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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03377699




Registration number
NCT03377699
Ethics application status
Date submitted
16/11/2017
Date registered
19/12/2017
Date last updated
13/07/2020

Titles & IDs
Public title
Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
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
Secondary ID [1] 0 0
U1111-1191-3018
Secondary ID [2] 0 0
NN1250-4300
Universal Trial Number (UTN)
Trial acronym
EXPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin degludec
Treatment: Drugs - Insulin Aspart
Treatment: Drugs - Insulin detemir

Experimental: Insulin Degludec - Insulin Degludec once daily and Insulin Aspart 2-4 times daily

Active Comparator: Insulin Determir - Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily


Treatment: Drugs: Insulin degludec
Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months

Treatment: Drugs: 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

Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Last planned glycosylated haemoglobin (HbA1c) prior to delivery - Measured in %
Timepoint [1] 0 0
After gestational week 16 to last planned measurement at gestational week 36 plus 7 days
Secondary outcome [1] 0 0
HbA1c below or equal to 6.0% (42 mmol/mol) from last planned HbA1c prior to delivery (yes/no) - Proportion of subjects
Timepoint [1] 0 0
After gestational week 16 to last planned measurement prior to delivery
Secondary outcome [2] 0 0
Last planned average post-prandial glucose prior to delivery. Average of three main meals. - Measured in mg/dl or other equivalent SI units
Timepoint [2] 0 0
After gestational week 16 to last planned measurement prior to delivery
Secondary outcome [3] 0 0
Last planned fasting plasma glucose prior to delivery - Measured in mg/dl or other equivalent SI units
Timepoint [3] 0 0
After gestational week 16 to last planned measurement prior to delivery
Secondary outcome [4] 0 0
Number of hypoglycaemic episodes - Count of episodes
Timepoint [4] 0 0
During the pregnancy period (from first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery)
Secondary outcome [5] 0 0
Development of sight-threatening retinopathy defined as proliferative retinopathy or maculopathy (yes/no) - Proportion of subjects with events
Timepoint [5] 0 0
From treatment baseline (visit 2, week0), to end of treatment visit after delivery (up to 28 days after delivery)
Secondary outcome [6] 0 0
Number of adverse events - Count and % of Adverse events
Timepoint [6] 0 0
During the pregnancy period (from first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery)
Secondary outcome [7] 0 0
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) - Number of combined events
Timepoint [7] 0 0
Occurring from gestational week 20 to delivery
Secondary outcome [8] 0 0
Birth weight (kg) - Measured in kg
Timepoint [8] 0 0
At birth
Secondary outcome [9] 0 0
Pre-term delivery (delivery before 37 completed gestational weeks) (yes/no) - Number of events
Timepoint [9] 0 0
At birth
Secondary outcome [10] 0 0
Presence of major abnormalities (classified according to EUROCAT) (yes/no) - Number of children with abnormalities
Timepoint [10] 0 0
At birth
Secondary outcome [11] 0 0
Live born infants (yes/no) - Number of children
Timepoint [11] 0 0
At birth
Secondary outcome [12] 0 0
Number of adverse events in the infant - Count and % of Adverse events
Timepoint [12] 0 0
From delivery to final follow-up 30 days after delivery
Secondary outcome [13] 0 0
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) - Number of events
Timepoint [13] 0 0
During the first 24 hours after birth
Secondary outcome [14] 0 0
HbA1c below or equal to 6.5% (48 mmol/mol) from last planned HbA1c prior to delivery (yes/no) - Proportion of subjects
Timepoint [14] 0 0
After gestational week 16 to last planned
Secondary outcome [15] 0 0
Mode of delivery, e.g. vaginal, operative vaginal, planned caesarean section or unplanned caesarean section, induced or spontaneous delivery - Number of type of delivery
Timepoint [15] 0 0
At birth
Secondary outcome [16] 0 0
Change in body weight - Measured in kg and/or %
Timepoint [16] 0 0
From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)
Secondary outcome [17] 0 0
Early foetal death (delivery before 20 completed GWs) (yes/no) - Number of events
Timepoint [17] 0 0
At birth
Secondary outcome [18] 0 0
Perinatal mortality (death of foetus/infant ) (yes/no) - Number of children
Timepoint [18] 0 0
Between at least 20 completed GWs before delivery and before 7completed days after delivery
Secondary outcome [19] 0 0
Neonatal mortality (death of infant) (yes/no) - Number of children
Timepoint [19] 0 0
Between at least 7 completed days after delivery and before 28 completed days after delivery
Secondary outcome [20] 0 0
Development of sight-threatening retinopathy defined as proliferative retinopathy or maculopathy (yes/no) - Number of events
Timepoint [20] 0 0
From pregnancy baseline (corresponding to gestational week 8-13) to end of treatment visit after delivery (up to 28 days after delivery)
Secondary outcome [21] 0 0
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) - Number of events
Timepoint [21] 0 0
During between 24 and 48 hours after birth

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Campbelltown
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Elizabeth Vale
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4305 - Ipswich
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Caba
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Mendoza
Country [4] 0 0
Argentina
State/province [4] 0 0
Salta
Country [5] 0 0
Austria
State/province [5] 0 0
Graz
Country [6] 0 0
Austria
State/province [6] 0 0
Innsbruck
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Brazil
State/province [8] 0 0
Goias
Country [9] 0 0
Brazil
State/province [9] 0 0
Parana
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio Grande Do Sul
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
Ribeirao Preto
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
St John's
Country [19] 0 0
Croatia
State/province [19] 0 0
Zagreb
Country [20] 0 0
Denmark
State/province [20] 0 0
Aarhus N
Country [21] 0 0
Denmark
State/province [21] 0 0
København ø
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Greece
State/province [23] 0 0
Larissa
Country [24] 0 0
Greece
State/province [24] 0 0
Nea Efkarpia - Thessaloniki
Country [25] 0 0
Ireland
State/province [25] 0 0
Dublin 2
Country [26] 0 0
Ireland
State/province [26] 0 0
Dublin
Country [27] 0 0
Ireland
State/province [27] 0 0
Galway
Country [28] 0 0
Israel
State/province [28] 0 0
Petach Tikva
Country [29] 0 0
Israel
State/province [29] 0 0
Rehovot
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Padova
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Sant'Andrea Delle Fratte (PG)
Country [34] 0 0
Italy
State/province [34] 0 0
Torino
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Ekaterinburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Kirov
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Saint-Petersburg
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Saratov
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Tomsk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Ulianovsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Yoshkar-Ola
Country [43] 0 0
Serbia
State/province [43] 0 0
Belgrade
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Bath
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Cambridge
Country [47] 0 0
United Kingdom
State/province [47] 0 0
High Wycombe
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Leeds
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Middlesbrough
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Norwich
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Nottingham
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Oxford
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03377699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications