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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03377699
Registration number
NCT03377699
Ethics application status
Date submitted
16/11/2017
Date registered
19/12/2017
Date last updated
20/01/2023
Titles & IDs
Public title
Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
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Scientific title
A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes
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Secondary ID [1]
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U1111-1191-3018
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Secondary ID [2]
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NN1250-4300
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Universal Trial Number (UTN)
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Trial acronym
EXPECT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin degludec
Treatment: Drugs - Insulin Aspart
Treatment: Drugs - Insulin detemir
Experimental: Insulin Degludec - Insulin Degludec once daily and Insulin Aspart 2-4 times daily
Active Comparator: Insulin Determir - Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily
Treatment: Drugs: Insulin degludec
Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months
Treatment: Drugs: Insulin Aspart
Injection for subcutaneous (s.c., under the skin) use 2-4 times daily with meals. The total trial duration for subjects will be maximum 25 months
Treatment: Drugs: Insulin detemir
Injection for subcutaneous (s.c., under the skin) use, once daily or twice daily. The total trial duration for subjects will be maximum 25 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
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Assessment method [1]
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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.
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Timepoint [1]
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From GW 16 to GW 36
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Secondary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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From GW 16 to GW 36
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Secondary outcome [2]
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Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
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Assessment method [2]
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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.
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Timepoint [2]
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From GW 16 to GW 36
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Secondary outcome [3]
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Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)
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Assessment method [3]
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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.
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Timepoint [3]
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From GW 16 to GW 36
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Secondary outcome [4]
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Last Planned Fasting Plasma Glucose Prior to Delivery
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Assessment method [4]
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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.
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Timepoint [4]
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From GW 16 to GW 36
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Secondary outcome [5]
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Number of Hypoglycaemic Episodes During the Pregnancy Period
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Assessment method [5]
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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.
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Timepoint [5]
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From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)
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Secondary outcome [6]
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Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)
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Assessment method [6]
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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.
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Timepoint [6]
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From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery)
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Secondary outcome [7]
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Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)
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Assessment method [7]
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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.
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Timepoint [7]
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From treatment baseline (week 0) to end of treatment (28 days after delivery)
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Secondary outcome [8]
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Number of Adverse Events During Pregnancy Period
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Assessment method [8]
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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.
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Timepoint [8]
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From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)
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Secondary outcome [9]
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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)
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Assessment method [9]
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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.
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Timepoint [9]
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From GW 20 to delivery
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Secondary outcome [10]
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Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery
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Assessment method [10]
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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'.
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Timepoint [10]
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At birth
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Secondary outcome [11]
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Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery
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Assessment method [11]
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Change in body weight from pregnancy baseline to last planned visit prior to delivery is presented.
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Timepoint [11]
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From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth)
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Secondary outcome [12]
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Birth Weight for Live Birth Infants
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Assessment method [12]
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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.
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Timepoint [12]
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At birth
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Secondary outcome [13]
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Birth Weight Standard Deviation (SD) Score for Live Birth Infants
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Assessment method [13]
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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.
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Timepoint [13]
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At birth
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Secondary outcome [14]
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Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)
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Assessment method [14]
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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).
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Timepoint [14]
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At birth
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Secondary outcome [15]
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Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no]
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Assessment method [15]
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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).
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Timepoint [15]
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At birth
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Secondary outcome [16]
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Number of Participants With Pre-term Delivery
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Assessment method [16]
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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.
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Timepoint [16]
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At birth
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Secondary outcome [17]
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Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)
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Assessment method [17]
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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.
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Timepoint [17]
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At birth
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Secondary outcome [18]
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Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)
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Assessment method [18]
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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).
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Timepoint [18]
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Between at least 20 completed GWs before delivery and before 7 completed days after delivery
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Secondary outcome [19]
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Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)
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Assessment method [19]
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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.
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Timepoint [19]
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Between at least 7 completed days after delivery and before 28 completed days after delivery
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Secondary outcome [20]
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Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants
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Assessment method [20]
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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).
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Timepoint [20]
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At birth
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Secondary outcome [21]
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Number of Participants With Live Born Infants (Yes/no)
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Assessment method [21]
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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.
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Timepoint [21]
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At birth
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Secondary outcome [22]
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Number of Adverse Events in the Infant
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Assessment method [22]
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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.
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Timepoint [22]
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From delivery to final follow-up 30 days after delivery
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Secondary outcome [23]
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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)
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Assessment method [23]
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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.
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Timepoint [23]
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During between 24 and 48 hours after birth
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Eligibility
Key inclusion criteria
- Female, age at least 18 years at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus for at least 1 year prior to the day of screening
- Treated with multiple daily subcutaneous insulin injections or continuous subcutaneous
insulin infusion (CSII) or inhaled insulin for at least 90 days prior to the day of
screening - The subject is planning to become pregnant within 12 months from randomisation
and willing to undertake pre-pregnancy counselling or the subject is pregnant with an
intrauterine singleton living foetus (gestational week 8 to 13 (+6 days)) without any
observed anomalies at randomisation, confirmed by an ultrasound scan - HbA1c at screening
below or equal to 8.0% (64 mmol/mol) by central laboratory
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Treatment
with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria within the past 90 days prior to the day of screening - Pregnant and
having proteinuria as evaluated by urine protein-to-creatinine ratio above or equal to 300
mg/g in urine sample measured at screening - Subject being treated or became pregnant with
assistance of in vitro fertilisation or other medical infertility treatment - Receipt of
any concomitant medication contraindicated in pregnancy according to local label within 28
days before screening and between screening and randomisation for non-pregnant subjects and
28 days before conception and between conception and randomisation for pregnant subjects -
Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or pharmacologically dilated fundoscopy performed within the past 90 days prior
to randomisation for non-pregnant subjects or within 28 days prior to randomisation for
pregnant subjects. - History of severe hyperemesis gravidarum (requiring hospitalisation)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/12/2020
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Sample size
Target
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Accrual to date
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Final
225
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Blacktown
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Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - Campbelltown
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Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - Ipswich
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Recruitment hospital [5]
0
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Novo Nordisk Investigational Site - Elizabeth Vale
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Recruitment hospital [6]
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Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [7]
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Novo Nordisk Investigational Site - Parkville
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Recruitment postcode(s) [1]
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0
2148 - Blacktown
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Recruitment postcode(s) [2]
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0
2560 - Campbelltown
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Recruitment postcode(s) [3]
0
0
2065 - St Leonards
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Recruitment postcode(s) [4]
0
0
4305 - Ipswich
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Recruitment postcode(s) [5]
0
0
5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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0
3128 - Box Hill
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Recruitment postcode(s) [7]
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0
3052 - Parkville
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Recruitment outside Australia
Country [1]
0
0
Argentina
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State/province [1]
0
0
Caba
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Córdoba
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Country [3]
0
0
Argentina
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State/province [3]
0
0
Mendoza
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Salta
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Country [5]
0
0
Austria
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State/province [5]
0
0
Graz
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Country [6]
0
0
Austria
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State/province [6]
0
0
Innsbruck
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Country [7]
0
0
Austria
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State/province [7]
0
0
Wien
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Country [8]
0
0
Brazil
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State/province [8]
0
0
Goias
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Country [9]
0
0
Brazil
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State/province [9]
0
0
Parana
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Country [10]
0
0
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Italy
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Russian Federation
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United Kingdom
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Truro
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Funding & Sponsors
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Name
Novo Nordisk A/S
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Summary
Brief summary
The investigators are doing this study to see the effect of insulin degludec in pregnant
women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin
degludec is compared to another medicine called insulin detemir. Participants will either get
insulin degludec or insulin detemir and take it together with a medicine called insulin
aspart - which treatment participants get is decided by chance. Participants will get
pre-filled insulin pens. Participants will need to take blood sugar measurements several
times a day. The study will last between 10 and 25 months depending on whether participants
are already pregnant when they join the study. The number of visits and the tests ( for
example blood and urine samples and ultrasound scans) the participants will have also depends
on whether they are pregnant at study start.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03377699
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03377699
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