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NCT01892319 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01892319
Other study ID # NN304-4016
Secondary ID U1111-1132-9442E
Status Completed
Phase
First received
Last updated
Start date September 30, 2013
Est. completion date September 30, 2019

Study information
Verified date November 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2446
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Croatia Novo Nordisk Investigational Site Zagreb
Finland Novo Nordisk Investigational Site Pori
Finland Novo Nordisk Investigational Site Tampere
Finland Novo Nordisk Investigational Site Turku
France Novo Nordisk Investigational Site Angers
France Novo Nordisk Investigational Site Corbeil Essonnes
France Novo Nordisk Investigational Site Lille
France Novo Nordisk Investigational Site Nimes
France Novo Nordisk Investigational Site Paris
France Novo Nordisk Investigational Site TOULOUSE cedex
France Novo Nordisk Investigational Site Valenciennes
Germany Novo Nordisk Investigational Site Bramsche
Germany Novo Nordisk Investigational Site Eisenach
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Ludwigshafen
Germany Novo Nordisk Investigational Site Neuwied
Germany Novo Nordisk Investigational Site Speyer
Germany Novo Nordisk Investigational Site Stuttgart
Germany Novo Nordisk Investigational Site Sulzbach-Rosenberg
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Nea Efkarpia - Thessaloniki
Ireland 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
Israel Novo Nordisk Investigational Site Petach Tikva
Italy Novo Nordisk Investigational Site Livorno
Italy Novo Nordisk Investigational Site Milano
Italy Novo Nordisk Investigational Site Padova
Italy Novo Nordisk Investigational Site Roma
Italy Novo Nordisk Investigational Site Roma
Italy Novo Nordisk Investigational Site Sant'Andrea Delle Fratte (PG)
Italy Novo Nordisk Investigational Site Torino
Italy Novo Nordisk Investigational Site Trento
Italy Novo Nordisk Investigational Site Verona
Malaysia Novo Nordisk Investigational Site Alor Gajah
Malaysia Novo Nordisk Investigational Site Alor Setar
Malaysia Novo Nordisk Investigational Site Alor Setar
Malaysia Novo Nordisk Investigational Site Batu Caves
Malaysia Novo Nordisk Investigational Site Ipoh
Malaysia Novo Nordisk Investigational Site Ipoh
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Malaysia Novo Nordisk Investigational Site Putrajaya
Malaysia Novo Nordisk Investigational Site Seremban
Malaysia Novo Nordisk Investigational Site Seremban
Netherlands Novo Nordisk Investigational Site Amsterdam
Netherlands Novo Nordisk Investigational Site Apeldoorn
Netherlands Novo Nordisk Investigational Site Arnhem
Netherlands Novo Nordisk Investigational Site Eindhoven
Netherlands Novo Nordisk Investigational Site Utrecht
Norway Novo Nordisk Investigational Site Ålesund
Norway Novo Nordisk Investigational Site Bergen
Norway Novo Nordisk Investigational Site Gjøvik
Norway Novo Nordisk Investigational Site Hamar
Norway Novo Nordisk Investigational Site Lillehammer
Norway Novo Nordisk Investigational Site Moss
Norway Novo Nordisk Investigational Site Tønsberg
Poland Novo Nordisk Investigational Site Legnica
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Lubin
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Szczecin
Portugal Novo Nordisk Investigational Site Almada
Portugal Novo Nordisk Investigational Site Amadora
Portugal Novo Nordisk Investigational Site Leiria
Portugal Novo Nordisk Investigational Site Lisboa
Portugal Novo Nordisk Investigational Site Lisboa
Portugal Novo Nordisk Investigational Site Porto
Portugal Novo Nordisk Investigational Site Porto
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Galati
Romania Novo Nordisk Investigational Site Timisoara Timis
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Valencia
United Kingdom Novo Nordisk Investigational Site Bath
United Kingdom Novo Nordisk Investigational Site Belfast
United Kingdom Novo Nordisk Investigational Site Bristol
United Kingdom Novo Nordisk Investigational Site Devon
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Inverness
United Kingdom Novo Nordisk Investigational Site Southampton
United Kingdom Novo Nordisk Investigational Site Stevenage

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Croatia,  Finland,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Malaysia,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Spain,  United Kingdom, 

References & Publications (1)

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 comparis — View Citation

Outcome
Type Measure Description Time frame Safety issue
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
Secondary Proportion of pregnancies complicated by pre-eclampsia During pregnancy
Secondary Proportion of pregnancies resulting in perinatal death Assessed 1 week after delivery
Secondary Proportion of pregnancies resulting in neonatal death Assessed 4 weeks after delivery
Secondary Proportion of pregnancies resulting in spontaneous abortion Assessed at pregnancy termination
Secondary Proportion of pregnancies resulting in pre-term delivery Assessed at delivery
Secondary Height At the age of 1 year
Secondary Weight At the age of 1 year
Secondary Proportion with changes (progression/regression) of major congenital malformations At the age of 1 year
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