-related definitions. Their denominators are outcome-specific, so they need not match the primary endpoint denominators. Some groups are small, particularly for the outcome involving neutralizing antibodies. General statistical explanation: when event counts are limited, an estimate can be imprecise, and confidence intervals may span a broad range of possible effects. The recalculated risk differences and their intervals are unadjusted comparisons from the posted summary counts; they do not incorporate covariate adjustment unless explicitly stated, and the registry does not report an adjusted analysis for these outcomes.
How should the planning illustrations be read?
The sample-size illustrations use the observed effect as a planning reference and show hypothetical participants per arm for specified power targets and fractions of that observed effect. They are not observed power, do not describe the trial’s original sample-size justification, and do not establish what sample size the trial should have used. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation. General statistical explanation: planning calculations are sensitive to the assumed effect, variability, outcome frequency, and analysis method. When the effect used for planning is estimated from the same trial, uncertainty in that estimate is not removed simply by expressing the result as a sample-size target. The trial’s own design assumptions and justification are not reported in the registry record.
For outcomes with over-dispersion, a model that assumes less variability than is present can produce uncertainty estimates that are too small. General statistical explanation: over-dispersion means that observed variation exceeds what a particular model’s assumptions allow. The registry does not report an over-dispersion assessment or identify a count model for the primary endpoint, so this is a general consideration rather than a claim about the analysis used in this study.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Risk Difference (RD) -2.1 | -7.6 to 3.5 | not reported |
The registry’s sponsor-reported primary analysis is labeled as an equivalence analysis and gives a risk difference of -2.1, with a 90% confidence interval from -7.6 to 3.5. The registry does not report a p-value, the statistical method, or the equivalence limits used in that analysis. Without those limits, readers cannot independently confirm from the registry record how the sponsor applied the formal equivalence criterion.
No discrepancy is flagged between the sponsor-reported result and the recalculation status in the record. In any case, a recalculation from posted summary counts would be a simple, unadjusted comparison; it would not replace a sponsor’s prespecified analysis, which takes precedence if a discrepancy is identified. The posted primary comparison is the sponsor’s reported result, not a recalculated alternative.
The distinction matters because the primary endpoint is a participant count summarized as a percentage, and a formal equivalence analysis can depend on choices about the comparison method, analysis population, and decision boundaries. Those details are not reported in the registry record. Accordingly, the estimate and confidence interval can be quoted as posted, but the reported equivalence label cannot be independently evaluated against an unreported margin or analysis plan.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes in addition to the primary endpoint. It does not report a multiplicity strategy, such as a hierarchy of testing, an adjustment across comparisons, or a division between confirmatory and exploratory analyses. General statistical explanation: testing many hypotheses can increase the chance that at least one result appears notable by chance. Prespecifying how outcomes are tested helps readers understand the intended strength of evidence. In the absence of a reported strategy, individual secondary p-values should not be treated as if they necessarily control the overall chance of a false-positive conclusion.
The record also does not report the handling of missing outcome data, including whether values were imputed, how incomplete follow-up was addressed, or what assumptions were used for participants without a Week 26 measure. The primary Safety Analysis Set is defined as randomly assigned participants who received any study treatment and had non-missing values. This definition identifies who was included in that set, but it does not explain how missingness was assessed or handled for each endpoint. The analysis denominators differ across outcomes, and the reasons for those differences are not reported in the registry record.
The registry does not describe an intention-to-treat analysis population or a per-protocol population. It also does not report whether analyses were adjusted for baseline characteristics, site, or other variables, aside from identifying the HbA1c estimates as least-squares means. The model specification for those estimates is not reported. Details of randomization generation, allocation concealment, interim analyses, and the original sample-size justification are likewise not reported in the registry record.
These omissions limit independent assessment of the prespecified analysis and the robustness of the results. They do not demonstrate that any particular procedure was absent from the full study protocol; they mean only that the registry record does not describe it. The posted estimates and counts remain interpretable as recorded, but conclusions about missing-data assumptions, multiplicity control, and consistency across analysis populations cannot be checked from this information.
12. 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 |
|---|---|---|---|
| Gan & Lee Insulin Glargine Injection | 15 | 281 | 5.3% |
| Lantus® | 16 | 282 | 5.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Gan & Lee Insulin Glargine Injection | 0 of 281 |
| Lantus® | 0 of 282 |
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 |
|---|---|
| Gan & Lee Insulin Glargine Injection | 125 of 281 |
| Lantus® | 122 of 282 |
Most frequent serious adverse event terms
| Event term | Organ system | Gan & Lee Insulin Glargine Injection | Lantus® |
|---|---|---|---|
| Osteomyelitis | Infections and infestations | 2 of 281 | 1 of 282 |
| Chest Pain | General disorders | 2 of 281 | 0 of 282 |
| Skin ulcer | Skin and subcutaneous tissue disorders | 2 of 281 | 0 of 282 |
| Syncope | Nervous system disorders | 2 of 281 | 0 of 282 |
| Non-cardiac chest pain | General disorders | 1 of 281 | 1 of 282 |
| Angina pectoris | General disorders | 0 of 281 | 1 of 282 |
| Angina unstable | General disorders | 1 of 281 | 0 of 282 |
| Arthritis | Musculoskeletal and connective tissue disorders | 1 of 281 | 0 of 282 |
| B-cell small lymphocytic lymphoma | Blood and lymphatic system disorders | 0 of 281 | 1 of 282 |
| Back pain | General disorders | 1 of 281 | 0 of 282 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Gan & Lee Insulin Glargine Injection | Lantus® |
|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | 120 of 281 | 117 of 282 |
| Headache | Nervous system disorders | 2 of 281 | 1 of 282 |
| Weight Increased | Investigations | 0 of 281 | 3 of 282 |
| Dizziness | Nervous system disorders | 1 of 281 | 0 of 282 |
| Fatigue | General disorders | 0 of 281 | 1 of 282 |
| Gastroenteritis | Nervous system disorders | 0 of 281 | 1 of 282 |
| Hunger | General disorders | 0 of 281 | 1 of 282 |
| Injection related | General disorders | 1 of 281 | 0 of 282 |
| Other | General disorders | 1 of 281 | 0 of 282 |
Serious events with the highest arm-level rate: chest pain (0.7%), osteomyelitis (0.7%), skin ulcer (0.7%), syncope (0.7%), non-cardiac chest pain (0.4%).
The registry reports serious adverse events affecting 15 of 281 participants in the Gan & Lee group and 16 of 282 in the Lantus® group. Other adverse events affected 125 of 281 and 122 of 282 participants, respectively. The recorded death count is 0 in each group. These are descriptive event counts over the study period; they do not by themselves show whether an event was caused by the assigned product.
The registry’s listed serious adverse-event terms include chest pain, osteomyelitis, skin ulcer, and syncope, each reported as 0.7%, as well as non-cardiac chest pain and unstable angina, each reported as 0.4%. The record does not provide a group-specific breakdown for these terms in the information posted. The percentages should therefore not be interpreted as comparative rates between groups.
Comparing raw safety counts does not account for event timing, duration, severity, participant characteristics, or exposure. The registry record does not provide a detailed causal assessment or the full context needed to interpret each event. The counts are useful for describing what was recorded, but they are not, on their own, proof of a safety difference or of the absence of one.
13. What the Result Does, and Does Not, Mean
The primary result is a reported between-group risk difference of -2.1, with a 90% confidence interval from -7.6 to 3.5, for the study’s TI-AIA endpoint from baseline to Week 26. The registry labels the analysis as an equivalence analysis. The estimate and interval summarize the posted comparison, while the endpoint counts show how many participants met the study’s antibody-response definition in each analysis group.
What the result does not show from the registry record alone is whether the formal equivalence criterion was satisfied. That judgment depends on prespecified equivalence limits, which are not reported. An interval that includes zero is not, by itself, evidence of equivalence. The registry’s analysis label can be conveyed, but the reader cannot assess the decision boundary or independently reconstruct the sponsor’s decision from the posted information.
The primary endpoint is an immunogenicity measure, not a complete measure of efficacy, safety, or overall clinical outcome. Secondary outcomes add information about HbA1c and other antibody or glycemic measures, but those outcomes have different definitions and denominators. The registry does not report results for every listed secondary outcome, and it does not describe a multiplicity strategy. They therefore should not be treated as a substitute for the primary analysis or as a collection of independent confirmatory conclusions.
Safety counts describe events recorded during the study, but they do not establish causation. Likewise, a difference that is small or imprecise in a particular estimate should not be turned into a claim that the treatments are identical. General statistical explanation: estimates describe the observed data through a specified analysis, and uncertainty intervals indicate how much precision that analysis provides. Neither alone determines clinical importance.
The most defensible reading is limited to the registry’s reported endpoint definition, participant counts, estimate, interval, and study design. Details needed to evaluate equivalence margins, missing-data assumptions, multiplicity, and analysis populations beyond the defined Safety Analysis Set are not reported in the registry record.
14. Why This Trial Matters Statistically
This trial raises a useful statistical distinction: demonstrating equivalence is not the same as failing to detect a difference. The registry explicitly identifies the primary comparison as an equivalence analysis and reports a risk difference with a 90% confidence interval. That makes the equivalence limits especially important. Because the limits are not reported in the registry record, the numerical result can be examined but the formal criterion cannot be independently checked.
The endpoint also illustrates how a composite classification can combine different participant pathways. Participants negative at baseline could meet the endpoint through newly confirmed positivity; participants positive at baseline could meet it through a 4-fold titer increase. Such a definition can capture antibody changes across baseline groups, but readers need the precise rule and the analysis denominator to interpret what the count represents. The registry provides the definition and Safety Analysis Set description, while some operational details are not reported.
For biostatisticians and clinical researchers, the record is also a reminder that registry outcomes and posted analyses may not fully specify the statistical plan. Secondary outcomes span binary counts and a modeled continuous measure, with different denominators and precision. Without a reported multiplicity approach, missing-data strategy, and model specification, it is difficult to assess how the findings fit together as a confirmatory evidence package.
The trial’s randomized parallel-group design supports a structured comparison, but design labels alone do not provide all information needed to appraise the analysis. Reporting the equivalence margins, analysis assumptions, and handling of incomplete observations would make the primary result more independently interpretable. The posted data remain useful, provided their scope and the limits of what the registry describes are kept clear.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific details needed to reproduce or fully evaluate the primary equivalence analysis are not reported in the registry record. These include the equivalence margins, the statistical method used for the risk difference, and the decision rule applied to the 90% confidence interval. The record also does not provide a p-value for the primary comparison. Consequently, the reported estimate can be described, but the formal equivalence conclusion cannot be independently reconstructed from the registry information.
The primary analysis population is defined as participants randomly assigned, exposed to any amount of study treatment, and with non-missing values. The registry does not report an intention-to-treat analysis, a per-protocol analysis, or sensitivity analyses using alternative populations. It also does not describe how missing endpoint values were handled or whether missingness patterns differed between groups. These gaps matter because the endpoint’s denominator is based on available non-missing values.
The record does not report the original sample-size justification or design assumptions. The planning illustrations based on observed effects are not evidence of the trial’s original power or design adequacy. It is also not possible to determine from the registry whether interim analyses were planned or conducted. Randomization generation and allocation concealment details are not reported, and the study was open-label.
Secondary findings have further constraints: several outcomes have distinct and sometimes small denominators, model details for the least-squares mean outcome are not reported, and no multiplicity strategy is described. Results for some listed secondary outcomes are not reported in the registry record. Safety event terms are not broken down by group in the posted listing, and the registry does not provide a causal assessment for the events. These are limitations of the registry information and do not establish what was or was not included in the full protocol or study report.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Gan & Lee Insulin Glargine Target Type (2) Evaluating Research — NCT03371108.
- Registry record last updated 2022-04-01; status last verified 2021-12.
- Results first posted 2022-03-23.
- 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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19. Record Summary
The registry describes a completed phase 3, randomized, multicenter, open-label, parallel-group study of Gan & Lee Insulin Glargine Injection versus Lantus® in adults with type 2 diabetes mellitus. Enrollment was 567, and participants were assigned to 26 weeks of treatment.
The primary endpoint was TI-AIA from baseline to Week 26, defined by newly confirmed antibody positivity or a 4-fold titer increase, depending on baseline antibody status. The posted primary comparison was labeled as an equivalence analysis and reported a risk difference of -2.1 with a 90% confidence interval from -7.6 to 3.5. The equivalence limits and analysis method are not reported in the registry record.
The record includes secondary outcome information and descriptive safety counts, but not results for every listed secondary outcome. It does not report the multiplicity strategy, missing-data methods, original sample-size justification, or full statistical analysis plan. These omissions limit independent evaluation of the prespecified analysis and the basis for the equivalence conclusion.