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 Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes (NCT03377699), a randomized phase 3 study. The primary outcome is Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03377699 |
| Phase | Phase 3 |
| Condition | Diabetes, Diabetes Mellitus, Type 1 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 225 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novo Nordisk A/S |
| Results posted | Yes |
2. Clinical Question
Population
Pregnant women with type 1 diabetes. The registry describes the analysis population as FASpregnant, which included all randomised pregnant women during the trial. The number analyzed for the primary endpoint would depend on participants with available data.
Intervention
Insulin degludec once daily, together with insulin aspart 2-4 times daily. Participants received pre-filled insulin pens and were expected to measure blood sugar several times a day, according to the study description.
Comparator
Insulin detemir once daily or twice daily, also together with insulin aspart 2-4 times daily. Treatment assignment was decided by chance.
Primary question
What was the last planned HbA1c measurement before delivery in each treatment group? The primary endpoint was the mean of HbA1c data collected at the gestational week corresponding to the last planned visit before delivery. The registry record does not report the group results or a numerical comparison.
This question concerns a continuous measure of glycaemia, rather than a yes-or-no clinical event. The comparison is framed around HbA1c measured late in pregnancy, with the specific measurement occasion depending on the planned visit before delivery. The trial also registered secondary outcomes concerning HbA1c thresholds, glucose measurements, hypoglycaemic episodes, retinopathy and adverse events. Those outcomes broaden the clinical scope, but they do not replace the stated primary question.
3. Trial Design
This was a Phase 3 randomized, parallel-group trial with no masking. The registry reports an enrollment of 225. Random allocation means the assigned treatment was decided by chance; a parallel design means the treatment groups were followed as separate groups rather than participants switching between the two assigned regimens. The registry record does not report the allocation ratio or the method used to generate or conceal assignments.
The comparison was between insulin degludec and insulin detemir, with insulin aspart used in both regimens. The listed schedules were degludec once daily and aspart 2-4 times daily, versus detemir once daily or twice daily and aspart 2-4 times daily. Because masking was none, participants and study personnel were not blinded to assigned treatment according to the registry’s design classification. The record does not describe any additional steps to reduce the influence of that knowledge on care or outcome assessment.
The study description says that participation would last between 10 and 25 months, depending on whether a participant was already pregnant when joining. The number of visits and tests, including blood and urine samples and ultrasound scans, also depended on pregnancy status at study start. The registry lists a start date of 2017-11-22, a primary completion date of 2020-12-17 and a completed status.
Enrollment is a design-record figure, not the number contributing data to every analysis. For the primary endpoint, the registry defines the analyzed number as participants with available data. The actual analyzed numbers for that endpoint are not reported in the registry record. It also does not report a sample-size justification or enough detail to reconstruct the allocation process.
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: Based on participant pregnancy status, either non-pregnant with the intention to become pregnant or pregnant from gestational Week (GW) 8-13 + 6 days were randomised in a 1:1 ratio to receive either Insulin Degludec (IDeg) or Insulin Detemir (IDet) in combination with Insulin Aspart (IAsp) as subcutaneous injection.
Overall Study
| Stage | IDeg | IDet |
|---|---|---|
| STARTED | 111 | 114 |
| Treated | 110 | 112 |
| SASpregnant | 91 | 94 |
| FASpregnant | 92 | 96 |
| COMPLETED | 89 | 89 |
| NOT COMPLETED | 22 | 25 |
Reasons for not completing this period:
| Reason | IDeg | IDet |
|---|---|---|
| Withdrawal by Subject | 2 | 9 |
| Lost to Follow-up | 1 | 1 |
| Commencement of medical infertility treatment during the course of the trial | 1 | 0 |
| Non-pregnant subject initiating medication contraindicated during pregnancy | 1 | 1 |
| Randomised non-pregnant did not become pregnant and withdrawn from trial | 11 | 8 |
| Randomised non-pregnant did not become pregnant and NOT withdrawn from trial | 6 | 6 |
Analysis population for the primary outcome, as defined in the registry: FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = participants with available data.
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: FASall: included all randomised women contributed to the evaluation.
| Characteristic | Unit | IDeg | IDet | Total |
|---|---|---|---|---|
| Participants analysed | 111 | 114 | 225 | |
| Age, Continuous | Years | 31.2 (SD 5.20) | 31.1 (SD 5.28) | 31.2 (SD 5.23) |
| Sex: Female, Male: Female | Participants | 111 | 114 | 225 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 24 | 14 | 38 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 87 | 100 | 187 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 106 | 108 | 214 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 5 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery, measured over From GW 16 to GW 36.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage glycosylated hemoglobin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the last planned glycosylated haemoglobin, or HbA1c, measurement prior to delivery. The registry describes it as the mean HbA1c data collected at the gestational week corresponding to the last planned visit before delivery. The eligible planned weeks were GW 16, 20, 24, 28, 32 or 36. The endpoint was specified as a continuous measure, summarized using a mean and standard deviation.
In general, HbA1c reflects glucose exposure over a period of time and is used to characterize longer-term glycaemic control, rather than a single blood glucose reading. A continuous endpoint can retain information about the measured level across participants, while a threshold outcome classifies values into categories. The registry also listed secondary outcomes based on HbA1c thresholds, but those are distinct from the primary continuous endpoint.
The primary endpoint used data from both the in-trial and on-treatment observation periods. The in-trial period began at randomization and ended at trial completion, up to 24 months. Trial completion was defined by the final scheduled follow-up visit, delivery + 58 days, or, for participants who did not attend that visit, the date of the last participant-investigator contact. The on-treatment period began with the first dose and ended on the last day on trial product, up to 22 months.
The endpoint definition is reported, but the group means, standard deviations and treatment comparison are not reported in the registry record. Without those results, the magnitude and precision of the observed HbA1c comparison cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison and defines a continuous primary endpoint, but it does not report the primary endpoint results. In particular, the record does not give the HbA1c mean or standard deviation for either treatment group, the number analyzed in each group, an estimated between-group contrast, or an uncertainty interval. It also does not report a statistical test or p-value for the primary endpoint. As a result, the direction, size and precision of the primary comparison cannot be described from the registry record.
In general, a difference between group means expresses how far apart the average measured outcomes are on the endpoint scale. A confidence interval, when reported, describes the range of values reasonably compatible with the data and the statistical model used. Neither an estimate nor its uncertainty is available for this primary outcome in the registry record. The absence of those results is not evidence that the groups were the same; it means the registry entry does not permit that comparison to be evaluated.
Randomization is intended to make treatment groups comparable, on average, with respect to factors present before assignment. That feature can support an interpretable treatment comparison when outcomes and analyses are reported. However, the trial was unmasked, and the registry record does not describe whether outcome assessment or other procedures were protected from knowledge of assignment. The outcome is a laboratory measure, but the record does not provide further information about laboratory procedures or analysis adjustments.
The registry lists an enrollment of 225, but that figure should not be mistaken for the number with observed primary endpoint data. The endpoint population is described as FASpregnant, and the analyzed number is defined as participants with available data. The specific analyzed numbers are not reported in the registry record. Nor does the entry describe how missing HbA1c measurements were handled.
Several secondary outcomes are listed, including HbA1c threshold outcomes, glucose measurements, hypoglycaemic episodes, retinopathy and adverse events. Their presence indicates that the study assessed more than the primary continuous measure; it does not establish the results of any of those assessments. Without numerical primary results and analysis details, the posted record supports a description of the study question and design, but not a conclusion about the comparative HbA1c findings.
9. Statistical Methods Explained
The registry describes the primary outcome as a mean of a continuous measure, with standard deviation as its dispersion statistic. That identifies the form of the endpoint summary, but not the complete statistical analysis. The specific model, any adjustment variables, the method used to estimate a treatment contrast and the approach to uncertainty are not reported in the registry record.
What does a mean and standard deviation describe?
In general, the mean represents the average measured value among the observations included in an analysis. The standard deviation describes how spread out those observations are around their mean. It is not the same as a confidence interval: the standard deviation describes variation among observed values, while a confidence interval describes uncertainty about an estimated quantity. The registry provides no primary-endpoint means or standard deviations, so these summaries cannot be interpreted for this comparison.
How does the endpoint timing work?
The endpoint is tied to each participant’s last planned HbA1c visit before delivery, rather than a single fixed gestational week for everyone. The registered possible weeks are GW 16, 20, 24, 28, 32 or 36. This definition makes the timing depend on the planned visit that occurred before delivery. The registry does not report how many participants contributed a value at each week or how differences in timing were handled in the statistical analysis.
The endpoint description says that data from both the in-trial and on-treatment observation periods were evaluated. These are defined as different periods: the in-trial period starts at randomization and can continue to trial completion, while the on-treatment period starts at the first dose and ends on the last day of trial product. The registry does not explain how results from these periods were combined or whether separate estimates were produced.
What does randomization contribute?
In general, random allocation is used to reduce systematic differences between treatment groups at the time of assignment. It does not guarantee that every characteristic will be balanced in a particular trial, and it cannot by itself address missing outcome data or differences that arise after assignment. The registry classifies this study as randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record.
The trial is listed as unmasked. In general, lack of masking can affect expectations, co-interventions, reporting or assessment, depending on the outcome and study procedures. HbA1c is a laboratory measure, but the record does not state whether laboratory personnel were masked or describe how samples were processed. No further claims about the impact of masking can be made from the registry entry.
What can be said about statistical testing?
The registry record does not report the primary comparison’s test, model, confidence interval, p-value or adjustment for baseline values. It also does not state whether assumptions for a particular model were checked. Those details matter because they determine how the estimate and its uncertainty are calculated. The endpoint’s mean and standard deviation summary alone is not enough to reproduce or evaluate an inferential analysis.
In general, a confidence interval helps readers assess both the plausible size of an effect and the precision of its estimate. A p-value addresses compatibility with a specified null model under the test’s assumptions, but does not describe effect size or clinical importance. Neither quantity is available for the primary comparison in the registry record. No claim about statistical significance or precision is therefore warranted.
How should planning illustrations be understood?
Any sample-size planning illustrations associated with the posted results are not the trial’s own design justification and are not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation and an effect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm for 80% or 90% power; time-to-event illustrations use a total number of events. These are planning calculations, not evidence about the trial’s actual power or its primary endpoint result.
The registry record does not report its original sample-size rationale, interim analyses or a complete statistical analysis plan. Such information would be needed to understand how the planned enrollment related to the primary endpoint and how the analysis was intended to address the registered outcomes.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 24 outcome measures and 2 analyses. The primary endpoint is described as the last planned HbA1c before delivery, with the measurement taken at one of several possible gestational weeks. The record notes that the primary outcome has several categories or time points and is not reduced to one comparison in the posted results. Consequently, the registry entry does not provide a single numerical primary comparison for interpretation.
In general, testing many outcomes or making multiple comparisons can increase the chance of at least one apparently unusual result arising by chance. Multiplicity procedures can address that issue, but the registry record does not report whether any adjustment was planned or used. It also does not identify a hierarchy among the secondary outcomes or explain how confirmatory and exploratory analyses were distinguished. The existence of multiple registered outcomes alone does not show that a particular correction was necessary or applied.
The primary analysis population is named FASpregnant and is defined as all randomised pregnant women during the trial. The record further states that the number analyzed is the number of participants with available data. It does not report the analyzed counts for the primary endpoint, the amount or pattern of missing HbA1c data, or the reasons measurements were unavailable.
Missing-data handling can affect an estimate if participants with observed outcomes differ systematically from those without them. In general, analysis methods may rely on assumptions about the relationship between missingness and observed or unobserved outcomes. The registry record does not specify an imputation method, a missing-data assumption, or a sensitivity analysis. It is therefore not possible to assess how missing measurements were handled or how robust the primary comparison would be to alternative assumptions.
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 |
|---|---|---|---|
| IDeg | 38 | 110 | 34.5% |
| IDet | 33 | 112 | 29.5% |
| IDegInf | 37 | 91 | 40.7% |
| IDetInf | 42 | 94 | 44.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IDeg | 0 of 110 |
| IDet | 0 of 112 |
| IDegInf | 4 of 91 |
| IDetInf | 7 of 94 |
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 |
|---|---|
| IDeg | 76 of 110 |
| IDet | 61 of 112 |
| IDegInf | 17 of 91 |
| IDetInf | 20 of 94 |
Most frequent serious adverse event terms
| Event term | Organ system | IDeg | IDet | IDegInf | IDetInf |
|---|---|---|---|---|---|
| Premature baby | Pregnancy, puerperium and perinatal conditions | 0 of 110 | 0 of 112 | 9 of 91 | 3 of 94 |
| Hypoglycaemia | Metabolism and nutrition disorders | 4 of 110 | 6 of 112 | 0 of 91 | 0 of 94 |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 0 of 110 | 0 of 112 | 9 of 91 | 1 of 94 |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | 3 of 110 | 6 of 112 | 0 of 91 | 0 of 94 |
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | 0 of 110 | 0 of 112 | 5 of 91 | 4 of 94 |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | 6 of 110 | 2 of 112 | 0 of 91 | 0 of 94 |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | 0 of 110 | 0 of 112 | 4 of 91 | 3 of 94 |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | 2 of 110 | 4 of 112 | 0 of 91 | 0 of 94 |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | 0 of 110 | 0 of 112 | 1 of 91 | 5 of 94 |
| Sepsis neonatal | Infections and infestations | 0 of 110 | 0 of 112 | 5 of 91 | 1 of 94 |
Most frequent non-serious adverse event terms
| Event term | Organ system | IDeg | IDet | IDegInf | IDetInf |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 21 of 110 | 23 of 112 | 0 of 91 | 0 of 94 |
| Anaemia | Blood and lymphatic system disorders | 22 of 110 | 16 of 112 | 0 of 91 | 0 of 94 |
| Urinary tract infection | Infections and infestations | 11 of 110 | 9 of 112 | 0 of 91 | 0 of 94 |
| Headache | Nervous system disorders | 8 of 110 | 10 of 112 | 0 of 91 | 0 of 94 |
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | 6 of 110 | 8 of 112 | 1 of 91 | 0 of 94 |
| Vomiting | Gastrointestinal disorders | 8 of 110 | 6 of 112 | 1 of 91 | 0 of 94 |
| Nausea | Gastrointestinal disorders | 7 of 110 | 7 of 112 | 0 of 91 | 0 of 94 |
| Hypoglycaemia | Metabolism and nutrition disorders | 0 of 110 | 0 of 112 | 6 of 91 | 8 of 94 |
| Influenza | Infections and infestations | 5 of 110 | 7 of 112 | 0 of 91 | 0 of 94 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 5 of 110 | 7 of 112 | 0 of 91 | 0 of 94 |
Serious events with the highest arm-level rate: neonatal respiratory distress syndrome (9.9%), premature baby (9.9%), hypoglycaemia neonatal (5.5%), sepsis neonatal (5.5%), pre-eclampsia (5.5%).
The registry lists serious adverse event figures under four group labels: IDeg, IDet, IDegInf and IDetInf. For these groups respectively, the number at risk for serious events was 110, 112, 91 and 94, and the number affected was 38, 33, 37 and 42. The listed death counts were 0, 0, 4 and 7. These are registry group entries and should be read as recorded, without assuming that the differently labelled groups represent interchangeable populations.
For other adverse events, the corresponding at-risk counts were 110, 112, 91 and 94, and the affected counts were 76, 61, 17 and 20. The registry record does not provide further definitions for the group-label suffixes in the registry record recorded for this analysis. It also does not state whether an affected participant could contribute more than one event, or describe exposure time for these figures. Therefore the counts should not be converted into rates or treated as a direct measure of comparative risk.
The record lists neonatal respiratory distress syndrome and premature baby at 9.9% each; hypoglycaemia neonatal, sepsis neonatal and pre-eclampsia at 5.5% each; and gestational hypertension at 5.4% among the top serious terms. The denominator and group-specific breakdown for these percentages are not reported in the registry record. Counts and percentages can describe recorded events, but without definitions, denominators and a complete comparison they do not establish that one regimen caused more or fewer events.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare two insulin regimens in pregnant women with type 1 diabetes, with the primary endpoint defined as the last planned HbA1c measurement before delivery. It also records secondary outcomes and adverse-event information. It does not report the numerical primary endpoint results, so the size, direction and precision of the HbA1c comparison cannot be stated.
That distinction matters: a registered question is not the same as a reported finding. The endpoint definition tells readers what was intended to be measured, but not what values were observed. Without group summaries and an estimate of the between-group comparison, the record cannot show how the groups differed on the primary measure. The absence of a reported comparison does not establish equality, benefit or harm.
The adverse-event counts and listed serious-event terms provide descriptive safety information as recorded in the registry. They do not, by themselves, establish comparative safety. The group labels, denominators for the listed percentages, event-exposure details and a complete statistical comparison are not reported in the registry record. The figures should therefore be read as recorded event counts and terms, not as proof of a causal difference between treatments.
More broadly, a trial’s findings depend on who contributed data, how missing observations were handled, which comparisons were planned and how uncertainty was estimated. The registry describes the FASpregnant population and defines analyzed participants as those with available data, but it does not give the primary analyzed counts or missing-data methods. Those omissions limit what can be concluded from this record.
The study’s randomized design is relevant to how a treatment comparison might be interpreted when results and methods are fully reported. It does not fill in missing estimates or remove uncertainty about the unreported analysis. The appropriate reading is therefore focused: the registry records the question, design, endpoint definition and some safety counts, while the primary comparative result and important analysis details are not reported.
13. Why This Trial Matters Statistically
This trial raises a statistical question that is more specific than whether two medicines were compared: it concerns a continuous HbA1c measure taken at the last planned visit before delivery, with that visit potentially occurring at different gestational weeks. The endpoint definition and timing are important to understanding what the intended comparison represents. They also make clear why a result needs to be accompanied by information about when measurements were obtained and how the varying visit timing entered the analysis.
The randomized, parallel design provides a framework for comparing assigned regimens, while the unmasked design is relevant context for interpreting how the study was conducted. Statistical interpretation also requires the analyzed population, the amount of available endpoint data, an estimate of the group contrast and a measure of its uncertainty. The registry record does not report those primary results or several of those analysis details.
The trial also illustrates why a broad outcome list does not substitute for a clearly reported primary comparison. The registry lists 24 outcome measures and notes that the primary outcome has several categories or time points, rather than presenting one comparison. Without a reported multiplicity plan, readers cannot determine how the range of registered outcomes was handled statistically.
Finally, the adverse-event entries show why counts need context. At-risk numbers, event counts, group definitions, denominators and exposure information all contribute to interpretation. The record contains some counts and selected percentages, but not all the detail needed for a comparative safety assessment. These features make the trial statistically informative as an example of the questions that endpoint definitions and transparent reporting must answer, even though the posted record does not allow the primary treatment comparison to be quantified.
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.
A central limitation is that the registry record does not report the primary HbA1c results. The group means, standard deviations, numbers analyzed, estimated contrast and uncertainty are absent. This prevents assessment of the observed difference and its precision, regardless of the randomized design.
The endpoint is selected according to the last planned visit before delivery, and the possible measurement weeks range from GW 16 to GW 36. The record does not report how many observations came from each week or how the timing variation was addressed analytically. It also does not provide a primary comparison reduced to one estimate, noting instead that the outcome has several categories or time points.
Although FASpregnant is defined, the number with available primary endpoint data is not reported. The registry entry does not describe missingness, reasons for unavailable measurements, imputation, assumptions about missing data or sensitivity analyses. These omissions make it impossible to evaluate whether the analyzed data represent the intended population adequately.
The trial is classified as unmasked, but details about outcome assessment, laboratory procedures and safeguards against bias are not reported in the registry record. The allocation ratio, sequence-generation method, concealment procedures, statistical model, covariate adjustment, interim analyses and original sample-size justification are also not reported. These details would help readers evaluate trial conduct and the prespecification of analyses.
Safety interpretation is limited by the absence of further definitions for the group labels, exposure-time information and denominator details for the listed serious-event percentages. The record also does not provide a complete comparative analysis of those events. These limitations are specific to what the registry entry reports and should not be mistaken for evidence that the underlying study did or did not collect additional information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes — NCT03377699.
- Registry record last updated 2023-01-20; status last verified 2023-01.
- Results first posted 2022-04-27.
- 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
NCT03377699 is a completed Phase 3 randomized, parallel-group trial with no masking. It enrolled 225 and compared insulin degludec with insulin detemir, with insulin aspart used alongside both regimens, in pregnant women with type 1 diabetes. The primary endpoint was the last planned HbA1c measurement before delivery, summarized as a mean and standard deviation.
The registry describes FASpregnant as all randomised pregnant women during the trial and defines the analyzed number as participants with available data. It lists secondary glycaemic, pregnancy and safety outcomes, as well as serious and other adverse-event counts. However, the primary group results, the treatment contrast, its uncertainty and key analysis details are not reported in the registry record. The registered design and endpoint can be described, but the primary comparative result cannot be interpreted from this record.