AzTrials
AzTrials

DiabetesPhase 4NCT00365170

Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes

A Phase 4 study testing human insulin and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 95 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 1
What is being tested?
human insulin and insulin aspart
How many people
419 participants
Where
95 sitesin 18 countries
Study dates
Sep 2002to Apr 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

95 sites in 18 countries.

95 sites in 18 countries

United Kingdom27 sites

  • Novo Nordisk Investigational Site

    Ashington, NE63 9JJ

  • Novo Nordisk Investigational Site

    Bath, BA1 3NG

  • Novo Nordisk Investigational Site

    Belfast, BT12 6BA

  • Novo Nordisk Investigational Site

    Birmingham, B9 5SS

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Cambridge, CB2 2QQ

  • Novo Nordisk Investigational Site

    Edgbaston, Birmingham, B15 2TH

  • Novo Nordisk Investigational Site

    Edinburgh, EH16 4SA

  • Novo Nordisk Investigational Site

    Exeter, EX2 5AX

  • Novo Nordisk Investigational Site

    Hull, HU3 2JZ

  • Novo Nordisk Investigational Site

    Leeds, LS9 7TF

  • Novo Nordisk Investigational Site

    Leicester, LE1 5WW

  • Novo Nordisk Investigational Site

    Liverpool, L7 8XP

  • Novo Nordisk Investigational Site

    London, SE5 9RS

  • Novo Nordisk Investigational Site

    London, W12 OHS

  • Novo Nordisk Investigational Site

    Newcastle, NE29 0LR

  • Novo Nordisk Investigational Site

    Norfolk, NR4 7UY

  • Novo Nordisk Investigational Site

    Northampton, NN1 5BD

  • Novo Nordisk Investigational Site

    Nottingham, NG7 2UH

  • Novo Nordisk Investigational Site

    Oxford, OX3 9DU

  • Novo Nordisk Investigational Site

    Plymouth, PL8 8DQ

  • Novo Nordisk Investigational Site

    Reading, RG51 5BS

  • Novo Nordisk Investigational Site

    Sheffield, S10 2JF

  • Novo Nordisk Investigational Site

    Sheffield, S5 7AU

  • Novo Nordisk Investigational Site

    Southampton, SO16 6YD

  • Novo Nordisk Investigational Site

    Stourbridge, DY3 3BG

  • Novo Nordisk Investigational Site

    Worcester, WR5 1HN

Other trials in United Kingdom

France14 sites

  • Novo Nordisk Investigational Site

    Angers, 49033

  • Novo Nordisk Investigational Site

    Avignon, 84902

  • Novo Nordisk Investigational Site

    Bondy, 93143

  • Novo Nordisk Investigational Site

    Brest, 29609

  • Novo Nordisk Investigational Site

    Lille, 59037

  • Novo Nordisk Investigational Site

    Marseille Cédex 05, 13385

  • Novo Nordisk Investigational Site

    Nantes, 44093

  • Novo Nordisk Investigational Site

    Nîmes, 30006

  • Novo Nordisk Investigational Site

    Paris, 75181

  • Novo Nordisk Investigational Site

    Puyricard, 13540

  • Novo Nordisk Investigational Site

    Strasbourg, 67000

  • Novo Nordisk Investigational Site

    Strasbourg, 67091

  • Novo Nordisk Investigational Site

    Toulouse, 31054

  • Novo Nordisk Investigational Site

    Valenciennes, 59322

Other trials in France

Poland8 sites

  • Novo Nordisk Investigational Site

    Krakow, 31-501

  • Novo Nordisk Investigational Site

    Lodz, 93-338

  • Novo Nordisk Investigational Site

    Lublin, 20-081

  • Novo Nordisk Investigational Site

    Olsztyn, 10-457

  • Novo Nordisk Investigational Site

    Poznan, 60-535

  • Novo Nordisk Investigational Site

    Szczecin, 71-455

  • Novo Nordisk Investigational Site

    Warsaw, 02-097

  • Novo Nordisk Investigational Site

    Wroclaw, 50-306

Other trials in Poland

Canada7 sites

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Novo Nordisk Investigational Site

    Ottawa, K1H 8L6

  • Novo Nordisk Investigational Site

    St. John's, A1B 3V6

  • Novo Nordisk Investigational Site

    Toronto, M5G 1X5

  • Novo Nordisk Investigational Site

    Toronto, M5S 1B2

  • Novo Nordisk Investigational Site

    Vancouver, V5Z 1C6

  • Novo Nordisk Investigational Site

    Winnipeg, R3C 0N2

Other trials in Canada

Netherlands7 sites

  • Novo Nordisk Investigational Site

    Apeldoorn, 7334 DZ

  • Novo Nordisk Investigational Site

    Brunssum, 6442 BE

  • Novo Nordisk Investigational Site

    Eindhoven, 5631 BM

  • Novo Nordisk Investigational Site

    Roermond, 6043 CV

  • Novo Nordisk Investigational Site

    Rotterdam, 3045 PM

  • Novo Nordisk Investigational Site

    The Hague, 2597 AX

  • Novo Nordisk Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Austria4 sites

  • Novo Nordisk Investigational Site

    Graz, 8036

  • Novo Nordisk Investigational Site

    Salzburg, 5020

  • Novo Nordisk Investigational Site

    Vienna, 1090

  • Novo Nordisk Investigational Site

    Vienna, A-1130

Other trials in Austria

Israel4 sites

  • Novo Nordisk Investigational Site

    Beersheba, 84101

  • Novo Nordisk Investigational Site

    Haifa, 31096

  • Novo Nordisk Investigational Site

    Jerusalem, 91031

  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

Other trials in Israel

Spain4 sites

  • Novo Nordisk Investigational Site

    Alicante, 03010

  • Novo Nordisk Investigational Site

    Girona, 17007

  • Novo Nordisk Investigational Site

    Santander, 39008

  • Novo Nordisk Investigational Site

    Seville, 41014

Other trials in Spain

Finland3 sites

  • Novo Nordisk Investigational Site

    Helsinki, 00029

  • Novo Nordisk Investigational Site

    Kuopio, 70210

  • Novo Nordisk Investigational Site

    Oulu, 90029

Other trials in Finland

Greece3 sites

  • Novo Nordisk Investigational Site

    Athens, 11521

  • Novo Nordisk Investigational Site

    Athens, 151 23

  • Novo Nordisk Investigational Site

    Athens, GR-11528

Other trials in Greece

Norway3 sites

  • Novo Nordisk Investigational Site

    Oslo, 0027

  • Novo Nordisk Investigational Site

    Tromsø, 9038

  • Novo Nordisk Investigational Site

    Trondheim, NO-7030

Other trials in Norway

Russia3 sites

  • Novo Nordisk Investigational Site

    Moscow, 101000

  • Novo Nordisk Investigational Site

    Moscow, 127411

  • Novo Nordisk Investigational Site

    Saint Petersburg, 199034

Other trials in Russia

Argentina2 sites

  • Novo Nordisk Investigational Site

    Ciudad de Buenos Aires, 1405

  • Novo Nordisk Investigational Site

    Pcia de Cordoba, 5000

Other trials in Argentina

Denmark2 sites

  • Novo Nordisk Investigational Site

    Hvidovre, 2650

  • Novo Nordisk Investigational Site

    København Ø, 2100

Other trials in Denmark

Bulgaria1 site

  • Novo Nordisk Investigational Site

    Sofia, 1431

Other trials in Bulgaria

Croatia1 site

  • Novo Nordisk Investigational Site

    Zagreb, 10 000

Other trials in Croatia

Germany1 site

  • Novo Nordisk Investigational Site

    Berlin, 12051

Other trials in Germany

Ireland1 site

  • Novo Nordisk Investigational Site

    Dublin, DUBLIN 7

Other trials in Ireland

About this study

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.

Being tested
human insulin, insulin aspart
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human insulinDrug

  • insulin aspartDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative risk of major maternal hypoglycaemia

    Measured: after 24 hours

Secondary outcomes (4)

  1. Relative risk of major and minor hypoglycaemia

  2. Diabetic complications

  3. Obstetric complications

  4. Other Adverse Events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2006 (estimated)
  2. Study startSep 2002
  3. Primary completionApr 2005
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00365170
Sponsor's protocol ID
ANA-1474
Status last verified
Dec 2016
First submitted
10 Aug 2006
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17392539

  • 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.

    PubMed 17596485

  • 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.

    PubMed 17905178

  • 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.

    PubMed 18726086

  • 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.

    PubMed 20007944

  • 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.

    PubMed 23687948

  • 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.

    PubMed 17392542

  • 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.

    PubMed 17392541

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing human insulin and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 95 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United Kingdom, France, Poland, Canada, Netherlands and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative risk of major maternal hypoglycaemia (time frame: after 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00365170, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in