Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT01398267
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
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': 'C542437', 'term': 'aleglitazar'}, {'id': 'D017706', 'term': 'Lisinopril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration rate (mGFR), measured as iohexol clearance', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])', 'timeFrame': '4 weeks'}, {'measure': 'Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)', 'timeFrame': '4 weeks'}, {'measure': 'Electrolyte blood/urine concentrations', 'timeFrame': '4 weeks'}, {'measure': 'Renin-angiotensin system: plasma renin/aldosterone levels)', 'timeFrame': '4 weeks'}, {'measure': 'Anti-diuretic hormone (ADH) blood levels', 'timeFrame': '4 weeks'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'up to 18 weeks'}, {'measure': 'Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])', 'timeFrame': '4 weeks'}, {'measure': 'Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril', 'timeFrame': '4 weeks'}, {'measure': 'High density lipoprotein-cholesterol (HDL-C) blood levels', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female patients, 18 to 65 years of age, inclusive\n* Diabetes mellitus Type 2, diagnosed at least 3 months before screening\n* Treated with stable dose of metformin for at least 4 weeks prior to screening\n* Treated with stable dose of Angiotensin-converting enzyme inhibitor (ACEI) for at least 4 weeks prior to screening\n* Body mass index (BMI) 18 to 38 kg/m2, inclusive\n\nExclusion Criteria:\n\n* Positive for HIV-1, HIV-2, hepatitis B or hepatitis C infection\n* Pregnant or lactating females\n* Type 1 diabetes or secondary from of diabetes\n* History or evidence of proliferative diabetic retinopathy or clinically significant neuropathy\n* Clinically significant hepatic disease\n* Clinically significant renal impairment\n* History or evidence of clinically significant cardio-vascular disease or disorder\n* Acute infection or current malignancy requiring treatment except for excised basal cell carcinoma'}, 'identificationModule': {'nctId': 'NCT01398267', 'briefTitle': 'A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Aleglitazar 150 µg in Type 2 Diabetic Patients Treated With Lisinopril 20 mg on Renal Function, the Renin-angiotensin System and the Pharmacokinetics of Lisinopril', 'orgStudyIdInfo': {'id': 'BP25328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: aleglitazar', 'Drug: lisinopril']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: lisinopril', 'Drug: placebo']}], 'interventions': [{'name': 'aleglitazar', 'type': 'DRUG', 'description': '150 mcg orally daily, 4 weeks (Day 15 to Day 43)', 'armGroupLabels': ['1']}, {'name': 'lisinopril', 'type': 'DRUG', 'description': '20 mg orally daily, 6 weeks (Day 1 to Day 43)', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}