Phase 3 Type 1 Diabetes Trial, Completed NCT03377699 Sponsor: Novo Nordisk A/S Condition: Type 1 Diabetes
Back to Type 1 Diabetes

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03377699) enrolled 111 people in the insulin degludec group (called IDeg) and 114 in the insulin detemir group (called IDet) — a total of 225 pregnant women with type 1 diabetes. The trial compared two types of long-acting insulin to see how well each kept blood sugar levels controlled during pregnancy. The main thing being measured was a blood test called HbA1c (a measure of average blood sugar over several weeks) taken at the last scheduled check-up before giving birth. By the end of the study, 89 participants in each group had completed the trial. The reported data shows that average HbA1c levels just before delivery were very similar between the two groups. In the IDeg group the average was around 6.30–6.32%, and in the IDet group it was around 6.26%, depending on the observation period used. For a secondary measure looking at how many participants reached an HbA1c of 6.5% or below before delivery, the reported data shows 58 people in the IDeg group and 53 in the IDet group reached that level (with 26 and 31 respectively not reaching it). For the stricter target of 6.0% or below, 36 people in the IDeg group and 31 in the IDet group reached that level. The reported data also shows average blood sugar 90 minutes after meals was 7.37 mmol/L for IDeg and 6.96 mmol/L for IDet, while fasting blood sugar was 6.17 mmol/L for IDeg and 6.79 mmol/L for IDet. During the pregnancy period, the number of recorded low blood sugar episodes (hypoglycaemia) was 5,431 in the IDeg group and 5,982 in the IDet group across all participants in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Type 1 Diabetes Trial, Completed

NCT03377699
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a woman aged 18 or older at the time of signing the consent form
  • You have been diagnosed with type 1 diabetes for at least 1 year before your screening appointment
  • You have been using daily insulin injections, an insulin pump, or inhaled insulin for at least 90 days before your screening appointment
  • You are either planning to become pregnant within 12 months of joining the trial and are willing to attend pre-pregnancy counselling, OR you are already pregnant (between 8 and 13 weeks and 6 days) with a single baby showing no observed problems, confirmed by ultrasound
  • Your blood sugar control (HbA1c) measured at screening is at or below 8.0%, as confirmed by a central lab

Who may not be able to join:

  • You have taken any medication for diabetes or obesity in the past 90 days other than the insulin types mentioned above
  • You are pregnant and have a high level of protein in your urine, as measured at screening
  • You became pregnant or are pregnant through IVF or other assisted fertility treatments
  • You have taken any medication considered unsafe in pregnancy within 28 days before screening (confirm with trial site for exact timing details)
  • You have a serious eye condition related to diabetes in the back of your eye that needs urgent treatment, confirmed by an eye examination within a recent period before joining
  • You have a history of severe morning sickness during a previous pregnancy that required a hospital stay

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Novo Nordisk Investigational Site, Blacktown, New South Wales
Novo Nordisk Investigational Site, Campbelltown, New South Wales
Novo Nordisk Investigational Site, St Leonards, New South Wales
Novo Nordisk Investigational Site, Ipswich, Queensland
Novo Nordisk Investigational Site, Elizabeth Vale, South Australia
Novo Nordisk Investigational Site, Box Hill, Victoria
Novo Nordisk Investigational Site, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
22 November 2017
Est. completion
17 December 2020

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇷 Brazil 🇨🇦 Canada 🇭🇷 Croatia 🇩🇰 Denmark 🇬🇷 Greece 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇷🇺 Russia 🇷🇸 Serbia 🇪🇸 Spain 🇬🇧 United Kingdom

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov