Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-02-25 @ 6:46 PM
Study NCT ID:
NCT01508806
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2012-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Curve (AUC)'}], 'secondaryOutcomes': [{'measure': 'AUC (0-t)'}, {'measure': 'Cmax, maximum concentration'}, {'measure': 'tmax, time to reach Cmax'}, {'measure': 't½, terminal half-life'}, {'measure': 'CLR (renal clearance)'}, {'measure': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20002084', 'type': 'RESULT', 'citation': 'Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol. 2009 Dec;68(6):898-905. doi: 10.1111/j.1365-2125.2009.03536.x.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Oceania. The aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups\n* Body Mass Index (BMI) maximum 40 kg/m\\^2\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial product(s) or related products\n* Renal transplanted patients\n* Haemodialysis patients\n* Cardiac problems\n* Uncontrolled treated/untreated hypertension\n* History of alcoholism or drug abuse during the last 12 months\n* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products\n* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator\n* Excessive consumption of food deviating from a normal diet as judged by the Investigator'}, 'identificationModule': {'nctId': 'NCT01508806', 'briefTitle': 'Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Single-centre, Open-label, Trial Investigating the Pharmacokinetics and the Tolerability of Liraglutide in Subjects With Normal Renal Function and in Subjects With Impaired Renal Function', 'orgStudyIdInfo': {'id': 'NN2211-1329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal renal function', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Mild renal impairment', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate renal impairment', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Severe renal impairment', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'End-stage renal disease', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Single dose of 0.75 mg, administered as a subcutaneous injection', 'armGroupLabels': ['End-stage renal disease', 'Mild renal impairment', 'Moderate renal impairment', 'Normal renal function', 'Severe renal impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2856', 'city': 'Christchurch', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site'}], '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'}}}}