Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02106104
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], '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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'C057619', 'term': 'glimepiride'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body anthropometrics: body weight, height, body mass index, waist circumference', 'timeFrame': '8 weeks'}, {'measure': 'Body fat content', 'timeFrame': '8 weeks'}, {'measure': 'Systemic hemodynamic variables (blood pressure, heart rate, stroke volume, cardiac output/-index, total systemic vascular resistance)', 'timeFrame': '8 weeks', 'description': 'Derived from non-invasive beat-to-beat finger blood pressure measurements'}, {'measure': 'Cardiac autonomic nervous system function', 'timeFrame': '8 weeks'}, {'measure': 'Microvascular function', 'timeFrame': '8 weeks'}, {'measure': 'Arterial stiffness', 'timeFrame': '8 weeks'}, {'measure': 'Glycemic variables', 'timeFrame': '8 weeks', 'description': 'Glycated hemoglobin (HbA1c) and fasting glucose'}, {'measure': 'Lipid spectrum', 'timeFrame': '8 weeks'}, {'measure': 'DPP4- and ACE activity', 'timeFrame': '8 weeks'}], 'primaryOutcomes': [{'measure': 'Changes from baseline following 8-week treatment with linagliptin vs glimepiride on fasting and postprandial renal hemodynamics, measured as GFR / ERPF (determined by inulin/para-aminohippuric-acid clearance)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Renal tubular function', 'timeFrame': '8 weeks'}, {'measure': 'Renal damage, measured by urine biomarkers', 'timeFrame': '8 weeks'}, {'measure': 'Blood Pressure and Heart Rate', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'Diabetic kidney disease', 'Diabetic nephropathy', 'Renoprotection', 'DPP-4 inhibitors', 'Linagliptin', 'SU derivatives', 'Glimepiride'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '32900785', 'type': 'DERIVED', 'citation': 'Muskiet MHA, Tonneijck L, Smits MM, Kramer MHH, Ouwens DM, Hartmann B, Holst JJ, Touw DJ, Danser AHJ, Joles JA, van Raalte DH. Effects of DPP-4 Inhibitor Linagliptin Versus Sulfonylurea Glimepiride as Add-on to Metformin on Renal Physiology in Overweight Patients With Type 2 Diabetes (RENALIS): A Randomized, Double-Blind Trial. Diabetes Care. 2020 Nov;43(11):2889-2893. doi: 10.2337/dc20-0902. Epub 2020 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4 inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.', 'detailedDescription': 'Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors (DPP-4i), may hold promise in preventing the onset and progression of diabetic kidney disease. However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes.\n\nTherefore, the present study aims to explore the mechanistic and clinical effects of DPP-4i on fasting and postprandial renal physiology and biomarkers in patients with type 2 diabetes.\n\nForty-eight patients with type 2 diabetes will undergo an eight week intervention with linagliptin or glimepiride in order to assess changes in the outcome parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes (HbA1c: 6.5-9.0% DCCT or 48-75 mmol/mol IFCC)\n* Metformin monotherapy; using a stable dose for at least 3 months prior to inclusion\n* Both genders (females must be post-menopausal)\n* Caucasian\n* Age: 35-75 years\n* Body Mass Index: \\>25 kg/m2\n* All patients with previously diagnosed hypertension should use a RAS-interfering agent (angiotensin converting enzyme inhibitor/angiotensin II receptor blocker) for at least 3 months\n\nExclusion Criteria:\n\n* Current / chronic use of the following medication: thiazolidinediones, insulin, glucocorticoids, immune suppressants, antimicrobial agents or chemotherapeutics. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study\n* Chronic use of NSAIDs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications. However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing\n* Pregnancy\n* Frequent occurrence of (confirmed) hypoglycemia (plasma glucose \\<3.9 mmol/L)\n* Estimated Glomerular Filtration Rate \\< 60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)\n* Current urinary tract infection and active nephritis\n* Recent (\\<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke, transient ischemic neurologic disorder\n* Complaints compatible with or established gastroparesis and/or neurogenic bladder\n* Active liver disease\n* History of or actual pancreatic disease\n* History of or actual malignancy (except for basal cell carcinoma)\n* History of or actual severe mental disease\n* Substance abuse (alcohol: defined as \\>4 units/day; smoking/nicotine: defined as daily smoking/use)\n* Allergy to any of the agents used in the study\n* Inability to understand the study protocol or give informed consent'}, 'identificationModule': {'nctId': 'NCT02106104', 'acronym': 'RENALIS', 'briefTitle': 'Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'A Phase 4, Monocenter, Randomized, Double-blind, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Linagliptin Versus the Sulfonylurea (SU) Derivative Glimepiride on Renal Physiology and Biomarkers in Metformin-treated Patients With Type 2 Diabetes Mellitus (T2DM)', 'orgStudyIdInfo': {'id': 'DC2013RENALIS'}, 'secondaryIdInfos': [{'id': 'U1111-1143-9518', 'type': 'OTHER', 'domain': 'Universal Trial Number'}, {'id': '2013-002493-47', 'type': 'EUDRACT_NUMBER'}, {'id': 'NL47157.029.13', 'type': 'REGISTRY', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linagliptin 5 mg QD (N=24)', 'description': 'Linagliptin 5 mg will be taken orally, once daily for 8 weeks', 'interventionNames': ['Drug: Linagliptin 5 mg QD (N=24)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride 1 mg QD (N=24)', 'description': 'Glimepiride 1 mg will be taken orally, once daily for 8 weeks', 'interventionNames': ['Drug: Glimepiride 1 mg QD (N=24)']}], 'interventions': [{'name': 'Linagliptin 5 mg QD (N=24)', 'type': 'DRUG', 'otherNames': ['Trajenta'], 'description': 'Linagliptin 5 mg will be taken orally, once daily for 8 weeks', 'armGroupLabels': ['Linagliptin 5 mg QD (N=24)']}, {'name': 'Glimepiride 1 mg QD (N=24)', 'type': 'DRUG', 'otherNames': ['Amaryl'], 'description': 'Glimepiride 1 mg will be taken orally, once daily for 8 weeks', 'armGroupLabels': ['Glimepiride 1 mg QD (N=24)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Mark Kramer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'M.H.H. Kramer', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}