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 enrolled 233 people in the insulin detemir group and 237 in the NPH insulin group — a total of 470 participants. All participants were women with type 1 diabetes who were either planning a pregnancy or became pregnant during the study. The trial was primarily measuring a blood sugar marker called HbA1c (glycosylated haemoglobin) — a percentage figure that reflects average blood sugar levels over roughly the previous two to three months — at week 36 of pregnancy. The reported data shows that at week 36 of pregnancy, the average HbA1c was 6.27% in the insulin detemir group and 6.33% in the NPH insulin group (under the "full analysis" approach), and 6.22% versus 6.37% respectively under a stricter "per protocol" analysis (which looked only at participants who followed the study plan most closely). For a secondary measure looking at how many participants reached an HbA1c at or below 6.0% at both week 24 and week 36 of pregnancy, the reported data shows 57 participants in the insulin detemir group and 46 in the NPH insulin group met that threshold. Fasting blood glucose levels (measured in mmol/L, a standard unit for sugar in the blood) were also tracked at several points during the study and are included in the reported data, with readings across different time points ranging from 4.7 to 5.2 mmol/L for insulin detemir and 5.4 to 6.3 mmol/L for NPH insulin. Self-monitored blood sugar readings taken at eight set times during the day were also recorded at week 24, with values across the eight time points ranging from 6.1 to 7.7 mmol/L for insulin detemir and 6.7 to 8.0 mmol/L for NPH insulin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
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
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 have Type 1 diabetes and have been taking insulin for at least 12 months
- You are planning to become pregnant and your recent blood sugar control test (HbA1c) shows a result of 9.0% or lower, OR
- You are already pregnant with one baby, between 8 and 12 weeks along, and your HbA1c was 8.0% or lower when your pregnancy was confirmed
Who may not be able to join:
- You have a known or suspected allergy to the study medicine or similar medicines
- You have an untreated thyroid condition (either overactive or underactive thyroid)
- You have a known or suspected problem with alcohol or drug misuse
- You have heart problems
- Your kidneys are not working properly
- You have previously had severe, uncontrollable nausea and vomiting during a past pregnancy (a condition called hyperemesis gravidarum)
- You became pregnant through IVF or other medical fertility treatments
- Your liver is not working properly
- You have high blood pressure that is not well controlled
- You have a serious eye condition related to diabetes that needs urgent treatment
- You have tested positive for HIV, Hepatitis B, or Hepatitis C
- You are taking any other medication that is not considered safe to use during pregnancy
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.
Contact this trial
Principal Investigator: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Australian sites
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
Where this trial is recruiting
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36; Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.