Diabetes Clinical Trial
Official title:
A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
This trial was conducted in Europe, Middle East, North America and South America.
The aim of this trial was to compare the use of an intensified insulin treatment with
insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.
| Status | Completed |
| Enrollment | 419 |
| Est. completion date | April 2005 |
| Est. primary completion date | April 2005 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 1 diabetes - Treated with insulin for at least 12 months - Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or - Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan. Exclusion Criteria: - Previous birth of child with a major congenital malformation - More than 2 previous multiple miscarriages or stillbirths - Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement - Subjects being treated for infertility - Proliferative retinopathy or maculopathy requiring acute treatment - Drug or alcohol abuse - Impaired renal, hepatic or cardiac function |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Ciudad de Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Pcia de Cordoba | |
| Austria | Novo Nordisk Investigational Site | Graz | |
| Austria | Novo Nordisk Investigational Site | Salzburg | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Bulgaria | Novo Nordisk Investigational Site | Sofia | |
| Canada | Novo Nordisk Investigational Site | Halifax | Nova Scotia |
| Canada | Novo Nordisk Investigational Site | Ottawa | |
| Canada | Novo Nordisk Investigational Site | St John's | |
| Canada | Novo Nordisk Investigational Site | Toronto | |
| Canada | Novo Nordisk Investigational Site | Toronto | |
| Canada | Novo Nordisk Investigational Site | Vancouver | |
| Canada | Novo Nordisk Investigational Site | Winnipeg | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Denmark | Novo Nordisk Investigational Site | Hvidovre | |
| Denmark | Novo Nordisk Investigational Site | København ø | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kuopio | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| France | Novo Nordisk Investigational Site | ANGERS cedex 09 | |
| France | Novo Nordisk Investigational Site | Avignon | |
| France | Novo Nordisk Investigational Site | Bondy | |
| France | Novo Nordisk Investigational Site | Brest | |
| France | Novo Nordisk Investigational Site | Lille | |
| France | Novo Nordisk Investigational Site | MARSEILLE Cédex 05 | |
| France | Novo Nordisk Investigational Site | Nantes | |
| France | Novo Nordisk Investigational Site | Nimes | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | PuyRicard | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| France | Novo Nordisk Investigational Site | Valenciennes | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Israel | Novo Nordisk Investigational Site | Beer Sheva | |
| Israel | Novo Nordisk Investigational Site | Haifa | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Israel | Novo Nordisk Investigational Site | Petah-Tikva | |
| Netherlands | Novo Nordisk Investigational Site | Apeldoorn | |
| Netherlands | Novo Nordisk Investigational Site | Brunssum | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Eindhoven | |
| Netherlands | Novo Nordisk Investigational Site | Roermond | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Utrecht | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Tromsø | |
| Norway | Novo Nordisk Investigational Site | Trondheim | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Lodz | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Olsztyn | |
| Poland | Novo Nordisk Investigational Site | Poznan | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Poland | Novo Nordisk Investigational Site | Wroclaw | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Spain | Novo Nordisk Investigational Site | Alicante | |
| Spain | Novo Nordisk Investigational Site | Girona | |
| Spain | Novo Nordisk Investigational Site | Santander | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| United Kingdom | Novo Nordisk Investigational Site | Ashington | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Belfast | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Cambridge | |
| United Kingdom | Novo Nordisk Investigational Site | Edgbaston, Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Edinburgh | |
| United Kingdom | Novo Nordisk Investigational Site | Exeter | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Leeds | |
| United Kingdom | Novo Nordisk Investigational Site | Leicester | |
| United Kingdom | Novo Nordisk Investigational Site | Liverpool | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Newcastle | |
| United Kingdom | Novo Nordisk Investigational Site | Norfolk | |
| United Kingdom | Novo Nordisk Investigational Site | Northampton | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Oxford | |
| United Kingdom | Novo Nordisk Investigational Site | Plymouth | |
| United Kingdom | Novo Nordisk Investigational Site | Reading | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Southampton | |
| United Kingdom | Novo Nordisk Investigational Site | Stourbridge | |
| United Kingdom | Novo Nordisk Investigational Site | Worcester |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Argentina, Austria, Bulgaria, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Netherlands, Norway, Poland, Russian Federation, Spain, United Kingdom,
Damm P, Mersebach H, Råstam J, Kaaja R, Hod M, McCance DR, Mathiesen ER. Poor pregnancy outcome in women with type 1 diabetes is predicted by elevated HbA1c and spikes of high glucose values in the third trimester. J Matern Fetal Neonatal Med. 2014 Jan;27 — View Citation
Heller S, Damm P, Mersebach H, Skjøth TV, Kaaja R, Hod M, Durán-García S, McCance D, Mathiesen ER. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study. Diabetes Care. 2010 Mar;33(3):473-7. doi: 1 — View Citation
Hod M, Damm P, Kaaja R, Visser GH, Dunne F, Demidova I, Hansen AS, Mersebach H; Insulin Aspart Pregnancy Study Group.. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subject — View Citation
Hod M, Jovanovic L. Improving outcomes in pregnant women with type 1 diabetes. Diabetes Care. 2007 Jul;30(7):e62. — View Citation
Mathiesen ER, Kinsley B, Amiel SA, Heller S, McCance D, Duran S, Bellaire S, Raben A; Insulin Aspart Pregnancy Study Group.. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin — View Citation
McCance DR, Damm P, Mathiesen ER, Hod M, Kaaja R, Dunne F, Jensen LE, Mersebach H. Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus. Diabetologia. 2008 Nov;51(11):2141-3. doi: 10.100 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative risk of major maternal hypoglycaemia | after 24 hours | No | |
| Secondary | Relative risk of major and minor hypoglycaemia | No | ||
| Secondary | Diabetic complications | No | ||
| Secondary | Obstetric complications | No | ||
| Secondary | Other Adverse Events | No |
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|---|---|---|---|
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