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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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)

September 30, 2013

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (ESTIMATE)

July 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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