Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 30 January 2023
• Main ID: NCT03377699
• Date of registration: 16/11/2017
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes EXPECT
• Scientific title: A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes
• Date of first enrolment: November 22, 2017
• Target sample size: 225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03377699
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, Croatia, Denmark, Greece, Ireland, Israel, Italy, Russian Federation, Serbia, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria: - Female, age at least 18 years at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus for at least 1 year prior to the day of screening
- Treated with multiple daily subcutaneous insulin injections or continuous subcutaneous
insulin infusion (CSII) or inhaled insulin for at least 90 days prior to the day of
screening - The subject is planning to become pregnant within 12 months from randomisation
and willing to undertake pre-pregnancy counselling or the subject is pregnant with an
intrauterine singleton living foetus (gestational week 8 to 13 (+6 days)) without any
observed anomalies at randomisation, confirmed by an ultrasound scan - HbA1c at screening
below or equal to 8.0% (64 mmol/mol) by central laboratory Exclusion Criteria: - Treatment
with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria within the past 90 days prior to the day of screening - Pregnant and
having proteinuria as evaluated by urine protein-to-creatinine ratio above or equal to 300
mg/g in urine sample measured at screening - Subject being treated or became pregnant with
assistance of in vitro fertilisation or other medical infertility treatment - Receipt of
any concomitant medication contraindicated in pregnancy according to local label within 28
days before screening and between screening and randomisation for non-pregnant subjects and
28 days before conception and between conception and randomisation for pregnant subjects -
Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or pharmacologically dilated fundoscopy performed within the past 90 days prior
to randomisation for non-pregnant subjects or within 28 days prior to randomisation for
pregnant subjects. - History of severe hyperemesis gravidarum (requiring hospitalisation)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Diabetes

Intervention(s)

Drug: Insulin degludec

Drug: Insulin detemir

Drug: Insulin Aspart

Primary Outcome(s)

Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery [Time Frame: From GW 16 to GW 36]

Secondary Outcome(s)

Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery [Time Frame: From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)]

Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no) [Time Frame: During between 24 and 48 hours after birth]

Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no) [Time Frame: From GW 20 to delivery]

Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals) [Time Frame: From GW 16 to GW 36]

Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no] [Time Frame: At birth]

Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no) [Time Frame: From treatment baseline (week 0) to end of treatment (28 days after delivery)]

Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no) [Time Frame: Between at least 7 completed days after delivery and before 28 completed days after delivery]

Birth Weight for Live Birth Infants [Time Frame: At birth]

Birth Weight Standard Deviation (SD) Score for Live Birth Infants [Time Frame: At birth]

Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no) [Time Frame: Between at least 20 completed GWs before delivery and before 7 completed days after delivery]

Number of Hypoglycaemic Episodes During the Pregnancy Period [Time Frame: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)]

Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no) [Time Frame: From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)]

Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants [Time Frame: At birth]

Number of Participants With Pre-term Delivery [Time Frame: At birth]

Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no) [Time Frame: At birth]

Number of Adverse Events During Pregnancy Period [Time Frame: From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)]

Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery [Time Frame: At birth]

Number of Participants With Live Born Infants (Yes/no) [Time Frame: At birth]

Number of Adverse Events in the Infant [Time Frame: From delivery to final follow-up 30 days after delivery]

Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no) [Time Frame: From GW 16 to GW 36]

Last Planned Fasting Plasma Glucose Prior to Delivery [Time Frame: From GW 16 to GW 36]

Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no) [Time Frame: At birth]

Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no) [Time Frame: From GW 16 to GW 36]

Secondary ID(s)

NN1250-4300

2017-000048-17

U1111-1191-3018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03377699