Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-01 @ 3:03 PM
Study NCT ID:
NCT05124457
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DETERMINE: Detemir vs NPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-29', 'mcpReleaseN': 3, 'releaseDate': '2025-07-10'}, {'resetDate': '2025-11-25', 'mcpReleaseN': 4, 'releaseDate': '2025-11-13'}], 'estimatedResultsFirstSubmitDate': '2025-07-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization to receive either insulin NPH or insulin detemir'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Hypoglycemia', 'timeFrame': 'Within the first 24 hours of life', 'description': 'Rate (%) of neonatal hypoglycemia'}, {'measure': 'Prolonged neonatal hypoglycemia', 'timeFrame': 'Neonatal hypoglycemia after the 1st 24 hours of life but before discharge', 'description': 'Rate (%) of prolonged neonatal hypoglycemia'}], 'secondaryOutcomes': [{'measure': 'Neonatal Gastrin Level', 'timeFrame': 'At birth', 'description': 'Sample form cord blood'}, {'measure': 'Neonatal C-Peptide Level', 'timeFrame': 'At birth', 'description': 'Sample from cord blood'}, {'measure': 'Neonatal insulin level', 'timeFrame': 'At birth', 'description': 'Sample from cord blood'}, {'measure': 'Neonatal leptin level', 'timeFrame': 'At birth', 'description': 'Sample from cord blood'}, {'measure': 'Rates of pregnancy induced hypertension', 'timeFrame': '1 year', 'description': 'Maternal rates of preeclampsia, eclampsia, or gestational hypertension'}, {'measure': 'Mode of delivery', 'timeFrame': 'At delivery', 'description': 'Spontaneous vaginal, operative vaginal, cesarean'}, {'measure': 'Gestational Age at delivery', 'timeFrame': 'At delivery', 'description': 'Gestational Age at delivery'}, {'measure': 'Maternal glycemic control', 'timeFrame': '1 year', 'description': 'Rate (%) of in range maternal blood glucose control in antepartum period'}, {'measure': 'Total daily insulin', 'timeFrame': '1 year', 'description': 'Total daily insulin dose in patient'}, {'measure': 'Fetal anomolies', 'timeFrame': 'At birth', 'description': 'Rate (%) of fetal anomolies'}, {'measure': 'Macrosomia', 'timeFrame': 'At birth', 'description': 'Rate (%) of macrosomia'}, {'measure': 'Polyhydramnios', 'timeFrame': 'At birth', 'description': 'Rate (%) of polyhydramnios'}, {'measure': 'Neonatal weight', 'timeFrame': 'At birth', 'description': 'Neonatal weight'}, {'measure': 'Need for supplemental oxygen', 'timeFrame': '1 year', 'description': 'Rate of supplemental oxygen use (%) in neonate'}, {'measure': 'Need for dextrose infusion in neonate', 'timeFrame': '1 year', 'description': 'Rate of dextrose infusion use (%) in neonate'}, {'measure': 'Rates of respiratory distress syndrome', 'timeFrame': '1 year', 'description': 'Rate of RDS (%) in neonate'}, {'measure': '5 Minute APGAR', 'timeFrame': 'At birth', 'description': '5 Minute APGAR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '26810997', 'type': 'BACKGROUND', 'citation': 'Coton SJ, Nazareth I, Petersen I. A cohort study of trends in the prevalence of pregestational diabetes in pregnancy recorded in UK general practice between 1995 and 2012. BMJ Open. 2016 Jan 25;6(1):e009494. doi: 10.1136/bmjopen-2015-009494.'}, {'pmid': '28669379', 'type': 'BACKGROUND', 'citation': 'Melchior H, Kurch-Bek D, Mund M. The Prevalence of Gestational Diabetes. Dtsch Arztebl Int. 2017 Jul 16;114(24):412-418. doi: 10.3238/arztebl.2017.0412.'}, {'pmid': '22851598', 'type': 'BACKGROUND', 'citation': 'Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30.'}, {'pmid': '32396624', 'type': 'BACKGROUND', 'citation': 'Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020 Oct 1;41(5):733-55. doi: 10.1210/endrev/bnaa015.'}, {'pmid': '26070699', 'type': 'BACKGROUND', 'citation': 'Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.'}, {'pmid': '11924935', 'type': 'BACKGROUND', 'citation': 'Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319.'}, {'pmid': '28156005', 'type': 'BACKGROUND', 'citation': "O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD011880. doi: 10.1002/14651858.CD011880.pub2."}, {'pmid': '31498869', 'type': 'BACKGROUND', 'citation': 'Kadakia R, Talbot O, Kuang A, Bain JR, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM, Lowe WL; HAPO Study Cooperative Research Group. Cord Blood Metabolomics: Association With Newborn Anthropometrics and C-Peptide Across Ancestries. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4459-4472. doi: 10.1210/jc.2019-00238.'}, {'pmid': '28637888', 'type': 'BACKGROUND', 'citation': 'Lowe WL Jr, Bain JR, Nodzenski M, Reisetter AC, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM; HAPO Study Cooperative Research Group. Maternal BMI and Glycemia Impact the Fetal Metabolome. Diabetes Care. 2017 Jul;40(7):902-910. doi: 10.2337/dc16-2452.'}, {'pmid': '33865836', 'type': 'BACKGROUND', 'citation': 'Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15.'}, {'pmid': '31168280', 'type': 'BACKGROUND', 'citation': 'Chun J, Strong J, Urquhart S. Insulin Initiation and Titration in Patients With Type 2 Diabetes. Diabetes Spectr. 2019 May;32(2):104-111. doi: 10.2337/ds18-0005.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.ajog.2019.11.450', 'label': 'Abstract'}, {'url': 'https://doi.org/10.1016/j.ajog.2019.11.057', 'label': 'Abstract'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.', 'detailedDescription': 'Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.\n\nExclusion Criteria:\n\n1. Multiple Gestation\n2. Type 1 Diabetes mellatus\n3. Age \\< 18\n4. Known or suspected hypersensitivity to NPH or insulin detemir\n5. Known fetal major malformations\n6. Chronic renal or hepatic insufficiency\n7. Known to be HIV, Hepatitis B, or Hepatitis C positive\n8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)\n9. Insulin dependent before conception'}, 'identificationModule': {'nctId': 'NCT05124457', 'acronym': 'DETERMINE', 'briefTitle': 'DETERMINE: Detemir vs NPH', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study', 'orgStudyIdInfo': {'id': 'DETERMINE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Detemir', 'description': 'Patients are to receive insulin detemir as long acting insulin to control blood sugars', 'interventionNames': ['Drug: Insulin Detemir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin NPH', 'description': 'Patients are to receive insulin NPH as long acting insulin to control blood sugars', 'interventionNames': ['Drug: Insulin NPH']}], 'interventions': [{'name': 'Insulin Detemir', 'type': 'DRUG', 'description': 'Patients are to receive insulin detemir', 'armGroupLabels': ['Insulin Detemir']}, {'name': 'Insulin NPH', 'type': 'DRUG', 'description': 'Patients are to receive insulin NPH', 'armGroupLabels': ['Insulin NPH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina S Han, MD', 'role': 'CONTACT', 'email': 'cshan@mednet.ucla.edu'}, {'name': 'Michael A Richley, MD', 'role': 'CONTACT', 'email': 'mrichley@mednet.ucla.edu'}], 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Michael Richley, MD', 'role': 'CONTACT', 'email': 'mrichley@mednet.ucla.edu', 'phone': '310-794-7274'}, {'name': 'Christina Han, MD', 'role': 'CONTACT', 'email': 'cshan@mednet.ucla.edu', 'phone': '310-794-7274'}], 'overallOfficials': [{'name': 'Christina Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Michael Richley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal-Fetal Medicine Division Director', 'investigatorFullName': 'Christina S. Han', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}