Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes
NCT ID: NCT00365170
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
419 participants
INTERVENTIONAL
2002-09-30
2005-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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human insulin
insulin aspart
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (1452, GCR)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Ciudad de Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Pcia de Cordoba, , Argentina
Novo Nordisk Investigational Site
Graz, , Austria
Novo Nordisk Investigational Site
Salzburg, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
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, , Canada
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Hvidovre, , Denmark
Novo Nordisk Investigational Site
København Ø, , Denmark
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Kuopio, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Angers, , 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
Nîmes, , 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, , France
Novo Nordisk Investigational Site
Valenciennes, , France
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Dublin, , Ireland
Novo Nordisk Investigational Site
Beersheba, , Israel
Novo Nordisk Investigational Site
Haifa, , Israel
Novo Nordisk Investigational Site
Jerusalem, , Israel
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Apeldoorn, , Netherlands
Novo Nordisk Investigational Site
Brunssum, , Netherlands
Novo Nordisk Investigational Site
Eindhoven, , Netherlands
Novo Nordisk Investigational Site
Roermond, , Netherlands
Novo Nordisk Investigational Site
Rotterdam, , Netherlands
Novo Nordisk Investigational Site
The Hague, , Netherlands
Novo Nordisk Investigational Site
Utrecht, , Netherlands
Novo Nordisk Investigational Site
Oslo, , Norway
Novo Nordisk Investigational Site
Tromsø, , Norway
Novo Nordisk Investigational Site
Trondheim, , Norway
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
Warsaw, , Poland
Novo Nordisk Investigational Site
Wroclaw, , Poland
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Alicante, , Spain
Novo Nordisk Investigational Site
Girona, , Spain
Novo Nordisk Investigational Site
Santander, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
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, , United Kingdom
Countries
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References
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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 in 322 pregnant women. Diabetes Care. 2007 Apr;30(4):771-6. doi: 10.2337/dc06-1887.
Hod M, Jovanovic L. Improving outcomes in pregnant women with type 1 diabetes. Diabetes Care. 2007 Jul;30(7):e62. doi: 10.2337/dc07-0488. No abstract available.
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 subjects. Am J Obstet Gynecol. 2008 Feb;198(2):186.e1-7. doi: 10.1016/j.ajog.2007.08.005. Epub 2007 Oct 1.
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: 10.1007/s00125-008-1120-y. Epub 2008 Aug 23. No abstract available.
Heller S, Damm P, Mersebach H, Skjoth TV, Kaaja R, Hod M, Duran-Garcia 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: 10.2337/dc09-1605. Epub 2009 Dec 10.
Damm P, Mersebach H, Rastam 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(2):149-54. doi: 10.3109/14767058.2013.806896. Epub 2013 Jun 20.
Altschuler JA, Casella SJ, MacKenzie TA, Curtis KM. The effect of cinnamon on A1C among adolescents with type 1 diabetes. Diabetes Care. 2007 Apr;30(4):813-6. doi: 10.2337/dc06-1871.
Williams MM, Clouse RE, Nix BD, Rubin EH, Sayuk GS, McGill JB, Gelenberg AJ, Ciechanowski PS, Hirsch IB, Lustman PJ. Efficacy of sertraline in prevention of depression recurrence in older versus younger adults with diabetes. Diabetes Care. 2007 Apr;30(4):801-6. doi: 10.2337/dc06-1825.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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ANA-1474
Identifier Type: -
Identifier Source: org_study_id