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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03377699
Collaborator
(none)
225
71
2
36.8
3.2
0.1

Study Details

Study Description

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
  • Drug: Insulin degludec
  • Drug: Insulin Aspart
  • Drug: Insulin detemir
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
225 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 :
Nov 22, 2017
Actual Primary Completion Date :
Dec 17, 2020
Actual Study Completion Date :
Dec 17, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery [From GW 16 to GW 36]

    Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.

Secondary Outcome Measures

  1. 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) [From GW 16 to GW 36]

    Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

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

    Number of participants who achieved pre-defined HbA1c targets ≤ 6.5% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.5% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.5% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

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

    Mean of post-prandial glucose (PPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. Average PPG is defined as the average of the available blood glucouse (BG) measurements 90 minutes after breakfast, lunch and main evening meal respectively. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

  4. Last Planned Fasting Plasma Glucose Prior to Delivery [From GW 16 to GW 36]

    Mean of fasting plasma glucose (FPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from in-trial observation period. The in-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

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

    Number of treatment emergent hypoglycaemic episodes during the pregnancy period is presented. Hypoglycaemic episode (plasma glucose <= 3.9 mmol/L (70 milligrams per decilitre (mg/dL)) Or > 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs on or after the first day of trial product administration, and no later than 7 days from the last day on trial product. The endpoint was evaluated based on the data from pregnancy period. Pregnancy period started from first day of pregnancy (date of conception corresponding to the first day in GW 2) or randomisation (whichever comes last) to the date of delivery.

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

    Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. Eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between pregnancy baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.

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

    Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. For pregnant women, eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between treatment baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.

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

    Number of adverse events (AEs) during pregnancy period is reported. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs presented are treatment-emergent AEs (TEAEs). The TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

  9. 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) [From GW 20 to delivery]

    Number of participants with one or more events of pre-eclampsia during pregnancy period is reported. Pre-eclampsia was defined as new-onset hypertension (greater than or equal to) ≥ 140 millimeters of mercury (mmHg) systolic or ≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) occurring from GW 20 to delivery and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, or other severe organ involvement. In the reported data, 'Yes' infers number of participants who had pre-eclampsia events whereas 'No' infers number of participants who have not had pre-eclampsia events.

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

    Number of participants who had delivered by which mode of delivery (vaginal, operative vaginal, planned caesarean section or unplanned caesarean section delivery) is presented. Planned caesarean section: decision taken > 8 hours prior to delivery. Unplanned caesarean section: decision taken ≤ 8 hours prior to delivery. In case of 'early foetal death' or if the participant did not fill the pregnancy outcome form then mode of delivery was reported as 'missing'.

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

    Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented.

  12. Birth Weight for Live Birth Infants [At birth]

    Mean birth weight for live birth infants is presented. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

  13. Birth Weight Standard Deviation (SD) Score for Live Birth Infants [At birth]

    Mean of birth weight SD score for live infants is presented. Birth weight SD score indicates how far an infant's score deviates from the mean of the reference population of same age and same sex born at the same gestational week as per local normal curves. The SD score of 0 indicates that the infants born weigh approximately the same, negative score indicates that the infants born weigh lesser and positive score indicates that the infants born weigh more when compared with the reference population. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

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

    Number of live born infants with birth weight <10th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants.In the reported data,'Yes' infers number of live born infants with birth weight <10th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not <10th percentile for gestational age and sex.Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.Endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion,up to 24 months.Date of trial completion:final scheduled follow-up visit (delivery + 58 days).

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

    Number of live born infants with birth weight >90th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants. In the reported data,'Yes' infers number of live born infants with birth weight >90th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not >90th percentile for gestational age and sex.Unaddressed category refers to cases where either parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if THE participants did not fill the pregnancy outcome form.The endpoint was evaluated based on the data from in-trial observation period:started at randomization and ended at the date of trial completion,up to 24 months. Date of trial completion:final scheduled follow-up visit (delivery + 58 days).

  16. Number of Participants With Pre-term Delivery [At birth]

    Number of pregnant women who had pre-term delivery is presented. Pre-term delivery refers to delivery in < 37 completed GWs. In the reported data, 'Yes' infers number of participants who had pre-term delivery whereas 'No' infers number of participants who has not had pre-term delivery. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion,up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery+58 days). For participants who had not attended the follow-up visit,the date of trial completion was the date of the last participant-investigator contact.

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

    Number of participants who had early foetal death (delivery before 20 completed GWs) is presented. In the reported data, 'Yes' infers early foetal deaths whereas 'No' infers no foetal deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

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

    Number of participants who had foetal/infant loss at delivery is presented. Perinatal mortality: death of foetus/infant between ≥ 20 completed GWs before delivery and <1 completed week after delivery). In the reported data, 'Yes' infers early foetal/infant deaths whereas 'No' infers no foetal/infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion, up to 24 months. Date of trial completion: final scheduled follow-up visit (delivery + 58 days).

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

    Number of participants who had infant loss after delivery is presented. Neonatal mortality: death of infant between ≥7 completed days after delivery and < 28 completed days after delivery. In the reported data, 'Yes' infers infant deaths whereas 'No' infers no infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

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

    Number of participants who delivered foetuses/infants with abnormalities (classified according to EUROCAT) is presented. Presence of major abnormalities were based on adjudicated data, as after adjudication congenital anomalies were classified into major or minor anomalies or in other categories. In reported data, 'Yes' infers presence of major abnormalities whereas 'No' infers absence of major abnormalities in foetus/infant. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion up to 24 months. Date of trial completion : final scheduled follow-up visit (delivery + 58 days).

  21. Number of Participants With Live Born Infants (Yes/no) [At birth]

    Number of participants with live born infants is presented. In the reported data, 'Yes' infers number of live infants whereas 'No' infers early foetal death or termination of pregnancy (induced/elective abortion). The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.

  22. Number of Adverse Events in the Infant [From delivery to final follow-up 30 days after delivery]

    AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs in foetus/infant with particular focus on the AEs from delivery to follow-up are presented.

  23. 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) [During between 24 and 48 hours after birth]

    Number of infants with neonatal hypoglycaemic episodes is presented. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or below or equal to 2.5 mmol/L (45 mg/dl) between 24 hours and 48 hours after birth. In the reported data, 'Yes' infers number of infants with neonatal hypoglycaemic episodes whereas 'No' infers number of infants with no neonatal hypoglycaemic episodes. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Caba Argentina C1180AAX
2 Novo Nordisk Investigational Site Caba Argentina C1189AAS
3 Novo Nordisk Investigational Site Caba Argentina C1430CKE
4 Novo Nordisk Investigational Site Córdoba Argentina X5016KEH
5 Novo Nordisk Investigational Site Mendoza Argentina 5500
6 Novo Nordisk Investigational Site Salta Argentina 4400
7 Novo Nordisk Investigational Site Blacktown New South Wales Australia 2148
8 Novo Nordisk Investigational Site Campbelltown New South Wales Australia 2560
9 Novo Nordisk Investigational Site St Leonards New South Wales Australia 2065
10 Novo Nordisk Investigational Site Ipswich Queensland Australia 4305
11 Novo Nordisk Investigational Site Elizabeth Vale South Australia Australia 5112
12 Novo Nordisk Investigational Site Box Hill Victoria Australia 3128
13 Novo Nordisk Investigational Site Parkville Victoria Australia 3052
14 Novo Nordisk Investigational Site Graz Austria 8036
15 Novo Nordisk Investigational Site Innsbruck Austria 6020
16 Novo Nordisk Investigational Site Wien Austria 1090
17 Novo Nordisk Investigational Site Wien Austria 1130
18 Novo Nordisk Investigational Site Wien Austria A 1170
19 Novo Nordisk Investigational Site Goiânia Goias Brazil 74605-020
20 Novo Nordisk Investigational Site Curitiba Parana Brazil 80030-110
21 Novo Nordisk Investigational Site Porto Alegre Rio Grande Do Sul Brazil 90430-001
22 Novo Nordisk Investigational Site São Paulo Sao Paulo Brazil 01228-200
23 Novo Nordisk Investigational Site São Paulo Sao Paulo Brazil 05403-000
24 Novo Nordisk Investigational Site Ribeirao Preto Brazil 14049-900
25 Novo Nordisk Investigational Site Edmonton Alberta Canada T6G 2E1
26 Novo Nordisk Investigational Site Vancouver British Columbia Canada V5Z 1M9
27 Novo Nordisk Investigational Site St John's Newfoundland and Labrador Canada A1B 3V6
28 Novo Nordisk Investigational Site Halifax Nova Scotia Canada B3K 6R8
29 Novo Nordisk Investigational Site Cambridge Ontario Canada N1R 7L6
30 Novo Nordisk Investigational Site London Ontario Canada N6G 2V4
31 Novo Nordisk Investigational Site Toronto Ontario Canada M4N 3M5
32 Novo Nordisk Investigational Site Toronto Ontario Canada M5T 3L9
33 Novo Nordisk Investigational Site PQ Quebec Canada G1L 3L5
34 Novo Nordisk Investigational Site Zagreb Croatia 10 000
35 Novo Nordisk Investigational Site Aarhus N Denmark 8200
36 Novo Nordisk Investigational Site København ø Denmark 2100
37 Novo Nordisk Investigational Site Athens Greece 11521
38 Novo Nordisk Investigational Site Athens Greece GR-11528
39 Novo Nordisk Investigational Site Larissa Greece GR-41110
40 Novo Nordisk Investigational Site Nea Efkarpia - Thessaloniki Greece GR-56403
41 Novo Nordisk Investigational Site Dublin 2 Ireland
42 Novo Nordisk Investigational Site Dublin Ireland DUBLIN 7
43 Novo Nordisk Investigational Site Galway Ireland H91 YR71
44 Novo Nordisk Investigational Site Petach Tikva Israel 49100
45 Novo Nordisk Investigational Site Rehovot Israel 76100
46 Novo Nordisk Investigational Site Milano Italy 20122
47 Novo Nordisk Investigational Site Milano Italy 20132
48 Novo Nordisk Investigational Site Padova Italy 35143
49 Novo Nordisk Investigational Site Roma Italy 00189
50 Novo Nordisk Investigational Site Sant'Andrea Delle Fratte (PG) Italy 06129
51 Novo Nordisk Investigational Site Torino Italy 10126
52 Novo Nordisk Investigational Site Ekaterinburg Russian Federation 620028
53 Novo Nordisk Investigational Site Kirov Russian Federation 610014
54 Novo Nordisk Investigational Site Moscow Russian Federation 101000
55 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 199034
56 Novo Nordisk Investigational Site Saratov Russian Federation 410039
57 Novo Nordisk Investigational Site Tomsk Russian Federation 634050
58 Novo Nordisk Investigational Site Ulianovsk Russian Federation 432063
59 Novo Nordisk Investigational Site Yoshkar-Ola Russian Federation 424004
60 Novo Nordisk Investigational Site Belgrade Serbia 11000
61 Novo Nordisk Investigational Site Barcelona Spain 08025
62 Novo Nordisk Investigational Site Bath United Kingdom BA1 3NG
63 Novo Nordisk Investigational Site Bradford United Kingdom BD9 6RJ
64 Novo Nordisk Investigational Site Cambridge United Kingdom CB2 2QQ
65 Novo Nordisk Investigational Site High Wycombe United Kingdom HP11 2TT
66 Novo Nordisk Investigational Site Leeds United Kingdom LS9 7TF
67 Novo Nordisk Investigational Site Middlesbrough United Kingdom TS4 3BW
68 Novo Nordisk Investigational Site Norwich United Kingdom NR4 7UQ
69 Novo Nordisk Investigational Site Nottingham United Kingdom NG7 2UH
70 Novo Nordisk Investigational Site Oxford United Kingdom OX3 7LE
71 Novo Nordisk Investigational Site Truro United Kingdom TR1 3LJ

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03377699
Other Study ID Numbers:
  • NN1250-4300
  • U1111-1191-3018
  • 2017-000048-17
First Posted:
Dec 19, 2017
Last Update Posted:
Apr 27, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:

Study Results

Participant Flow

Recruitment Details The trial was conducted at 56 sites in 14 countries as follows (number of sites that screened participants/number of sites that randomised participants):Argentina (5/4); Australia (7/7); Austria (3/3); Brazil (6/6); Canada (6/5); Croatia (1/1); Denmark (2/2); Greece (3/3); Ireland (2/2); Israel (2/2); Italy (5/5); Russian Federation (8/8); Serbia (2/2) and United Kingdom (8/6).
Pre-assignment Detail Based on participant pregnancy status, either non-pregnant with the intention to become pregnant or pregnant from gestational Week (GW) 8-13 + 6 days were randomised in a 1:1 ratio to receive either Insulin Degludec (IDeg) or Insulin Detemir (IDet) in combination with Insulin Aspart (IAsp) as subcutaneous injection.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Period Title: Overall Study
STARTED 111 114
Treated 110 112
SASpregnant 91 94
FASpregnant 92 96
COMPLETED 89 89
NOT COMPLETED 22 25

Baseline Characteristics

Arm/Group Title IDeg IDet Total
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Total of all reporting groups
Overall Participants 111 114 225
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
31.2
(5.20)
31.1
(5.28)
31.2
(5.23)
Sex: Female, Male (Count of Participants)
Female
111
100%
114
100%
225
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
24
21.6%
14
12.3%
38
16.9%
Not Hispanic or Latino
87
78.4%
100
87.7%
187
83.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
1
0.9%
1
0.4%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
0.9%
0
0%
1
0.4%
White
106
95.5%
108
94.7%
214
95.1%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
4
3.6%
5
4.4%
9
4%

Outcome Measures

1. Primary Outcome
Title Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
Description Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.
Time Frame From GW 16 to GW 36

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 84 84
in-trial
6.30
(0.70)
6.26
(0.73)
on-treatment
6.32
(0.69)
6.26
(0.71)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDeg, IDet
Comments Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Mean treatment difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.31 to 0.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IDeg, IDet
Comments Secondary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.
Type of Statistical Test Equivalence
Comments Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.
Statistical Test of Hypothesis p-Value 0.3881
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Mean treatment difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.27 to 0.11
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title 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)
Description Number of participants who achieved pre-defined HbA1c targets ≤ 6.0% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.0% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.0% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame From GW 16 to GW 36

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 84 84
Yes
36
32.4%
31
27.2%
No
48
43.2%
53
46.5%
3. Secondary Outcome
Title Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
Description Number of participants who achieved pre-defined HbA1c targets ≤ 6.5% prior to delivery after GW 16 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≤ 6.5% HbA1c whereas 'No' infers number of participants who have not achieved ≤ 6.5% HbA1c. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame From GW 16 to GW 36

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 84 84
Yes
58
52.3%
53
46.5%
No
26
23.4%
31
27.2%
4. Secondary Outcome
Title Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)
Description Mean of post-prandial glucose (PPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. Average PPG is defined as the average of the available blood glucouse (BG) measurements 90 minutes after breakfast, lunch and main evening meal respectively. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame From GW 16 to GW 36

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 75 72
Mean (Standard Deviation) [mmol/L]
7.37
(1.35)
6.96
(1.63)
5. Secondary Outcome
Title Last Planned Fasting Plasma Glucose Prior to Delivery
Description Mean of fasting plasma glucose (FPG) data collected from GW 16 to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from in-trial observation period. The in-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame From GW 16 to GW 36

Outcome Measure Data

Analysis Population Description
FASpregnant which included all randomised pregnant women during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 82 83
Mean (Standard Deviation) [mmol/L]
6.17
(2.05)
6.79
(2.47)
6. Secondary Outcome
Title Number of Hypoglycaemic Episodes During the Pregnancy Period
Description Number of treatment emergent hypoglycaemic episodes during the pregnancy period is presented. Hypoglycaemic episode (plasma glucose <= 3.9 mmol/L (70 milligrams per decilitre (mg/dL)) Or > 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs on or after the first day of trial product administration, and no later than 7 days from the last day on trial product. The endpoint was evaluated based on the data from pregnancy period. Pregnancy period started from first day of pregnancy (date of conception corresponding to the first day in GW 2) or randomisation (whichever comes last) to the date of delivery.
Time Frame From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Number [Episodes]
5431
5982
7. Secondary Outcome
Title Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
Description Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. Eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between pregnancy baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.
Time Frame From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Yes
2
1.8%
2
1.8%
No
79
71.2%
79
69.3%
Missing
10
9%
13
11.4%
Yes
2
1.8%
2
1.8%
No
79
71.2%
79
69.3%
Missing
10
9%
13
11.4%
8. Secondary Outcome
Title Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
Description Sight-threatening retinopathy is defined as proliferative retinopathy or maculopathy. For pregnant women, eye examination was performed by fundus photography or pharmacologically dilated fundoscopy to identify if participants have developed sight-threatening retinopathy. The number of participants who developed sight-threatening retinopathy between treatment baseline to the end of treatment is presented. In the reported data, 'Yes' infers number of participants who developed sight-threatening retinopathy whereas 'No' infers number of participants who have not developed sight-threatening retinopathy.
Time Frame From treatment baseline (week 0) to end of treatment (28 days after delivery)

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Yes
2
1.8%
2
1.8%
No
79
71.2%
79
69.3%
Missing
10
9%
13
11.4%
Yes
2
1.8%
2
1.8%
No
79
71.2%
79
69.3%
Missing
10
9%
13
11.4%
9. Secondary Outcome
Title Number of Adverse Events During Pregnancy Period
Description Number of adverse events (AEs) during pregnancy period is reported. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs presented are treatment-emergent AEs (TEAEs). The TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time Frame From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Number [Events]
429
328
10. Secondary Outcome
Title 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)
Description Number of participants with one or more events of pre-eclampsia during pregnancy period is reported. Pre-eclampsia was defined as new-onset hypertension (greater than or equal to) ≥ 140 millimeters of mercury (mmHg) systolic or ≥ 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart) occurring from GW 20 to delivery and simultaneous proteinuria (defined as ≥ 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of ≥ 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, or other severe organ involvement. In the reported data, 'Yes' infers number of participants who had pre-eclampsia events whereas 'No' infers number of participants who have not had pre-eclampsia events.
Time Frame From GW 20 to delivery

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Yes
12
10.8%
7
6.1%
No
79
71.2%
87
76.3%
11. Secondary Outcome
Title Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
Description Number of participants who had delivered by which mode of delivery (vaginal, operative vaginal, planned caesarean section or unplanned caesarean section delivery) is presented. Planned caesarean section: decision taken > 8 hours prior to delivery. Unplanned caesarean section: decision taken ≤ 8 hours prior to delivery. In case of 'early foetal death' or if the participant did not fill the pregnancy outcome form then mode of delivery was reported as 'missing'.
Time Frame At birth

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Spontaneous vaginal birth
11
9.9%
18
15.8%
Planned caesarean section
42
37.8%
45
39.5%
Operative vaginal birth
8
7.2%
9
7.9%
Non planned caesarean section
23
20.7%
15
13.2%
Missing
7
6.3%
7
6.1%
12. Secondary Outcome
Title Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery
Description Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented.
Time Frame From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)

Outcome Measure Data

Analysis Population Description
SASpregnant included all randomised women exposed to at least one dose of trial product and who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 85 84
Mean (Standard Deviation) [Kilogram (Kg)]
11.97
(4.79)
10.81
(4.55)
13. Secondary Outcome
Title Birth Weight for Live Birth Infants
Description Mean birth weight for live birth infants is presented. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame At birth

Outcome Measure Data

Analysis Population Description
Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 86 84
Mean (Standard Deviation) [grams (g)]
3691.0
(628.01)
3490.2
(629.94)
14. Secondary Outcome
Title Birth Weight Standard Deviation (SD) Score for Live Birth Infants
Description Mean of birth weight SD score for live infants is presented. Birth weight SD score indicates how far an infant's score deviates from the mean of the reference population of same age and same sex born at the same gestational week as per local normal curves. The SD score of 0 indicates that the infants born weigh approximately the same, negative score indicates that the infants born weigh lesser and positive score indicates that the infants born weigh more when compared with the reference population. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame At birth

Outcome Measure Data

Analysis Population Description
Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 66 59
Mean (Standard Deviation) [Standard Deviation score]
1.7
(1.20)
1.2
(1.22)
15. Secondary Outcome
Title Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
Description Number of live born infants with birth weight <10th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants.In the reported data,'Yes' infers number of live born infants with birth weight <10th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not <10th percentile for gestational age and sex.Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.Endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion,up to 24 months.Date of trial completion:final scheduled follow-up visit (delivery + 58 days).
Time Frame At birth

Outcome Measure Data

Analysis Population Description
Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 86 85
Yes
1
0.9%
3
2.6%
No
84
75.7%
81
71.1%
Unaddressed
1
0.9%
1
0.9%
16. Secondary Outcome
Title Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
Description Number of live born infants with birth weight >90th percentile for gestational age and sex is presented.It was assessed using local birth weight percentile curves.The unit of measure 'participants' infers number of live infants. In the reported data,'Yes' infers number of live born infants with birth weight >90th percentile for gestational age and sex whereas 'No' infers number of live born infants birth weight is not >90th percentile for gestational age and sex.Unaddressed category refers to cases where either parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if THE participants did not fill the pregnancy outcome form.The endpoint was evaluated based on the data from in-trial observation period:started at randomization and ended at the date of trial completion,up to 24 months. Date of trial completion:final scheduled follow-up visit (delivery + 58 days).
Time Frame At birth

Outcome Measure Data

Analysis Population Description
Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 86 85
Yes
55
49.5%
43
37.7%
No
30
27%
41
36%
Unaddressed
1
0.9%
1
0.9%
17. Secondary Outcome
Title Number of Participants With Pre-term Delivery
Description Number of pregnant women who had pre-term delivery is presented. Pre-term delivery refers to delivery in < 37 completed GWs. In the reported data, 'Yes' infers number of participants who had pre-term delivery whereas 'No' infers number of participants who has not had pre-term delivery. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion,up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery+58 days). For participants who had not attended the follow-up visit,the date of trial completion was the date of the last participant-investigator contact.
Time Frame At birth

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised women who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 92 96
Yes
34
30.6%
26
22.8%
No
57
51.4%
66
57.9%
Unaddressed
1
0.9%
4
3.5%
18. Secondary Outcome
Title Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
Description Number of participants who had early foetal death (delivery before 20 completed GWs) is presented. In the reported data, 'Yes' infers early foetal deaths whereas 'No' infers no foetal deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame At birth

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised women who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 92 96
Yes
4
3.6%
5
4.4%
No
87
78.4%
87
76.3%
Unaddressed
1
0.9%
4
3.5%
19. Secondary Outcome
Title Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)
Description Number of participants who had foetal/infant loss at delivery is presented. Perinatal mortality: death of foetus/infant between ≥ 20 completed GWs before delivery and <1 completed week after delivery). In the reported data, 'Yes' infers early foetal/infant deaths whereas 'No' infers no foetal/infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion, up to 24 months. Date of trial completion: final scheduled follow-up visit (delivery + 58 days).
Time Frame Between at least 20 completed GWs before delivery and before 7 completed days after delivery

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised women who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 92 96
Yes
0
0%
0
0%
No
91
82%
92
80.7%
Unaddressed
1
0.9%
4
3.5%
20. Secondary Outcome
Title Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
Description Number of participants who had infant loss after delivery is presented. Neonatal mortality: death of infant between ≥7 completed days after delivery and < 28 completed days after delivery. In the reported data, 'Yes' infers infant deaths whereas 'No' infers no infant deaths. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form. The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame Between at least 7 completed days after delivery and before 28 completed days after delivery

Outcome Measure Data

Analysis Population Description
FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 92 96
Yes
0
0%
0
0%
No
91
82%
92
80.7%
Unaddressed
1
0.9%
4
3.5%
21. Secondary Outcome
Title Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants
Description Number of participants who delivered foetuses/infants with abnormalities (classified according to EUROCAT) is presented. Presence of major abnormalities were based on adjudicated data, as after adjudication congenital anomalies were classified into major or minor anomalies or in other categories. In reported data, 'Yes' infers presence of major abnormalities whereas 'No' infers absence of major abnormalities in foetus/infant. The endpoint was evaluated based on the data from in-trial observation period: started at randomization and ended at the date of trial completion up to 24 months. Date of trial completion : final scheduled follow-up visit (delivery + 58 days).
Time Frame At birth

Outcome Measure Data

Analysis Population Description
FASpregnant included all randomised women who were pregnant during the trial.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 92 96
Yes
8
7.2%
8
7%
No
84
75.7%
88
77.2%
22. Secondary Outcome
Title Number of Participants With Live Born Infants (Yes/no)
Description Number of participants with live born infants is presented. In the reported data, 'Yes' infers number of live infants whereas 'No' infers early foetal death or termination of pregnancy (induced/elective abortion). The endpoint was evaluated based on the data from in-trial observation period which started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact.
Time Frame At birth

Outcome Measure Data

Analysis Population Description
FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = participants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 92 96
Yes
86
77.5%
85
74.6%
No
5
4.5%
7
6.1%
Unaddressed
1
0.9%
4
3.5%
23. Secondary Outcome
Title Number of Adverse Events in the Infant
Description AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs in foetus/infant with particular focus on the AEs from delivery to follow-up are presented.
Time Frame From delivery to final follow-up 30 days after delivery

Outcome Measure Data

Analysis Population Description
Infants who were born to SASpregnant women are included. SASpregnant were randomised women exposed to at least one dose of trial product and who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 91 94
Number [Events]
164
150
24. Secondary Outcome
Title 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)
Description Number of infants with neonatal hypoglycaemic episodes is presented. Neonatal hypoglycaemic episodes defined as plasma glucose ≤ 1.7 mmol/L (31 mg/dL) during the first 24 hours after birth or below or equal to 2.5 mmol/L (45 mg/dl) between 24 hours and 48 hours after birth. In the reported data, 'Yes' infers number of infants with neonatal hypoglycaemic episodes whereas 'No' infers number of infants with no neonatal hypoglycaemic episodes. Unaddressed category refers to the cases where either the parents of the infant had not given consent to share information after delivery or the participants who were withdrawn from trial and they did not give any further information or if the participants did not fill the pregnancy outcome form.
Time Frame During between 24 and 48 hours after birth

Outcome Measure Data

Analysis Population Description
Infants who were born to FASpregnant women are included. FASpregnant is equal to randomised women who were pregnant during the trial. Overall Number of Participants Analyzed = infants with available data.
Arm/Group Title IDeg IDet
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
Measure Participants 86 85
Yes
20
18%
19
16.7%
No
64
57.7%
65
57%
Unaddressed category
2
1.8%
1
0.9%
Yes
4
3.6%
5
4.4%
No
77
69.4%
78
68.4%
Unaddressed category
5
4.5%
2
1.8%

Adverse Events

Time Frame For IDeg; IDet : From first day of study drug administration until final follow-up (maximum 25 months) For IDeg infants; IDet infants:From delivery until follow-up (maximum 2 months) All adverse events are TEAEs. A TEAE is defined as event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomized treatment.
Adverse Event Reporting Description For IDeg; IDet: SASall included all randomised women exposed to at least one dose of trial product. For IDeg infants; IDet infants: Live infants born to SASpregnant women are included. SASpregnant is equal to randomised women exposed to at least one dose of trial product and who were pregnant during the trial. AE data is presented for both participants and infants born to SASpregnat participants during the trial. Hence the total number differs from participant flow section.
Arm/Group Title IDeg IDet IDegInf IDetInf
Arm/Group Description Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDeg once daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexTouch and FlexPen pen injectors respectively. After randomization, the IDeg doses were adjusted once weekly to reach the glycaemic target of 4.0 - 5.0 millimoles per liter (mmol/L). It was based on mean of 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 days prior to visit and on the day of the visit. If one of the SMPG values was below target of 4.0 mmol/L, the insulin dose was reduced: (less than) <3.1 mmol/L: -4 units (U) and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L: no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and (greater than) >15.0 mmol/L- +6U. On the other hand, for pregnant women, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L. Infants born to the participants who received the following treatment were included in this arm: Participants were to receive IDet once or twice daily in combination with IAsp 2-4 times daily with meals as subcutaneous injection using FlexPen pen injector. The dose adjustments were made with a glycaemic target of 4.0 - 5.0 mmol/L. Dose adjustments: for IDet once daily - based on mean of 3 pre-breakfast SMPG values; for IDet twice daily - morning doses - based on mean pre-main evening meal SMPG values whereas the evening doses - based on mean pre-breakfast SMPG values. If one of the pre-main evening meal SMPG values were below target of 4.0 mmol/L, the insulin dose was reduced: <3.1 mmol/L: -4U and 3.1 - 3.9 mmol/L: -2U. If the mean was: 4.0-5.0 mmol/L- no adjustment; 5.1 - 10.0 mmol/L: +2U, 10.1 - 15.0 mmol/L: +4U and >15.0 mmol/L: +6U. For pregnant, the SMPG was measured 60 minutes after main meal and the IAsp doses were optimized at investigator's discretion based on the participant's SMPG values with target value (less than or equal to) ≤7.8 mmol/L.
All Cause Mortality
IDeg IDet IDegInf IDetInf
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/112 (0%) 4/91 (4.4%) 7/94 (7.4%)
Serious Adverse Events
IDeg IDet IDegInf IDetInf
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 38/110 (34.5%) 33/112 (29.5%) 37/91 (40.7%) 42/94 (44.7%)
Blood and lymphatic system disorders
Anaemia of pregnancy 1/110 (0.9%) 1 2/112 (1.8%) 2 0/91 (0%) 0 0/94 (0%) 0
Congenital, familial and genetic disorders
ABO haemolytic disease of newborn 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Ankyloglossia congenital 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 3/94 (3.2%) 3
Atrial septal defect 0/110 (0%) 0 0/112 (0%) 0 2/91 (2.2%) 2 1/94 (1.1%) 1
Congenital naevus 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Congenital pneumonia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Congenital pyelocaliectasis 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Dacryostenosis congenital 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Developmental hip dysplasia 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
External auditory canal atresia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Haemangioma congenital 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Hydrocele 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Kidney duplex 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Microtia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Newborn persistent pulmonary hypertension 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Pyloric stenosis 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Ventricular septal defect 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 3/94 (3.2%) 3
Anencephaly 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Bladder agenesis 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Enteric duplication 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Foetal malformation 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 3 0/94 (0%) 0
Polydactyly 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Renal aplasia 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Ear and labyrinth disorders
Hypoacusis 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Eye disorders
Diabetic retinal oedema 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Macular oedema 1/110 (0.9%) 2 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Lacrimal mucocoele 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Gastrointestinal disorders
Abdominal pain 2/110 (1.8%) 2 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Diarrhoea 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Vomiting 2/110 (1.8%) 2 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Dysphagia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Gastrooesophageal reflux disease 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Haematochezia 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Necrotising enterocolitis neonatal 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
General disorders
Injection site hypersensitivity 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Hepatobiliary disorders
Cholestasis of pregnancy 2/110 (1.8%) 2 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Hyperbilirubinaemia neonatal 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Infections and infestations
Bacterial vaginosis 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Gastroenteritis 1/110 (0.9%) 2 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Pyelonephritis 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Urinary tract infection 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Bronchiolitis 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 2/94 (2.1%) 2
Respiratory syncytial virus infection 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Sepsis 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Sepsis neonatal 0/110 (0%) 0 0/112 (0%) 0 5/91 (5.5%) 5 1/94 (1.1%) 1
Systemic bacterial infection 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Injury, poisoning and procedural complications
Accidental overdose 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Fall 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Fibula fracture 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Medication error 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Postoperative wound complication 2/110 (1.8%) 2 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Tibia fracture 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Fracture of clavicle due to birth trauma 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Humerus fracture 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Investigations
Blood glucose increased 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Blood ketone body increased 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Medical observation 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Cardiac murmur 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Ultrasound foetal abnormal 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Metabolism and nutrition disorders
Diabetes mellitus inadequate control 2/110 (1.8%) 2 2/112 (1.8%) 2 0/91 (0%) 0 0/94 (0%) 0
Diabetic metabolic decompensation 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Hypoglycaemia 4/110 (3.6%) 7 6/112 (5.4%) 7 0/91 (0%) 0 0/94 (0%) 0
Hyponatraemia 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Hypercalcaemia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Hypoglycaemia neonatal 0/110 (0%) 0 0/112 (0%) 0 5/91 (5.5%) 5 4/94 (4.3%) 4
Neonatal hypocalcaemia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Poor feeding infant 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Musculoskeletal and connective tissue disorders
Back pain 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Haemangioma of skin 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 2/94 (2.1%) 2
Nervous system disorders
Dizziness postural 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Headache 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Hypoglycaemic unconsciousness 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Sciatica 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Intraventricular haemorrhage neonatal 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Unresponsive to stimuli 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Pregnancy, puerperium and perinatal conditions
Abortion missed 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 2/94 (2.1%) 2
Abortion spontaneous 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 2/94 (2.1%) 2
Abortion threatened 3/110 (2.7%) 3 2/112 (1.8%) 2 0/91 (0%) 0 0/94 (0%) 0
Anembryonic gestation 0/110 (0%) 0 0/112 (0%) 0 2/91 (2.2%) 2 1/94 (1.1%) 1
Cervical incompetence 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Eclampsia 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Foetal hypokinesia 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Gestational hypertension 3/110 (2.7%) 3 6/112 (5.4%) 6 0/91 (0%) 0 0/94 (0%) 0
Gestational oedema 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
HELLP syndrome 3/110 (2.7%) 3 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Haemorrhage in pregnancy 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Placental insufficiency 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Polyhydramnios 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Postpartum haemorrhage 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Pre-eclampsia 6/110 (5.5%) 6 2/112 (1.8%) 2 0/91 (0%) 0 0/94 (0%) 0
Premature rupture of membranes 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Premature separation of placenta 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Preterm premature rupture of membranes 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Threatened labour 2/110 (1.8%) 2 4/112 (3.6%) 5 0/91 (0%) 0 0/94 (0%) 0
Uterine contractions abnormal 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Uterine hypotonus 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Cephalhaematoma 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Foetal distress syndrome 0/110 (0%) 0 0/112 (0%) 0 4/91 (4.4%) 4 3/94 (3.2%) 3
Jaundice neonatal 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 5/94 (5.3%) 5
Poor weight gain neonatal 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Premature baby 0/110 (0%) 0 0/112 (0%) 0 9/91 (9.9%) 9 3/94 (3.2%) 3
Shoulder dystocia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 1/94 (1.1%) 1
Weight decrease neonatal 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Foetal death 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 1/94 (1.1%) 1
Oligohydramnios 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Renal and urinary disorders
Pyelocaliectasis 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 3/94 (3.2%) 3
Reproductive system and breast disorders
Pelvic pain 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Shortened cervix 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Uterine haematoma 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Vaginal haemorrhage 1/110 (0.9%) 1 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Respiratory, thoracic and mediastinal disorders
Immature respiratory system 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 0/94 (0%) 0
Neonatal asphyxia 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 1/94 (1.1%) 1
Neonatal respiratory distress 0/110 (0%) 0 0/112 (0%) 0 1/91 (1.1%) 1 2/94 (2.1%) 2
Neonatal respiratory distress syndrome 0/110 (0%) 0 0/112 (0%) 0 9/91 (9.9%) 9 1/94 (1.1%) 1
Neonatal respiratory failure 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Neonatal tachypnoea 0/110 (0%) 0 0/112 (0%) 0 0/91 (0%) 0 1/94 (1.1%) 1
Transient tachypnoea of the newborn 0/110 (0%) 0 0/112 (0%) 0 3/91 (3.3%) 3 2/94 (2.1%) 2
Surgical and medical procedures
Diabetes mellitus management 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Maternal therapy to enhance foetal lung maturity 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Vascular disorders
Hypertension 1/110 (0.9%) 1 0/112 (0%) 0 0/91 (0%) 0 0/94 (0%) 0
Thrombophlebitis 0/110 (0%) 0 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Other (Not Including Serious) Adverse Events
IDeg IDet IDegInf IDetInf
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 76/110 (69.1%) 61/112 (54.5%) 17/91 (18.7%) 20/94 (21.3%)
Blood and lymphatic system disorders
Anaemia 22/110 (20%) 22 16/112 (14.3%) 16 0/91 (0%) 0 0/94 (0%) 0
Gastrointestinal disorders
Abdominal pain 6/110 (5.5%) 9 1/112 (0.9%) 1 2/91 (2.2%) 2 0/94 (0%) 0
Abdominal pain upper 2/110 (1.8%) 2 6/112 (5.4%) 8 0/91 (0%) 0 0/94 (0%) 0
Diarrhoea 8/110 (7.3%) 9 1/112 (0.9%) 1 0/91 (0%) 0 1/94 (1.1%) 1
Nausea 7/110 (6.4%) 7 7/112 (6.3%) 10 0/91 (0%) 0 0/94 (0%) 0
Vomiting 8/110 (7.3%) 8 6/112 (5.4%) 8 1/91 (1.1%) 1 0/94 (0%) 0
General disorders
Oedema peripheral 8/110 (7.3%) 9 1/112 (0.9%) 1 0/91 (0%) 0 0/94 (0%) 0
Hepatobiliary disorders
Hyperbilirubinaemia 0/110 (0%) 0 0/112 (0%) 0 2/91 (2.2%) 2 7/94 (7.4%) 8
Infections and infestations
Influenza 5/110 (4.5%) 6 7/112 (6.3%) 10 0/91 (0%) 0 0/94 (0%) 0
Nasopharyngitis 21/110 (19.1%) 30 23/112 (20.5%) 45 0/91 (0%) 0 0/94 (0%) 0
Pharyngitis 7/110 (6.4%) 7 2/112 (1.8%) 2 0/91 (0%) 0 0/94 (0%) 0
Sinusitis 2/110 (1.8%) 2 6/112 (5.4%) 6 0/91 (0%) 0 0/94 (0%) 0
Urinary tract infection 11/110 (10%) 16 9/112 (8%) 11 0/91 (0%) 0 0/94 (0%) 0
Metabolism and nutrition disorders
Hypoglycaemia 0/110 (0%) 0 0/112 (0%) 0 6/91 (6.6%) 8 8/94 (8.5%) 8
Nervous system disorders
Headache 8/110 (7.3%) 18 10/112 (8.9%) 16 0/91 (0%) 0 0/94 (0%) 0
Pregnancy, puerperium and perinatal conditions
Placental insufficiency 7/110 (6.4%) 7 5/112 (4.5%) 5 0/91 (0%) 0 0/94 (0%) 0
Polyhydramnios 6/110 (5.5%) 6 8/112 (7.1%) 8 1/91 (1.1%) 1 0/94 (0%) 0
Pre-eclampsia 4/110 (3.6%) 4 6/112 (5.4%) 7 0/91 (0%) 0 0/94 (0%) 0
Jaundice neonatal 0/110 (0%) 0 0/112 (0%) 0 5/91 (5.5%) 5 5/94 (5.3%) 5
Renal and urinary disorders
Proteinuria 6/110 (5.5%) 7 4/112 (3.6%) 4 0/91 (0%) 0 0/94 (0%) 0
Reproductive system and breast disorders
Vaginal haemorrhage 7/110 (6.4%) 12 5/112 (4.5%) 5 0/91 (0%) 0 0/94 (0%) 0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 5/110 (4.5%) 5 7/112 (6.3%) 10 0/91 (0%) 0 0/94 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.

Results Point of Contact

Name/Title Clinical Transparency Anchor and Disclosure (1452)
Organization Novo Nordisk A/S
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03377699
Other Study ID Numbers:
  • NN1250-4300
  • U1111-1191-3018
  • 2017-000048-17
First Posted:
Dec 19, 2017
Last Update Posted:
Apr 27, 2022
Last Verified:
Mar 1, 2022