Clinical trial NCT01892319: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Official title: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-07-04
Enrollment: 2446
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Assessed up to 4 weeks after delivery
Secondary outcomes:
measure: Incidence of major hypoglycaemia
timeFrame: During pregnancy
measure: Proportion of pregnancies complicated by pre-eclampsia
timeFrame: During pregnancy
measure: Proportion of pregnancies resulting in perinatal death
timeFrame: Assessed 1 week after delivery
measure: Proportion of pregnancies resulting in neonatal death
timeFrame: Assessed 4 weeks after delivery
measure: Proportion of pregnancies resulting in spontaneous abortion
timeFrame: Assessed at pregnancy termination
measure: Proportion of pregnancies resulting in pre-term delivery
timeFrame: Assessed at delivery
measure: Height
timeFrame: At the age of 1 year
measure: Weight
timeFrame: At the age of 1 year
measure: Proportion with changes (progression/regression) of major congenital malformations
timeFrame: At the age of 1 year
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Pori
country: Finland
facility: Novo Nordisk Investigational Site
city: Tampere
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Angers
country: France
facility: Novo Nordisk Investigational Site
city: Corbeil Essonnes
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Nimes
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: TOULOUSE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Valenciennes
country: France
facility: Novo Nordisk Investigational Site
city: Bramsche
country: Germany
facility: Novo Nordisk Investigational Site
city: Eisenach
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Nea Efkarpia - Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Castlebar
country: Ireland
facility: Novo Nordisk Investigational Site
city: Co. Donegal
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin 2
country: Ireland
facility: Novo Nordisk Investigational Site
city: Galway
country: Ireland
facility: Novo Nordisk Investigational Site
city: Petach Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Livorno
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Sant'Andrea Delle Fratte (PG)
country: Italy
facility: Novo Nordisk Investigational Site
city: Torino
country: Italy
facility: Novo Nordisk Investigational Site
city: Trento
country: Italy
facility: Novo Nordisk Investigational Site
city: Verona
country: Italy
facility: Novo Nordisk Investigational Site
city: Alor Gajah
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Alor Setar
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Alor Setar
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Batu Caves
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Ipoh
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Ipoh
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Putrajaya
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Seremban
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Seremban
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Arnhem
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Gjøvik
country: Norway
facility: Novo Nordisk Investigational Site
city: Hamar
country: Norway
facility: Novo Nordisk Investigational Site
city: Lillehammer
country: Norway
facility: Novo Nordisk Investigational Site
city: Moss
country: Norway
facility: Novo Nordisk Investigational Site
city: Tønsberg
country: Norway
facility: Novo Nordisk Investigational Site
city: Ålesund
country: Norway
facility: Novo Nordisk Investigational Site
city: Legnica
country: Poland
facility: Novo Nordisk Investigational Site
city: Lodz
country: Poland
facility: Novo Nordisk Investigational Site
city: Lubin
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Szczecin
country: Poland
facility: Novo Nordisk Investigational Site
city: Almada
country: Portugal
facility: Novo Nordisk Investigational Site
city: Amadora
country: Portugal
facility: Novo Nordisk Investigational Site
city: Leiria
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
facility: Novo Nordisk Investigational Site
state: Timis
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Galati
country: Romania
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Devon
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Inverness
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Stevenage
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.