Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-01 @ 7:40 AM
Study NCT ID:
NCT07068295
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour', 'timeFrame': '0 to 1 hour after bolus infusion', 'description': 'Measured in milligram per kilogram (mg/kg).'}], 'secondaryOutcomes': [{'measure': 'AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in mg/kg.'}, {'measure': 'AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basal-corrected): Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in percentage (%).'}, {'measure': 'GIR (max,basal-corrected): Maximum observed basal-corrected GIR', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in milligrams per (kilogram \\*minute) (mg/\\[kg\\*min\\]).'}, {'measure': 'AUC(NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in %.'}, {'measure': 'AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in hours\\*picomole per liter (h\\*pmol/L).'}, {'measure': 'AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes', 'timeFrame': '0 to 30 minutes after bolus infusion', 'description': 'Measured in h\\*pmol/L.'}, {'measure': 'AUC(NNC0471-0119,2h-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t', 'timeFrame': '2 to 11 hours after bolus infusion', 'description': 'Measured in h\\*pmol/L.'}, {'measure': 'AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in %.'}, {'measure': 'C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in picomoles per litre (pmol/L).'}, {'measure': 't(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in minutes (Min).'}, {'measure': 't(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration', 'timeFrame': '0 to 11 hours after bolus infusion', 'description': 'Measured in min.'}, {'measure': 'Number of adverse events (AEs)', 'timeFrame': 'From start of first investigational medicinal product (IMP) basal rate infusion (day -1) until completion of post-treatment end of study visit (up to 67 days)', 'description': 'Measure in number of events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18-69 years (both inclusive) at the time of signing the informed consent.\n* Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.\n* Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening.\n* Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \\[(I) U/kg/day\\] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:\n* Any metformin formulation\n* Dipeptidyl peptidase-4 inhibitor (DPP4i)\n* Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)\n* Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.\n* HbA1c lesser than or equal to (≤) 9.5%\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.'}, 'identificationModule': {'nctId': 'NCT07068295', 'briefTitle': 'A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN1471-5026'}, 'secondaryIdInfos': [{'id': 'U1111-1283-0507', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2024-520230-29', 'type': 'OTHER', 'domain': 'European Medical Agency (EMA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC0471-0119 H then Insulin Aspart', 'description': 'Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.', 'interventionNames': ['Drug: NNC0471-0119 H', 'Drug: Insulin Aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Aspart then NNC0471-0119 H', 'description': 'Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.', 'interventionNames': ['Drug: NNC0471-0119 H', 'Drug: Insulin Aspart']}], 'interventions': [{'name': 'NNC0471-0119 H', 'type': 'DRUG', 'description': 'NNC0471-0119 H will be administered subcutaneously.', 'armGroupLabels': ['Insulin Aspart then NNC0471-0119 H', 'NNC0471-0119 H then Insulin Aspart']}, {'name': 'Insulin Aspart', 'type': 'DRUG', 'description': 'Insulin aspart will be administered subcutaneously.', 'armGroupLabels': ['Insulin Aspart then NNC0471-0119 H', 'NNC0471-0119 H then Insulin Aspart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}