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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01892319
Collaborator
(none)
2,446
Enrollment
93
Locations
72
Actual Duration (Months)
26.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: insulin detemir
  • Drug: other injectable antidiabetic treatment regimens

Study Design

Study Type:
Observational
Actual Enrollment :
2446 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus
Actual Study Start Date :
Sep 30, 2013
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Incidence of major hypoglycaemia [During pregnancy]

  2. Proportion of pregnancies complicated by pre-eclampsia [During pregnancy]

  3. Proportion of pregnancies resulting in perinatal death [Assessed 1 week after delivery]

  4. Proportion of pregnancies resulting in neonatal death [Assessed 4 weeks after delivery]

  5. Proportion of pregnancies resulting in spontaneous abortion [Assessed at pregnancy termination]

  6. Proportion of pregnancies resulting in pre-term delivery [Assessed at delivery]

  7. Height [At the age of 1 year]

  8. Weight [At the age of 1 year]

  9. Proportion with changes (progression/regression) of major congenital malformations [At the age of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Zagreb Croatia 10000
2 Novo Nordisk Investigational Site Pori Finland 28500
3 Novo Nordisk Investigational Site Tampere Finland 33521
4 Novo Nordisk Investigational Site Turku Finland 20520
5 Novo Nordisk Investigational Site Angers France 49000
6 Novo Nordisk Investigational Site Corbeil Essonnes France 91106
7 Novo Nordisk Investigational Site Lille France 59037
8 Novo Nordisk Investigational Site Nimes France 30006
9 Novo Nordisk Investigational Site Paris France 75014
10 Novo Nordisk Investigational Site TOULOUSE cedex France 31054
11 Novo Nordisk Investigational Site Valenciennes France 59322
12 Novo Nordisk Investigational Site Bramsche Germany 49565
13 Novo Nordisk Investigational Site Eisenach Germany 99817
14 Novo Nordisk Investigational Site Essen Germany 45136
15 Novo Nordisk Investigational Site Friedrichsthal Germany 66299
16 Novo Nordisk Investigational Site Ludwigshafen Germany 67059
17 Novo Nordisk Investigational Site Neuwied Germany 56564
18 Novo Nordisk Investigational Site Speyer Germany 67346
19 Novo Nordisk Investigational Site Stuttgart Germany 70184
20 Novo Nordisk Investigational Site Sulzbach-Rosenberg Germany 92237
21 Novo Nordisk Investigational Site Athens Greece GR-11528
22 Novo Nordisk Investigational Site Nea Efkarpia - Thessaloniki Greece GR-56403
23 Novo Nordisk Investigational Site Castlebar Ireland
24 Novo Nordisk Investigational Site Co. Donegal Ireland
25 Novo Nordisk Investigational Site Dublin 2 Ireland
26 Novo Nordisk Investigational Site Galway Ireland H91 YR71
27 Novo Nordisk Investigational Site Petach Tikva Israel 49100
28 Novo Nordisk Investigational Site Livorno Italy 57124
29 Novo Nordisk Investigational Site Milano Italy 20132
30 Novo Nordisk Investigational Site Padova Italy 35143
31 Novo Nordisk Investigational Site Roma Italy 00189
32 Novo Nordisk Investigational Site Roma Italy 00195
33 Novo Nordisk Investigational Site Sant'Andrea Delle Fratte (PG) Italy 06129
34 Novo Nordisk Investigational Site Torino Italy 10126
35 Novo Nordisk Investigational Site Trento Italy 38122
36 Novo Nordisk Investigational Site Verona Italy 37126
37 Novo Nordisk Investigational Site Alor Gajah Malaysia 78300
38 Novo Nordisk Investigational Site Alor Setar Malaysia 05400
39 Novo Nordisk Investigational Site Alor Setar Malaysia 05460
40 Novo Nordisk Investigational Site Batu Caves Malaysia 68100
41 Novo Nordisk Investigational Site Ipoh Malaysia 30450
42 Novo Nordisk Investigational Site Ipoh Malaysia 31400
43 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 52000
44 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 57000
45 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 59100
46 Novo Nordisk Investigational Site Putrajaya Malaysia 62250
47 Novo Nordisk Investigational Site Seremban Malaysia 70300
48 Novo Nordisk Investigational Site Seremban Malaysia 70450
49 Novo Nordisk Investigational Site Amsterdam Netherlands 1081 HV
50 Novo Nordisk Investigational Site Apeldoorn Netherlands 7334 DZ
51 Novo Nordisk Investigational Site Arnhem Netherlands 6815 AD
52 Novo Nordisk Investigational Site Eindhoven Netherlands 5631 BM
53 Novo Nordisk Investigational Site Utrecht Netherlands 3584 CX
54 Novo Nordisk Investigational Site Bergen Norway 5021
55 Novo Nordisk Investigational Site Gjøvik Norway NO-2819
56 Novo Nordisk Investigational Site Hamar Norway 2318
57 Novo Nordisk Investigational Site Lillehammer Norway 2609
58 Novo Nordisk Investigational Site Moss Norway 1535
59 Novo Nordisk Investigational Site Tønsberg Norway 3116
60 Novo Nordisk Investigational Site Ålesund Norway 6026
61 Novo Nordisk Investigational Site Legnica Poland 59-220
62 Novo Nordisk Investigational Site Lodz Poland 90-553
63 Novo Nordisk Investigational Site Lubin Poland 59-300
64 Novo Nordisk Investigational Site Poznan Poland 60-371
65 Novo Nordisk Investigational Site Poznan Poland 61-693
66 Novo Nordisk Investigational Site Szczecin Poland 70-376
67 Novo Nordisk Investigational Site Almada Portugal 2805-267
68 Novo Nordisk Investigational Site Amadora Portugal 2720-276
69 Novo Nordisk Investigational Site Leiria Portugal 2410-197
70 Novo Nordisk Investigational Site Lisboa Portugal 1069-089
71 Novo Nordisk Investigational Site Lisboa Portugal 1649-035
72 Novo Nordisk Investigational Site Porto Portugal 4099-001
73 Novo Nordisk Investigational Site Porto Portugal 4200-319
74 Novo Nordisk Investigational Site Timisoara Timis Romania 300736
75 Novo Nordisk Investigational Site Bucharest Romania 020042
76 Novo Nordisk Investigational Site Bucharest Romania 020359
77 Novo Nordisk Investigational Site Bucharest Romania 020475
78 Novo Nordisk Investigational Site Bucharest Romania 022441
79 Novo Nordisk Investigational Site Galati Romania 800098
80 Novo Nordisk Investigational Site Barcelona Spain 08025
81 Novo Nordisk Investigational Site Barcelona Spain 08036
82 Novo Nordisk Investigational Site Madrid Spain 28046
83 Novo Nordisk Investigational Site Málaga Spain 29006
84 Novo Nordisk Investigational Site Sevilla Spain 41014
85 Novo Nordisk Investigational Site Valencia Spain 46026
86 Novo Nordisk Investigational Site Bath United Kingdom BA1 3NG
87 Novo Nordisk Investigational Site Belfast United Kingdom BT12 6BA
88 Novo Nordisk Investigational Site Bristol United Kingdom BS10 5NB
89 Novo Nordisk Investigational Site Devon United Kingdom EX2 5DW
90 Novo Nordisk Investigational Site Glasgow United Kingdom G31 2ER
91 Novo Nordisk Investigational Site Inverness United Kingdom IV2 3JH
92 Novo Nordisk Investigational Site Southampton United Kingdom SO16 5YA
93 Novo Nordisk Investigational Site Stevenage United Kingdom SG1 4AB

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01892319
Other Study ID Numbers:
  • NN304-4016
  • U1111-1132-9442
  • ENCEPP/SDPP/4137
First Posted:
Jul 4, 2013
Last Update Posted:
Nov 19, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Insulin Detemir
Hypoglycemic Agents

Study Results

No Results Posted as of Nov 19, 2019