Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01085292
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2010-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2010-03-10', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '30957581', 'type': 'DERIVED', 'citation': 'Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus. A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to provide sufficient safety and dose-response data for a planned Phase IIa proof of concept study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group A: Healthy male and female subjects\n* Group B-D: Patients with type 2 diabetes mellitus according to ADA definition; GFR \\> 60 mL/min; HbA1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria\n\nExclusion Criteria:\n\n* History of or presence of clinically significant diseases with the exception of diabetes (Groups B-D)\n* Concurrent illness that may affect blood glucose other than diabetes\n* Supine blood pressure at screening, after resting for 5 min, of \\>140 mmHg systolic or \\> 90 mmHg diastolic (Group A) or \\> 160 mmHg systolic or \\> 95 mmHg in diabetes mellitus patients (Groups B-D)\n* Clinically significant abnormal ECG at screening\n* Any kidney disease not caused by diabetes or hypertension\n* Type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01085292', 'briefTitle': 'NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'TME Pharma AG'}, 'officialTitle': 'NOX-E36 - A Phase Ib, Multiple Intravenous Dose Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties in Healthy Subjects and Then in Three Groups of Patients With Type 2 Diabetes Mellitus to Compare Three Ascending Dose Regimens in a Double-blind and Placebo-controlled Manner', 'orgStudyIdInfo': {'id': 'SNOXE36C101'}, 'secondaryIdInfos': [{'id': '2010-019148-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Drug: NOX-E36']}, {'type': 'EXPERIMENTAL', 'label': 'Group B - D', 'interventionNames': ['Drug: NOX-E36']}], 'interventions': [{'name': 'NOX-E36', 'type': 'DRUG', 'description': 'Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d', 'armGroupLabels': ['Group A']}, {'name': 'NOX-E36', 'type': 'DRUG', 'description': 'Multiple dose of 0.0625 mg/kg, 0.125 mg/kg, 0.25 mg/kg or placebo i.v. to patients with type 2 diabetes mellitus (ratio 3:1); dosing frequency q2d', 'armGroupLabels': ['Group B - D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Itecra GmbH', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'CTC North MediGate GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'ikfe GmbH', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut fuer Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Grit Landgraf, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Noxxon AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TME Pharma AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Profil Institut für Stoffwechselforschung GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}