Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01028404
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2009-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2009-12-07', 'studyFirstSubmitQcDate': '2009-12-07', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and severity of adverse events for trial part 1', 'timeFrame': 'from visit 1 to visit 3'}, {'measure': 'Number and severity of adverse events for trial part 2', 'timeFrame': 'from visit 1 to visit 6'}], 'secondaryOutcomes': [{'measure': 'Area under the serum insulin concentration-time curve after a single dose', 'timeFrame': 'after 12 hours'}, {'measure': 'Area under the glucose infusion rate-time curve after a single dose', 'timeFrame': 'after 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.\n\nThe trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FOR TRIAL PART 1, THE FOLLOWING APPLIES:\n* Gender: male\n* Age: 18-55 years\n* BMI (body mass index): 18-28 kg/m2\n* Study participants considered to be healthy\n* FOR TRIAL PART 2, THE FOLLOWING APPLIES:\n* Gender: male or female of no childbearing potential\n* Age: 18-65 years\n* Type 1 diabetes: BMI (body mass index): 18-28 kg/m2\n* Type 2 diabetes: BMI (body mass index): 22-35 kg/m2\n* Type 1 or type 2 diabetes for at least 12 months\n* Type 1 diabetes: Treatment with insulin for at least 12 months\n* Type 2 diabetes: Treatment with insulin for at least 3 months\n\nExclusion Criteria:\n\n* Known or suspected allergy to the trial product or related products\n* Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator\n* Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)'}, 'identificationModule': {'nctId': 'NCT01028404', 'briefTitle': 'A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN1952-3646'}, 'secondaryIdInfos': [{'id': 'U1111-1112-2892', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2009-013282-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial part 1', 'interventionNames': ['Drug: NN1952', 'Drug: insulin aspart', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Trial part 2', 'interventionNames': ['Drug: NN1952', 'Drug: insulin aspart', 'Drug: placebo']}], 'interventions': [{'name': 'NN1952', 'type': 'DRUG', 'description': 'Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.', 'armGroupLabels': ['Trial part 1']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.', 'armGroupLabels': ['Trial part 1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.', 'armGroupLabels': ['Trial part 1']}, {'name': 'NN1952', 'type': 'DRUG', 'description': 'Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.', 'armGroupLabels': ['Trial part 2']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.', 'armGroupLabels': ['Trial part 2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.', 'armGroupLabels': ['Trial part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}