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

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ClinicalTrials.gov Identifier: NCT03377699
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The investigators are doing this study to see the effect of insulin degludec in pregnant women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin degludec is compared to another medicine called insulin detemir. Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance. Participants will get pre-filled insulin pens. Participants will need to take blood sugar measurements several times a day. The study will last between 10 and 25 months depending on whether participants are already pregnant when they join the study. The number of visits and the tests ( for example blood and urine samples and ultrasound scans) the participants will have also depends on whether they are pregnant at study start.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Insulin degludec Drug: Insulin Aspart Drug: Insulin detemir Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Insulin Degludec
Insulin Degludec once daily and Insulin Aspart 2-4 times daily
Drug: Insulin degludec
Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months

Drug: Insulin Aspart
Injection for subcutaneous (s.c., under the skin) use 2-4 times daily with meals. The total trial duration for subjects will be maximum 25 months

Active Comparator: Insulin Determir
Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily
Drug: Insulin Aspart
Injection for subcutaneous (s.c., under the skin) use 2-4 times daily with meals. The total trial duration for subjects will be maximum 25 months

Drug: Insulin detemir
Injection for subcutaneous (s.c., under the skin) use, once daily or twice daily. The total trial duration for subjects will be maximum 25 months




Primary Outcome Measures :
  1. Last planned glycosylated haemoglobin (HbA1c) prior to delivery [ Time Frame: After gestational week 16 to last planned measurement at gestational week 36 plus 7 days ]
    Measured in %


Secondary Outcome Measures :
  1. HbA1c below or equal to 6.0% (42 mmol/mol) from last planned HbA1c prior to delivery (yes/no) [ Time Frame: After gestational week 16 to last planned measurement prior to delivery ]
    Proportion of subjects

  2. Last planned average post-prandial glucose prior to delivery. Average of three main meals. [ Time Frame: After gestational week 16 to last planned measurement prior to delivery ]
    Measured in mg/dl or other equivalent SI units

  3. Last planned fasting plasma glucose prior to delivery [ Time Frame: After gestational week 16 to last planned measurement prior to delivery ]
    Measured in mg/dl or other equivalent SI units

  4. Number of hypoglycaemic episodes [ Time Frame: During the pregnancy period (from first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery) ]
    Count of episodes

  5. Development of sight-threatening retinopathy defined as proliferative retinopathy or maculopathy (yes/no) [ Time Frame: From treatment baseline (visit 2, week0), to end of treatment visit after delivery (up to 28 days after delivery) ]
    Proportion of subjects with events

  6. Number of adverse events [ Time Frame: During the pregnancy period (from first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery) ]
    Count and % of Adverse events

  7. 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: Occurring from gestational week 20 to delivery ]
    Number of combined events

  8. Birth weight (kg) [ Time Frame: At birth ]
    Measured in kg

  9. Pre-term delivery (delivery before 37 completed gestational weeks) (yes/no) [ Time Frame: At birth ]
    Number of events

  10. Presence of major abnormalities (classified according to EUROCAT) (yes/no) [ Time Frame: At birth ]
    Number of children with abnormalities

  11. Live born infants (yes/no) [ Time Frame: At birth ]
    Number of children

  12. Number of adverse events in the infant [ Time Frame: From delivery to final follow-up 30 days after delivery ]
    Count and % of Adverse events

  13. 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 the first 24 hours after birth ]
    Number of events

  14. HbA1c below or equal to 6.5% (48 mmol/mol) from last planned HbA1c prior to delivery (yes/no) [ Time Frame: After gestational week 16 to last planned ]
    Proportion of subjects

  15. Mode of delivery, e.g. vaginal, operative vaginal, planned caesarean section or unplanned caesarean section, induced or spontaneous delivery [ Time Frame: At birth ]
    Number of type of delivery

  16. Change in body weight [ Time Frame: From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth) ]
    Measured in kg and/or %

  17. Early foetal death (delivery before 20 completed GWs) (yes/no) [ Time Frame: At birth ]
    Number of events

  18. Perinatal mortality (death of foetus/infant ) (yes/no) [ Time Frame: Between at least 20 completed GWs before delivery and before 7completed days after delivery ]
    Number of children

  19. Neonatal mortality (death of infant) (yes/no) [ Time Frame: Between at least 7 completed days after delivery and before 28 completed days after delivery ]
    Number of children

  20. Development of sight-threatening retinopathy defined as proliferative retinopathy or maculopathy (yes/no) [ Time Frame: From pregnancy baseline (corresponding to gestational week 8-13) to end of treatment visit after delivery (up to 28 days after delivery) ]
    Number of events

  21. 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 events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377699


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03377699     History of Changes
Other Study ID Numbers: NN1250-4300
U1111-1191-3018 ( Registry Identifier: World Health organization (WHO) )
2017-000048-17 ( Registry Identifier: EudraCT )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin Detemir
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs