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 REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) (NCT01483560), a randomized phase 3 study. The primary outcome is Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01483560 |
| Phase | Phase 3 |
| Condition | Diabetes Mellitus, Type 1 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 493 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Glasgow |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 40 years and over with confirmed type 1 diabetes and increased cardiovascular disease risk. The registry record reports enrollment of 493 participants and describes recruitment in the United Kingdom, Australia, Canada, Denmark and the Netherlands.
Intervention
Metformin added to titrated insulin therapy. The metformin description specifies oral treatment, initially 500mg, titrated toward 2000mg daily. Insulin was titrated toward a target HbA1c of 7.0%/53 mmol/mol.
Comparator
Placebo alongside titrated insulin therapy. The registry record lists a placebo intervention, but does not describe its formulation or the titration details for the placebo group.
Primary question
Whether adding metformin to insulin therapy reduces progression of averaged mean far wall common carotid artery intima-media thickness, measured over the trial's stated follow-up. The registry record does not report a numerical primary outcome comparison or its uncertainty.
In plain language, the trial asks whether the addition of metformin is associated with a different pattern of change in a measure of carotid artery wall thickness than placebo, among adults with type 1 diabetes selected for increased cardiovascular risk. The primary endpoint is a continuous measurement in millimetres, taken at baseline and at follow-up visits. Its purpose in the trial is to represent progression of atherosclerosis; it is not itself a count of cardiovascular events.
The question concerns an add-on treatment strategy, not metformin replacing insulin. The brief summary describes both groups as receiving titrated insulin therapy, while the randomized contrast is metformin versus placebo. The registry record also lists secondary outcomes including HbA1c, LDL cholesterol, estimated glomerular filtration rate, weight, insulin dose, endothelial function, and retinopathy progression. Those outcomes broaden the set of clinical measures considered, but the record does not report their results or the analyses used to assess them.
3. Trial Design
REMOVAL is identified in the registry as a phase 3, randomized, triple-masked, parallel-group study. The sponsor is the University of Glasgow, and the status is completed. The record lists enrollment of 493 participants. It gives a start date of 2011-12 and a primary completion date of 2017-03-19. The trial is described as taking place in the United Kingdom, Australia, Canada, Denmark and the Netherlands.
Participants were assigned to a metformin or placebo group. The metformin arm is described as oral metformin, beginning at 500mg and titrated to a target of 2000mg daily. The brief summary frames the intervention as metformin added to titrated insulin, with insulin directed toward target HbA1c 7.0%/53 mmol/mol. The placebo arm is named, but its arm description is blank in the registry record. The record does not specify the operational details of masking, the allocation procedure, or the placebo formulation.
The trial's stated aim was to test the effect of 3 years of treatment on atherosclerosis, assessed using progression of carotid intima-media thickness. The primary outcome description specifies averaged mean far wall common carotid artery intima-media thickness measured by B mode ultrasonography. It lists measurements at baseline and at 12, 24 and 36 months, with imaging at anterior, lateral and posterior angles and use of Meijer's arc to standardize the transducer angle.
A randomized parallel design is intended to compare outcomes between groups assigned to different interventions over the same study period. Masking is intended to limit the influence of treatment knowledge on aspects of trial conduct and assessment, but the precise masking procedures are not reported in the registry record. The record does not report how randomization was generated or concealed, how adherence was assessed, or how departures from assigned treatment were handled. Those details should not be inferred from the design labels alone.
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: 493 participants where enrolled and consented. All participants entered a 3 month Run In phase with placebo. Participants who remained eligible were randomly assigned to receive metformin or placebo for 3 years. 65 participants where ineligible to be randomized.
Overall Study
| Stage | Metformin | Placebo |
|---|---|---|
| STARTED | 219 | 209 |
| COMPLETED | 193 | 194 |
| NOT COMPLETED | 26 | 15 |
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 | Metformin | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 219 | 209 | 428 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 219 | 209 | 428 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 55.2 (SD 8.5) | 55.8 (SD 8.8) | 55.5 (SD 8.7) |
| Sex: Female, Male: Female | Participants | 90 | 85 | 175 |
| Sex: Female, Male: Male | Participants | 129 | 124 | 253 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Canada | participants | 55 | 55 | 110 |
| Region of Enrollment: Netherlands | participants | 16 | 15 | 31 |
| Region of Enrollment: Denmark | participants | 4 | 4 | 8 |
| Region of Enrollment: United Kingdom | participants | 112 | 105 | 217 |
| Region of Enrollment: Australia | participants | 32 | 30 | 62 |
| Diabetes Diagnosis Duration | years | 33.4 (SD 11) | 34.3 (SD 10.5) | 33.85 (SD 10.75) |
| Existing Cardiovascular Disease | participants | 30 | 22 | 52 |
| Baseline HbA1c | mmol/mol | 64.8 | 64.7 | 64.75 |
| Daily Insulin Dose | units/kg | 0.63 | 0.68 | 0.66 |
| BMI | kg/m2 | 28.4 (SD 4.5) | 28.5 (SD 4.1) | 28.5 (SD 4.3) |
| Blood Pressure | Systolic BP (mmHg) | 130.5 (SD 15) | 128.5 (SD 14.6) | 129.5 (SD 14.8) |
| Total Cholesterol | mmol/L | 4 (SD 0.88) | 4 (SD 0.93) | 4 (SD 0.91) |
| eGFR | ml/min/1.73m2 | 92.9 (SD 20.9) | 91.1 (SD 21.6) | 92 (SD 21.3) |
| Diabetic Retinopathy | participants | 51 | 58 | 109 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT), measured over 0, 12 months, 24 months, 36 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in averaged mean far wall common carotid artery intima-media thickness, abbreviated cIMT in the registry description. It is a continuous measurement reported in millimetres. The stated measurement method is B mode ultrasonography using a 7.0 MHz or higher broadband linear array transducer, with concurrent recording of a 3-lead electrocardiogram. Longitudinal images are described at baseline and at 12, 24 and 36 months, with views taken at anterior, lateral and posterior angles. Meijer's arc is used to standardize the transducer angle.
The endpoint is intended to represent progression of atherosclerosis. As a continuous measure, cIMT can capture gradations in wall thickness rather than reducing the outcome to whether a participant did or did not experience an event. Repeated assessment can describe how the measure changes over follow-up. These are general properties of continuous longitudinal outcomes; they do not establish that a difference in cIMT necessarily corresponds to a particular difference in clinical events.
The registry record identifies the endpoint and its measurement schedule but does not report the numerical results, the definition used to calculate change, or a treatment-effect estimate. It also does not report the statistical model used to compare groups across visits. Consequently, the endpoint's clinical interpretation cannot be based on a numerical group contrast from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the trial's primary question and outcome, but it does not report a primary outcome estimate, confidence interval, p-value, or numerical comparison between metformin and placebo. The record therefore does not establish, from the posted results, the direction or magnitude of a difference in cIMT. No conclusion about the size or precision of a primary treatment contrast can be drawn from the registry information presented.
This distinction matters because a trial's stated aim is not a result. The description of a randomized comparison tells readers what was intended to be studied; it does not indicate what the measured outcomes were. Likewise, enrollment of 493 participants describes the trial's overall enrollment, not the number contributing data to the primary endpoint at each visit. The numbers analyzed for the primary outcome are not reported in the registry record.
When a numerical estimate is available, its interpretation should consider both its magnitude and its uncertainty. In general, a confidence interval describes a range of values compatible with the data under the assumptions of the analysis. A narrow interval is more precise than a wide interval, while an interval spanning effects in different directions may leave the direction uncertain. These general principles cannot be applied to REMOVAL's primary comparison from this registry record because no estimate or interval is reported.
The record does list safety counts for serious and other events, but those are separate from the cIMT endpoint. They should not be used as a substitute for the primary efficacy estimate, nor do the event counts alone show whether observed events were caused by the assigned treatment. The registry record also lists secondary outcome topics without numerical results. There is therefore no basis in this record for describing whether those measures differed between groups.
The status is completed, but completion does not mean that all outcome results are included in the registry record. The listed primary completion date indicates the recorded timing of primary completion; it does not supply the missing estimate or the analytical details. Readers should distinguish carefully between trial design, outcome definitions, and reported findings. Here, design and outcome details are available, while the primary comparison and the supporting statistical analysis are not reported in the registry record.
In general, statistical interpretation also depends on the population included in an analysis, the handling of missing observations, and the model used for repeated measurements. Those factors can affect an estimate and its uncertainty. The registry record does not report these details for the primary endpoint, so no assumptions about them should be made when interpreting the trial description.
9. Statistical Methods Explained
The registry identifies the primary measure as a mean of a continuous outcome and gives standard deviation as its dispersion measure. Those labels describe the type of summary intended, but the registry record does not report primary outcome summaries or a group comparison. The statistical concepts below are general explanations, not descriptions of analyses confirmed for REMOVAL.
What does a mean describe?
In general, a mean summarizes the central value of measurements in a group. For a continuous measure such as cIMT, it can describe the average wall thickness or average change under a particular definition. A mean is useful for expressing a group-level pattern, but it does not show the distribution of individual measurements. Participants may have values close to the mean or far from it, and the mean alone does not show that variation.
A standard deviation describes the spread of individual observations around a mean. A larger standard deviation indicates more dispersion in the measurements, while a smaller one indicates that observations are more clustered. Standard deviation is not the same as a confidence interval: the former describes variation among observations, while the latter describes uncertainty around an estimated quantity. The registry gives standard deviation as the dispersion type but does not report a value for the primary outcome.
Why do repeated measurements matter?
The endpoint is scheduled at baseline and at follow-up visits. In general, repeated measurements can help characterize the course of an outcome over time and can make use of information from more than one visit. A statistical analysis might compare change from baseline, compare group means at follow-up while accounting for baseline, or estimate a pattern across visits. Those are distinct analytical approaches, and the exact approach used in this trial is not reported in the registry record.
Repeated observations from the same participant are generally related to one another. An analysis that treats each observation as though it came from a different participant may fail to account for that within-person relationship. In general, longitudinal methods are designed to represent such dependence, but the specific method, assumptions, and covariance structure used for REMOVAL are not reported in the registry record. The outcome description alone does not establish which model was used.
What would a treatment contrast mean?
In a randomized trial, a treatment contrast compares outcomes in groups assigned to different interventions. For a continuous endpoint, this might be expressed as a difference in average outcomes or average changes, depending on the analysis definition. The interpretation depends on what quantity was estimated, which participants were included, and how follow-up measurements were handled. The registry record does not report a contrast estimate for cIMT, so no direction or magnitude can be described.
In general, a confidence interval communicates statistical uncertainty around an estimate. It is not a guarantee that the true value lies within the interval, nor does it summarize every source of uncertainty, such as measurement error or limitations in the analysis. A p-value, when reported, is a measure tied to a specified statistical model and null hypothesis; it is not a measure of clinical importance. Neither a confidence interval nor a p-value for the primary comparison is reported in the registry record.
Why can dispersion affect an analysis?
For a continuous measure, variability affects how precisely a group mean or group contrast can be estimated. Greater variability generally makes a given contrast harder to distinguish precisely from random variation, all else equal. This is a general statistical principle, not a claim about the observed variability in this trial, since primary outcome summaries are not reported.
Over-dispersion is most commonly discussed for count outcomes: it means that observed variation is greater than a model's assumed variation. If a count model fails to account for it, standard errors and uncertainty estimates may be misleading. This concept is less directly applicable to the continuous cIMT endpoint than to count outcomes. The registry record does not report a count-model analysis or a test for over-dispersion, and none should be inferred.
What does randomization contribute?
In general, random allocation is intended to make assigned groups comparable, on average, with respect to measured and unmeasured characteristics at the time of assignment. It supports interpretation of a between-group contrast as an effect of assignment, provided the analysis and follow-up preserve the relevant randomized comparison. Randomization does not ensure that every baseline characteristic is identical between groups, and it does not prevent missing data or departures from assigned treatment. The registry identifies the study as randomized but does not report the allocation sequence method or the primary analysis population.
The registry's design labels are randomized, triple-masked and parallel. These labels do not reveal the exact statistical plan. The model used for cIMT, the treatment of repeated observations, adjustment variables, handling of protocol deviations, and any sensitivity analyses are not reported in the registry record. A detailed interpretation of the trial's statistical findings would require those details alongside the numerical outcome estimates.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary outcome and several secondary outcome topics, including changes in HbA1c, LDL cholesterol, estimated glomerular filtration rate, weight, insulin dose and endothelial function, as well as retinopathy progression. Testing multiple outcomes can raise a multiplicity question: when many hypotheses are assessed, the chance of at least one apparently unusual result can increase. In general, trial protocols may address this through a prespecified hierarchy, adjusted significance thresholds, or by treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy or a hierarchy for the listed outcomes.
The registry record lists 8 outcome measures and 0 analyses. It does not report numerical results for the primary or secondary outcomes. It also does not report an analysis plan, the number of planned comparisons, or whether interim analyses were conducted. None of those details can be inferred from the outcome list or from the completed status.
Missing data can affect interpretation when participants do not have measurements at every planned visit. In general, the impact depends on how much data are missing, why they are missing, and the assumptions used by the analysis. Approaches can include analyses based on observed measurements, model-based methods, or sensitivity analyses that examine alternative assumptions. The registry record does not report the amount or pattern of missing cIMT data, the reasons for missingness, or the method used to handle it.
The analysis population is also not reported. A trial may analyze participants according to randomized assignment or use another defined population, but the registry record does not specify which approach was used for the primary outcome. It does not report participant flow by arm or the number assessed at each follow-up visit. Without these details and the outcome estimates, the extent to which missing data or analysis choices could affect the findings cannot be evaluated.
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 |
|---|---|---|---|
| Metformin | 34 | 219 | 15.5% |
| Placebo | 31 | 209 | 14.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Metformin | 5 of 219 |
| Placebo | 2 of 209 |
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 |
|---|---|
| Metformin | 112 of 219 |
| Placebo | 52 of 209 |
Most frequent serious adverse event terms
| Event term | Organ system | Metformin | Placebo |
|---|---|---|---|
| Metabolic and nutrition | Metabolism and nutrition disorders | 8 of 219 | 5 of 209 |
| Infections and Infestations | Infections and infestations | 7 of 219 | 5 of 209 |
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 6 of 219 | 3 of 209 |
| Gastrointestinal | Gastrointestinal disorders | 4 of 219 | 5 of 209 |
| Cardiac | Cardiac disorders | 3 of 219 | 6 of 209 |
| Respiratory | Respiratory, thoracic and mediastinal disorders | 1 of 219 | 5 of 209 |
| Injury | Injury, poisoning and procedural complications | 3 of 219 | 3 of 209 |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | 1 of 219 | 2 of 209 |
| Cerebrovascular accident | Nervous system disorders | 1 of 219 | 2 of 209 |
| Transient Ischaemic Attack | Nervous system disorders | 2 of 219 | 1 of 209 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Metformin | Placebo |
|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | 88 of 219 | 18 of 209 |
| Opthalmic adverse events | Eye disorders | 18 of 219 | 32 of 209 |
| Hypersensitivity to Metformin | Product Issues | 5 of 219 | 1 of 209 |
| Cardiovascular | Cardiac disorders | 1 of 219 | 1 of 209 |
| Neurological | Nervous system disorders | 0 of 219 | 0 of 209 |
Serious events with the highest arm-level rate: metabolic and nutrition (3.7%), infections and infestations (3.2%), cardiac (2.9%), neoplasms (2.7%), gastrointestinal (2.4%).
The registry record lists serious events and other events separately by treatment group. For serious events, it reports 34 affected among 219 at risk in the metformin group and 31 affected among 209 at risk in the placebo group. For other events, it reports 112 affected among 219 at risk in the metformin group and 52 affected among 209 at risk in the placebo group. These are counts of participants recorded as affected and the corresponding group counts at risk; they are not a cIMT result.
The record lists 5 deaths in the metformin group and 2 in the placebo group. It does not give additional context in the adverse-event fields about timing, cause, event-level detail, or attribution. The counts alone do not establish whether an event was caused by treatment. They also do not convey event duration, severity beyond the serious-event classification, or whether an individual experienced more than one event.
The listed serious-event terms include Metabolic and nutrition (3.7%), Infections and Infestations (3.2%), Cardiac (2.9%), Neoplasms (2.7%), Gastrointestinal (2.4%) and Respiratory (2.4%). The denominator and comparison basis for these percentages are not reported in the registry record. These term percentages should not be treated as a comparison between randomized groups or added together.
Safety counts are descriptive in the absence of information on event definitions, follow-up completeness, and a comparative statistical analysis. The registry record does not report a causal assessment or uncertainty estimates for these counts.
12. What the Result Does, and Does Not, Mean
The record establishes that REMOVAL was designed as a randomized comparison of metformin and placebo, added to titrated insulin therapy, in adults with confirmed type 1 diabetes aged 40 years and over who were at increased cardiovascular risk. It identifies averaged mean far wall common carotid artery intima-media thickness as the primary outcome and describes how and when that measure was intended to be collected.
It does not report the primary outcome estimate or a statistical comparison between groups. Thus the posted registry information does not show whether the groups had different cIMT changes, how large any difference was, or how precisely it was estimated. It cannot support a conclusion about the direction or clinical importance of a primary outcome effect. It also does not report numerical findings for the listed secondary outcomes.
In general, an outcome based on a vascular imaging measurement is not identical to a clinical event such as a cardiovascular complication. A change in a measurement can be informative about the biological or anatomical outcome being studied, but a result on that measure alone does not establish a corresponding change in other outcomes. This is a general distinction between surrogate or intermediate measures and clinical events; it is not a claim about an unreported REMOVAL result.
The listed safety counts offer descriptive information about participants recorded as affected, but do not establish causality or provide a complete comparison of risk. The registry record does not give enough analytical detail to determine how those events were collected or compared. Similarly, the completed status indicates trial status, not that every result is included in this record.
Accordingly, the record is useful for understanding the trial question, design, target population, outcome definition and selected safety counts. It is insufficient on its own for assessing the magnitude, precision or statistical significance of the primary comparison. Any interpretation of efficacy or comparative safety would require numerical results and details of the analyses, populations and missing-data handling, which are not reported in the registry record.
13. Why This Trial Matters Statistically
REMOVAL illustrates why a trial's question and its results must be read as separate pieces of evidence. The registry record describes a randomized, masked, parallel-group comparison and a continuous imaging endpoint, but does not report the primary treatment contrast. A clear outcome definition and design description are important, yet they cannot substitute for an estimate of what the groups experienced or how uncertain that estimate is.
The trial also highlights the statistical features of longitudinal measurement. cIMT was scheduled for assessment at baseline and repeated follow-up visits. Repeated data can describe change over time, but interpretation depends on the analysis definition and how the relationship between observations from the same participant is handled. Those decisions are not documented in the registry record. The endpoint's measurement schedule therefore makes the missing analysis details especially relevant.
The record lists secondary outcomes across metabolic, renal, ophthalmic, weight, insulin-dose and endothelial measures. A broad outcome set can be useful for examining different dimensions of a treatment strategy, while also raising questions about prespecification, multiplicity and how secondary findings should be interpreted. The record does not report those analytical safeguards or results.
Finally, the safety fields show why raw counts need context. Counts depend on the number of participants at risk and the way events are defined and followed. They do not by themselves establish causation or provide uncertainty around a comparative effect. In statistical reading, the design, outcome definitions, denominators, analysis plan and estimates all contribute to interpretation. REMOVAL's registry record supplies some of that framework but not the numerical primary results needed to assess the central comparison.
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 registry record does not report the primary cIMT results, a treatment-effect estimate, a confidence interval, or a p-value. It also does not report numerical findings for the listed secondary outcomes. This prevents assessment of the magnitude, direction and precision of the trial's principal comparison using this record alone.
The endpoint description is detailed about imaging and timing, but the registry record does not define the exact calculation of change or identify the statistical model used to compare groups. It does not say how repeated measurements were incorporated, whether baseline values were adjusted for, or how any departures from the planned visit schedule were handled. These are specific limitations for interpreting a multi-visit continuous outcome.
The record does not report participant numbers contributing to the primary analysis at each visit, the analysis population, or participant flow by group. It also does not report the extent, pattern or reasons for missing outcome data, or the methods used to address missingness. These omissions limit evaluation of whether the analyzed population and follow-up data could affect the comparison.
The registry identifies the study as randomized and triple-masked, but does not describe sequence generation, allocation concealment, masking procedures, or how masking was maintained. The placebo arm description is blank. The record also does not report adherence, treatment discontinuation, protocol deviations, or sensitivity analyses. These details should not be inferred from the design labels.
Several secondary outcomes are listed, but the statistical plan, multiplicity strategy, and any interim analyses are not reported in the registry record. The safety fields include counts and term percentages, but do not report denominator details for those term percentages, event timing, attribution, or comparative uncertainty. Together, these limitations mean that the record describes the study's intended comparison more fully than it documents the analyses and findings needed for a complete statistical appraisal.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) — NCT01483560.
- Registry record last updated 2019-06-19; status last verified 2019-06.
- Results first posted 2019-06-03.
- 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
REMOVAL, NCT01483560, is recorded as a completed phase 3 randomized, triple-masked, parallel-group trial sponsored by the University of Glasgow. The record lists enrollment of 493 participants and describes adults aged 40 years and over with confirmed type 1 diabetes and increased cardiovascular risk. The comparison was metformin added to titrated insulin therapy versus placebo with titrated insulin therapy.
The primary outcome was change in averaged mean far wall common carotid artery intima-media thickness, measured by ultrasound at baseline and at 12, 24 and 36 months. The registry record lists secondary metabolic, renal, retinal, weight, insulin-dose and endothelial outcomes and includes serious and other adverse-event counts.
The primary outcome estimate, statistical analysis, analysis population, missing-data handling and multiplicity approach are not reported in the registry record. As a result, the record documents the trial question and measurement plan but does not provide the numerical primary comparison needed to assess its direction or precision.