Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-25 @ 12:56 AM
Study NCT ID:
NCT03770767
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Birth weight standard deviation score', 'timeFrame': 'At delivery', 'description': 'Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender'}], 'secondaryOutcomes': [{'measure': 'HbA1c levels', 'timeFrame': 'At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery', 'description': 'HbA1c levels in pregnancy, one and three months after delivery'}, {'measure': 'Postprandial self-monitoring of plasma glucose (SMPG) levels', 'timeFrame': '9 months', 'description': 'Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy'}, {'measure': 'Preprandial self-monitoring of plasma glucose (SMPG) levels', 'timeFrame': '9 months', 'description': 'Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy'}, {'measure': 'Insulin treatment and dose (IU) including insulin pump settings', 'timeFrame': 'At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery', 'description': 'Type of insulin, dose (IU) during pregnancy, around delivery and until 3 months after delivery. In women on insulin pump therapy: appropriate insulin pump dosing (IU) during pregnancy, around delivery and until 3 months after delivery.'}, {'measure': 'Continuous glucose monitoring data', 'timeFrame': '9 months', 'description': 'The amount of time during CGM use spent in the target range 3.5-7.8 mmol/l, with glucose \\<3.5 mmol/L and glucose \\>7.8 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively, in pregnancy and around delivery (in the morning for induction of labour or planned caesarean section). • The percentage of time during the first one-week period after delivery spent in the target range 3.9-10.0 mmol/L, with glucose \\<3.9 mmol/L and glucose \\>10.0 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively.'}, {'measure': 'Severe hypoglycemia', 'timeFrame': '2 years', 'description': 'The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth'}, {'measure': 'Mild hypoglycaemia', 'timeFrame': '12 months', 'description': 'The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.'}, {'measure': 'Maternal weight', 'timeFrame': 'At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery', 'description': 'Maternal weight in pregnancy and after delivery'}, {'measure': 'Pregnancy complications and outcomes', 'timeFrame': '9 months', 'description': 'The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death'}, {'measure': 'Fetal overgrowth', 'timeFrame': 'At birth', 'description': 'The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or \\>90th percentile'}, {'measure': 'Infant weight', 'timeFrame': '3 months', 'description': 'Infant weight during the first 3 months of life'}, {'measure': 'Neonatal morbidity (neonatal hypoglycaemia, jaundice, respiratory distress and duration of stay in neonatal intensive care unit) and infant morbidity evaluated as hospitalization during the first 3 months of life (after discharge in the neonatal period)', 'timeFrame': '3 months', 'description': 'Neonatal morbidity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '37804858', 'type': 'DERIVED', 'citation': 'Norgaard SK, Soholm JC, Mathiesen ER, Norgaard K, Clausen TD, Holmager P, Do NC, Damm P, Ringholm L. Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Nov;11(11):811-821. doi: 10.1016/S2213-8587(23)00236-X. Epub 2023 Oct 4.'}, {'pmid': '34086494', 'type': 'DERIVED', 'citation': 'Norgaard SK, Mathiesen ER, Norgaard K, Ringholm L. Comparison of Glycemic Metrics Measured Simultaneously by Intermittently Scanned Continuous Glucose Monitoring and Real-Time Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Oct;23(10):665-672. doi: 10.1089/dia.2021.0109. Epub 2021 Jun 25.'}, {'pmid': '33837106', 'type': 'DERIVED', 'citation': 'Norgaard SK, Mathiesen ER, Norgaard K, Clausen TD, Damm P, Ringholm L. CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial. BMJ Open. 2021 Apr 9;11(4):e045650. doi: 10.1136/bmjopen-2020-045650.'}]}, 'descriptionModule': {'briefSummary': 'A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Women, age ≥ 18 years\n* Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months\n* Type 2 diabetes (any duration)\n* Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks\n* Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality\n* Women with type 1 diabetes using an insulin pump compatible with trial products\n* Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed insulin before pregnancy and willing to change to trial medication according to randomization or to an appropriate long-acting insulin analogue, as indicated\n* Proficiency in Danish to understand oral and written information\n\nExclusion criteria\n\n• Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator'}, 'identificationModule': {'nctId': 'NCT03770767', 'briefTitle': 'Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Randomised Controlled Trial Comparing the Effect of the Faster-acting Insulin Analog - Insulin Fiasp® - Versus Insulin Novorapid® in the Treatment of Women With Type 1 or Type 2 Diabetes During Pregnancy and Lactation. The Copen-fast Trial', 'orgStudyIdInfo': {'id': 'U1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention with insulin Fiasp', 'description': 'Women randomized to insulin Fiasp', 'interventionNames': ['Drug: Faster-acting Aspart insulin Fiasp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control (insulin Novorapid)', 'description': 'Women randomized to insulin NovoRapid', 'interventionNames': ['Drug: Control (insulin Novorapid)']}], 'interventions': [{'name': 'Faster-acting Aspart insulin Fiasp', 'type': 'DRUG', 'otherNames': ['Insulin Fiasp'], 'description': 'Randomization to treatment with insulin Fiasp', 'armGroupLabels': ['Intervention with insulin Fiasp']}, {'name': 'Control (insulin Novorapid)', 'type': 'DRUG', 'otherNames': ['First generation insulin analog'], 'description': 'Randomization to standard treatment with insulin Novorapid', 'armGroupLabels': ['Control (insulin Novorapid)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Pregnant Women with Diabetes, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lene Ringholm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Baseline data can be shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Lene Ringholm', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}