An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
NCT ID: NCT01892319
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2446 participants
OBSERVATIONAL
2013-09-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All patients
insulin detemir
Patients will be treated according to routine clinical practice at the discretion of the treating physician
other injectable antidiabetic treatment regimens
Patients will be treated according to routine clinical practice at the discretion of the treating physician
Interventions
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insulin detemir
Patients will be treated according to routine clinical practice at the discretion of the treating physician
other injectable antidiabetic treatment regimens
Patients will be treated according to routine clinical practice at the discretion of the treating physician
Eligibility Criteria
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Inclusion Criteria
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Pori, , Finland
Novo Nordisk Investigational Site
Tampere, , Finland
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Turku, , Finland
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Angers, , France
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Corbeil-Essonnes, , France
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Lille, , France
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Nîmes, , France
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Paris, , France
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Toulouse, , France
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Valenciennes, , France
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Bramsche, , Germany
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Eisenach, , Germany
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Essen, , Germany
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Friedrichsthal, , Germany
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Ludwigshafen, , Germany
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Neuwied, , Germany
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Speyer, , Germany
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Stuttgart, , Germany
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Sulzbach-Rosenberg, , Germany
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Athens, , Greece
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Nea Efkarpia - Thessaloniki, , Greece
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Castlebar, , Ireland
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Co. Donegal, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Petah Tikva, , Israel
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Livorno, , Italy
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Milan, , Italy
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Padua, , Italy
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Roma, , Italy
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Roma, , Italy
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Sant'Andrea Delle Fratte (PG), , Italy
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Torino, , Italy
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Trento, , Italy
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Verona, , Italy
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Alor Gajah, , Malaysia
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Alor Star, , Malaysia
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Alor Star, , Malaysia
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Batu Caves, , Malaysia
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Ipoh, , Malaysia
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Ipoh, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Putrajaya, , Malaysia
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Seremban, , Malaysia
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Seremban, , Malaysia
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Amsterdam, , Netherlands
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Apeldoorn, , Netherlands
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Arnhem, , Netherlands
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Eindhoven, , Netherlands
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Utrecht, , Netherlands
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Ålesund, , Norway
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Bergen, , Norway
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Gjøvik, , Norway
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Hamar, , Norway
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Lillehammer, , Norway
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Moss, , Norway
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Tønsberg, , Norway
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Legnica, , Poland
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Lodz, , Poland
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Lubin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Almada, , Portugal
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Amadora, , Portugal
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Leiria, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Galati, , Romania
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Valencia, , Spain
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Bath, , United Kingdom
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Belfast, , United Kingdom
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Bristol, , United Kingdom
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Devon, , United Kingdom
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Glasgow, , United Kingdom
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Inverness, , United Kingdom
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Southampton, , United Kingdom
Novo Nordisk Investigational Site
Stevenage, , United Kingdom
Countries
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References
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Mathiesen ER, Andersen H, Kring SI, Damm P. Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins. BMC Pregnancy Childbirth. 2017 Jan 18;17(1):38. doi: 10.1186/s12884-016-1177-4.
Thorius IH, Petersen J, Husemoen LLN, Alibegovic AC, Gall MA, Damm P, Mathiesen ER. Glycemic Control and Risk of Congenital Malformations in Women With Type 1 Diabetes. Obstet Gynecol. 2024 Nov 1;144(5):725-732. doi: 10.1097/AOG.0000000000005722. Epub 2024 Sep 5.
Mathiesen ER, Ali N, Alibegovic AC, Anastasiou E, Cypryk K, de Valk H, Dores J, Dunne F, Gall MA, Garcia SD, Hanaire HP, Husemoen LLN, Ivanisevic M, Kempe HP, McCance DR, Damm P. Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study. Diabetes Care. 2021 Sep;44(9):2069-2077. doi: 10.2337/dc21-0472. Epub 2021 Jul 30.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1132-9442
Identifier Type: OTHER
Identifier Source: secondary_id
ENCEPP/SDPP/4137
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN304-4016
Identifier Type: -
Identifier Source: org_study_id
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