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Clinical Trial Details

Trial ID: L4333
Source ID: NCT01892319
Associated Drug: Insulin Detemir
Title: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir|DRUG: other injectable antidiabetic treatment regimens
Outcome Measures: Primary: 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, Assessed up to 4 weeks after delivery | Secondary: Incidence of major hypoglycaemia, During pregnancy|Proportion of pregnancies complicated by pre-eclampsia, During pregnancy|Proportion of pregnancies resulting in perinatal death, Assessed 1 week after delivery|Proportion of pregnancies resulting in neonatal death, Assessed 4 weeks after delivery|Proportion of pregnancies resulting in spontaneous abortion, Assessed at pregnancy termination|Proportion of pregnancies resulting in pre-term delivery, Assessed at delivery|Height, At the age of 1 year|Weight, At the age of 1 year|Proportion with changes (progression/regression) of major congenital malformations, At the age of 1 year
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 2446
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2013-09-30
Completion Date: 2019-09-30
Results First Posted:
Last Update Posted: 2019-11-19
Locations: Novo Nordisk Investigational Site, Zagreb, 10000, Croatia|Novo Nordisk Investigational Site, Pori, 28500, Finland|Novo Nordisk Investigational Site, Tampere, 33521, Finland|Novo Nordisk Investigational Site, Turku, 20520, Finland|Novo Nordisk Investigational Site, Angers, 49000, France|Novo Nordisk Investigational Site, Corbeil Essonnes, 91106, France|Novo Nordisk Investigational Site, Lille, 59037, France|Novo Nordisk Investigational Site, Nimes, 30006, France|Novo Nordisk Investigational Site, Paris, 75014, France|Novo Nordisk Investigational Site, TOULOUSE cedex, 31054, France|Novo Nordisk Investigational Site, Valenciennes, 59322, France|Novo Nordisk Investigational Site, Bramsche, 49565, Germany|Novo Nordisk Investigational Site, Eisenach, 99817, Germany|Novo Nordisk Investigational Site, Essen, 45136, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Speyer, 67346, Germany|Novo Nordisk Investigational Site, Stuttgart, 70184, Germany|Novo Nordisk Investigational Site, Sulzbach-Rosenberg, 92237, Germany|Novo Nordisk Investigational Site, Athens, GR-11528, Greece|Novo Nordisk Investigational Site, Nea Efkarpia - Thessaloniki, GR-56403, Greece|Novo Nordisk Investigational Site, Castlebar, Ireland|Novo Nordisk Investigational Site, Co. Donegal, Ireland|Novo Nordisk Investigational Site, Dublin 2, Ireland|Novo Nordisk Investigational Site, Galway, H91 YR71, Ireland|Novo Nordisk Investigational Site, Petach Tikva, 49100, Israel|Novo Nordisk Investigational Site, Livorno, 57124, Italy|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Padova, 35143, Italy|Novo Nordisk Investigational Site, Roma, 00189, Italy|Novo Nordisk Investigational Site, Roma, 00195, Italy|Novo Nordisk Investigational Site, Sant'Andrea Delle Fratte (PG), 06129, Italy|Novo Nordisk Investigational Site, Torino, 10126, Italy|Novo Nordisk Investigational Site, Trento, 38122, Italy|Novo Nordisk Investigational Site, Verona, 37126, Italy|Novo Nordisk Investigational Site, Alor Gajah, 78300, Malaysia|Novo Nordisk Investigational Site, Alor Setar, 05400, Malaysia|Novo Nordisk Investigational Site, Alor Setar, 05460, Malaysia|Novo Nordisk Investigational Site, Batu Caves, 68100, Malaysia|Novo Nordisk Investigational Site, Ipoh, 30450, Malaysia|Novo Nordisk Investigational Site, Ipoh, 31400, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, 52000, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, 57000, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, 59100, Malaysia|Novo Nordisk Investigational Site, Putrajaya, 62250, Malaysia|Novo Nordisk Investigational Site, Seremban, 70300, Malaysia|Novo Nordisk Investigational Site, Seremban, 70450, Malaysia|Novo Nordisk Investigational Site, Amsterdam, 1081 HV, Netherlands|Novo Nordisk Investigational Site, Apeldoorn, 7334 DZ, Netherlands|Novo Nordisk Investigational Site, Arnhem, 6815 AD, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5631 BM, Netherlands|Novo Nordisk Investigational Site, Utrecht, 3584 CX, Netherlands|Novo Nordisk Investigational Site, Bergen, 5021, Norway|Novo Nordisk Investigational Site, Gjøvik, NO-2819, Norway|Novo Nordisk Investigational Site, Hamar, 2318, Norway|Novo Nordisk Investigational Site, Lillehammer, 2609, Norway|Novo Nordisk Investigational Site, Moss, 1535, Norway|Novo Nordisk Investigational Site, Tønsberg, 3116, Norway|Novo Nordisk Investigational Site, Ålesund, 6026, Norway|Novo Nordisk Investigational Site, Legnica, 59-220, Poland|Novo Nordisk Investigational Site, Lodz, 90-553, Poland|Novo Nordisk Investigational Site, Lubin, 59-300, Poland|Novo Nordisk Investigational Site, Poznan, 60-371, Poland|Novo Nordisk Investigational Site, Poznan, 61-693, Poland|Novo Nordisk Investigational Site, Szczecin, 70-376, Poland|Novo Nordisk Investigational Site, Almada, 2805-267, Portugal|Novo Nordisk Investigational Site, Amadora, 2720-276, Portugal|Novo Nordisk Investigational Site, Leiria, 2410-197, Portugal|Novo Nordisk Investigational Site, Lisboa, 1069-089, Portugal|Novo Nordisk Investigational Site, Lisboa, 1649-035, Portugal|Novo Nordisk Investigational Site, Porto, 4099-001, Portugal|Novo Nordisk Investigational Site, Porto, 4200-319, Portugal|Novo Nordisk Investigational Site, Timisoara, Timis, 300736, Romania|Novo Nordisk Investigational Site, Bucharest, 020042, Romania|Novo Nordisk Investigational Site, Bucharest, 020359, Romania|Novo Nordisk Investigational Site, Bucharest, 020475, Romania|Novo Nordisk Investigational Site, Bucharest, 022441, Romania|Novo Nordisk Investigational Site, Galati, 800098, Romania|Novo Nordisk Investigational Site, Barcelona, 08025, Spain|Novo Nordisk Investigational Site, Barcelona, 08036, Spain|Novo Nordisk Investigational Site, Madrid, 28046, Spain|Novo Nordisk Investigational Site, Málaga, 29006, Spain|Novo Nordisk Investigational Site, Sevilla, 41014, Spain|Novo Nordisk Investigational Site, Valencia, 46026, Spain|Novo Nordisk Investigational Site, Bath, BA1 3NG, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT12 6BA, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Devon, EX2 5DW, United Kingdom|Novo Nordisk Investigational Site, Glasgow, G31 2ER, United Kingdom|Novo Nordisk Investigational Site, Inverness, IV2 3JH, United Kingdom|Novo Nordisk Investigational Site, Southampton, SO16 5YA, United Kingdom|Novo Nordisk Investigational Site, Stevenage, SG1 4AB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01892319