An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

November 18, 2019 updated by: Novo Nordisk A/S

An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • Finland
      • Pori, Finland, 28500
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33521
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20520
        • Novo Nordisk Investigational Site
  • France
      • Angers, France, 49000
        • Novo Nordisk Investigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Paris, France, 75014
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31054
        • Novo Nordisk Investigational Site
      • Valenciennes, France, 59322
        • Novo Nordisk Investigational Site
  • Germany
      • Bramsche, Germany, 49565
        • Novo Nordisk Investigational Site
      • Eisenach, Germany, 99817
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45136
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70184
        • Novo Nordisk Investigational Site
      • Sulzbach-Rosenberg, Germany, 92237
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11528
        • Novo Nordisk Investigational Site
      • Nea Efkarpia - Thessaloniki, Greece, GR-56403
        • Novo Nordisk Investigational Site
  • Ireland
      • Castlebar, Ireland
        • Novo Nordisk Investigational Site
      • Co. Donegal, Ireland
        • Novo Nordisk Investigational Site
      • Dublin 2, Ireland
        • Novo Nordisk Investigational Site
      • Galway, Ireland, H91 YR71
        • Novo Nordisk Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
  • Italy
      • Livorno, Italy, 57124
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Padova, Italy, 35143
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00189
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00195
        • Novo Nordisk Investigational Site
      • Sant'Andrea Delle Fratte (PG), Italy, 06129
        • Novo Nordisk Investigational Site
      • Torino, Italy, 10126
        • Novo Nordisk Investigational Site
      • Trento, Italy, 38122
        • Novo Nordisk Investigational Site
      • Verona, Italy, 37126
        • Novo Nordisk Investigational Site
  • Malaysia
      • Alor Gajah, Malaysia, 78300
        • Novo Nordisk Investigational Site
      • Alor Setar, Malaysia, 05460
        • Novo Nordisk Investigational Site
      • Alor Setar, Malaysia, 05400
        • Novo Nordisk Investigational Site
      • Batu Caves, Malaysia, 68100
        • Novo Nordisk Investigational Site
      • Ipoh, Malaysia, 30450
        • Novo Nordisk Investigational Site
      • Ipoh, Malaysia, 31400
        • Novo Nordisk Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Novo Nordisk Investigational Site
      • Kuala Lumpur, Malaysia, 52000
        • Novo Nordisk Investigational Site
      • Kuala Lumpur, Malaysia, 57000
        • Novo Nordisk Investigational Site
      • Putrajaya, Malaysia, 62250
        • Novo Nordisk Investigational Site
      • Seremban, Malaysia, 70300
        • Novo Nordisk Investigational Site
      • Seremban, Malaysia, 70450
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Arnhem, Netherlands, 6815 AD
        • Novo Nordisk Investigational Site
      • Eindhoven, Netherlands, 5631 BM
        • Novo Nordisk Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Hamar, Norway, 2318
        • Novo Nordisk Investigational Site
      • Lillehammer, Norway, 2609
        • Novo Nordisk Investigational Site
      • Moss, Norway, 1535
        • Novo Nordisk Investigational Site
      • Tønsberg, Norway, 3116
        • Novo Nordisk Investigational Site
      • Ålesund, Norway, 6026
        • Novo Nordisk Investigational Site
  • Poland
      • Legnica, Poland, 59-220
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-553
        • Novo Nordisk Investigational Site
      • Lubin, Poland, 59-300
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-371
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 61-693
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 70-376
        • Novo Nordisk Investigational Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Novo Nordisk Investigational Site
      • Amadora, Portugal, 2720-276
        • Novo Nordisk Investigational Site
      • Leiria, Portugal, 2410-197
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1649-035
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1069-089
        • Novo Nordisk Investigational Site
      • Porto, Portugal, 4200-319
        • Novo Nordisk Investigational Site
      • Porto, Portugal, 4099-001
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 020042
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020475
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020359
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 022441
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800098
        • Novo Nordisk Investigational Site
    • Timis
      • Timisoara, Timis, Romania, 300736
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08025
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29006
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41014
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Novo Nordisk Investigational Site
      • Belfast, United Kingdom, BT12 6BA
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Devon, United Kingdom, EX2 5DW
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G31 2ER
        • Novo Nordisk Investigational Site
      • Inverness, United Kingdom, IV2 3JH
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO16 5YA
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with diabetes mellitus, who are pregnant and treated with Levemir® or other injectable antidiabetic treatment regimens, and who have not changed basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception will be included in the Diabetes Pregnancy Registry.

Description

Inclusion Criteria: - Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception Exclusion Criteria: - Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All patients
Drug: insulin detemir
Patients will be treated according to routine clinical practice at the discretion of the treating physician
Drug: other injectable antidiabetic treatment regimens
Patients will be treated according to routine clinical practice at the discretion of the treating physician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death
Time Frame: Assessed up to 4 weeks after delivery
Assessed up to 4 weeks after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of major hypoglycaemia
Time Frame: During pregnancy
During pregnancy
Proportion of pregnancies complicated by pre-eclampsia
Time Frame: During pregnancy
During pregnancy
Proportion of pregnancies resulting in perinatal death
Time Frame: Assessed 1 week after delivery
Assessed 1 week after delivery
Proportion of pregnancies resulting in neonatal death
Time Frame: Assessed 4 weeks after delivery
Assessed 4 weeks after delivery
Proportion of pregnancies resulting in spontaneous abortion
Time Frame: Assessed at pregnancy termination
Assessed at pregnancy termination
Proportion of pregnancies resulting in pre-term delivery
Time Frame: Assessed at delivery
Assessed at delivery
Height
Time Frame: At the age of 1 year
At the age of 1 year
Weight
Time Frame: At the age of 1 year
At the age of 1 year
Proportion with changes (progression/regression) of major congenital malformations
Time Frame: At the age of 1 year
At the age of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN304-4016
  • U1111-1132-9442 (OTHER: WHO)
  • ENCEPP/SDPP/4137 (REGISTRY: EU PAS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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