Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04136067
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2019-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes
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': 'D000069036', 'term': 'Insulin Glargine'}], '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': ['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': 'PARALLEL', 'interventionModelDescription': '3 cohorts are planned. Each cohort will consist of 12 subjects, with 9 subjects being randomised to receive NNC0268-0965 and 3 subjects being randomised to insulin glargine.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment-emergent adverse events (AEs)', 'timeFrame': 'From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)', 'description': 'Number of events'}], 'secondaryOutcomes': [{'measure': 'Number of treatment-emergent hypoglycaemic episodes', 'timeFrame': 'From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)', 'description': 'Number of episodes'}, {'measure': 'Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state', 'timeFrame': 'From 0 to 24 hours after IMP administration at day 6 (visit 2)', 'description': 'pmol\\*h/l'}, {'measure': 'Maximum observed serum NNC0268-0965 concentration after the last dose', 'timeFrame': 'From 0 to 24 hours after IMP administration at day 6 (visit 2)', 'description': 'pmol/l'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.\n* Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.\n* Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.\n* Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).\n* HbA1c equal to or below 9.5%\n\nExclusion Criteria:\n\n* Male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).\n* Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT04136067', 'briefTitle': 'A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NN1965-4457'}, 'secondaryIdInfos': [{'id': 'U1111-1227-8683', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2019-000754-58', 'type': 'REGISTRY', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC0268-0965', 'description': 'Participants will receive NNC0268-0965', 'interventionNames': ['Drug: NNC0268-0965']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin glargine', 'description': 'Participants will receive insulin glargine', 'interventionNames': ['Drug: insulin glargine']}], 'interventions': [{'name': 'NNC0268-0965', 'type': 'DRUG', 'description': 'One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days', 'armGroupLabels': ['NNC0268-0965']}, {'name': 'insulin glargine', 'type': 'DRUG', 'description': 'One daily dose of 3.0 nmol/kg administered s.c. for 6 days', 'armGroupLabels': ['Insulin glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://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'}}}}