Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-02 @ 8:31 AM
Study NCT ID:
NCT01500850
Status:
UNKNOWN
Last Update Posted:
2011-12-29
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
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': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'C479079', 'term': 'insulin glulisine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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'}, {'id': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-23', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Intact Proinsulin', 'timeFrame': 'Change from baseline at 24 weeks', 'description': 'The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate the changes of weight after 24 weeks of treatment compared to baseline.'}, {'measure': 'hsCRP', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate changes of hsCRP after 24 weeks of treatment compared to baseline.'}, {'measure': 'Adiponectin', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate changes of adiponectin after 24 weeks of treatment compared to baseline.'}, {'measure': 'MMP-9', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate changes of MMP-9 after 24 weeks of treatment compared to baseline.'}, {'measure': 'OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate changes of OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes) after 24 weeks of treatment compared to baseline.'}, {'measure': 'HOMA-IR score', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate changes of HOMA-IR score after 24 weeks of treatment compared to baseline.'}, {'measure': 'HbA1c', 'timeFrame': 'Baseline and after 24 weeks of treatment.', 'description': 'To evaluate changes of HbA1C after 24 weeks of treatment compared to baseline.'}, {'measure': 'Weight', 'timeFrame': 'After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.', 'description': 'To evaluate changes of weight after 12 weeks of treatment compared to baseline and compared to 24 weeks.'}, {'measure': 'hsCRP', 'timeFrame': 'After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.', 'description': 'To evaluate changes of hsCRP after 12 weeks of treatment compared to baseline and compared to 24 weeks.'}, {'measure': 'Adiponectin', 'timeFrame': 'After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.', 'description': 'To evaluate changes of adiponectin after 12 weeks of treatment compared to baseline and compared to 24 weeks.'}, {'measure': 'Fasting intact Proinsulin', 'timeFrame': 'After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.', 'description': 'To evaluate changes of fasting intact proinsulin after 12 weeks of treatment compared to baseline and compared to 24 weeks.'}, {'measure': 'Glucose', 'timeFrame': 'After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.', 'description': 'To evaluate changes of Glucose after 12 weeks of treatment compared to baseline and compared to 24 weeks.'}, {'measure': 'HbA1c', 'timeFrame': 'After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.', 'description': 'To evaluate changes of HbA1c after 12 weeks of treatment compared to baseline and compared to 24 weeks.'}, {'measure': 'Responder rate', 'timeFrame': 'After 24 weeks of treatment compared to baseline.', 'description': 'To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).'}, {'measure': 'Hypoglycemic events.', 'timeFrame': 'Baseline up to 24 weeks.', 'description': 'Hypoglycemic events defined as blood glucose below 63 mg/dl.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes mellitus', 'NPH insulin', 'Insulin Glargine', 'cardiovascular biomarkers', 'hsCRP, adiponectin', 'intact proinsulin', 'cardiovascular risk'], 'conditions': ['Insulin-requiring Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33166419', 'type': 'DERIVED', 'citation': 'Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.', 'detailedDescription': '* Phase IV\n* Indication: Diabetes mellitus Type 2\n* Primary objective:\n\nTo compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period.\n\n\\- Secondary objectives: To evaluate changes in the parameters\n\n* insulin,\n* glucose,\n* intact proinsulin (after a glucose challenge),\n* hsCRP,\n* adiponectin,\n* MMP-9,\n* HbA1c,\n* weight\n\nafter 24 weeks of treatment.\n\nTo investigate the changes of\n\n* glucose,\n* intact proinsulin,\n* hsCRP,\n* adiponectin,\n* HbA1c\n* weight\n\nbetween visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks).\n\nTo investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).\n\n-Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2 (Baseline) and Visit 8 (after 24 week treatment)\n\n-Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of treatment and compared versus baseline assessment.\n\n* Weight\n* hsCRP\n* Adiponectin\n* MMP-9\n* OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks\n* HOMA-IR score\n* HbA1c\n\nAdditionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8:\n\n* Weight\n* hsCRP\n* Adiponectin\n* Fasting intact Proinsulin\n* Glucose\n* HbA1c\n* Safety Variables:\n* Adverse Events\n* Hypoglycaemic events\n\nMedication/Dosage:\n\nInsulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)\n\n-Study Duration: Duration of study participation for one patient is approximately 26 weeks. Overall total duration of the study is approximately 10 months.\n\nDesign:\n\nThis is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Give written informed consent.\n* Patient consents that his/her family physician/diabetologist will be informed of trial participation\n* Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)\n* Experienced in self blood glucose measurement for ≥ 3 months.\n* HbA1c ≤ 9% and \\>6,5%\n* BMI \\> 30 kg/m²\n* Age ≥ 18 years\n* Waist circumference \\> 88 cm (female) and \\> 102 cm (male)\n* NPH insulin treatment plus 1 or 2 OAD (except TZD)\n\nExclusion Criteria:\n\n* History of drug or alcohol abuse within the last five years prior to screening\n* Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures\n* History of severe or multiple allergies\n* Treatment with any other investigational drug within 3 months prior to screening\n* Progressive fatal disease\n* History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \\> 3 times the normal reference range), renal (creatinine \\> 1.3 mg/dl in women and \\>1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator\n* Pregnant or lactating women\n* Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner\n* Treatment with GLP1-analog or Thiazolidinediones (TZD)\n* hsCRP \\> 10 mg/l (by rapid test at screening visit).\n* Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study\n* Type 1 Diabetes mellitus\n* Patients already treated with intensified conventional insulin therapy.'}, 'identificationModule': {'nctId': 'NCT01500850', 'briefTitle': 'Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'ikfe-CRO GmbH'}, 'officialTitle': 'Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.', 'orgStudyIdInfo': {'id': 'Lantu_L_05720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NPH insulin + insulin glulisine', 'description': 'Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.', 'interventionNames': ['Drug: nph insulin', 'Drug: Insulin glulisine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NPH insulin + human insulin', 'description': 'Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.', 'interventionNames': ['Drug: human insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin glargine + insulin glulisine', 'description': 'Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.', 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Insulin glulisine']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin Glargine + Human insulin', 'description': 'Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.', 'interventionNames': ['Drug: human insulin', 'Drug: Insulin Glargine']}], 'interventions': [{'name': 'nph insulin', 'type': 'DRUG', 'otherNames': ['Insuman Basal'], 'description': 'Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.', 'armGroupLabels': ['NPH insulin + insulin glulisine']}, {'name': 'human insulin', 'type': 'DRUG', 'otherNames': ['Insuman Rapid'], 'description': 'Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.\n\nhuman insulin: bolus injections before each main meal', 'armGroupLabels': ['Insulin Glargine + Human insulin', 'NPH insulin + human insulin']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.', 'armGroupLabels': ['Insulin Glargine + Human insulin', 'Insulin glargine + insulin glulisine']}, {'name': 'Insulin glulisine', 'type': 'DRUG', 'otherNames': ['Apidra'], 'description': 'Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.\n\nInsulin glulisine: bolus injections before each main meal', 'armGroupLabels': ['Insulin glargine + insulin glulisine', 'NPH insulin + insulin glulisine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Forst, MD', 'role': 'CONTACT', 'email': 'thomasf@ikfe.de', 'phone': '+49(0) 6131-576 36 -40', 'phoneExt': '16'}, {'name': 'Daniela Sachsenheimer, MD', 'role': 'CONTACT', 'email': 'danielas@ikfe.de', 'phone': '+49(0) 6131-576 36 40', 'phoneExt': '46'}, {'name': 'Daniela Sachsenheimer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephanie Helleberg, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephan Diessel', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'ikfe GmbH', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'centralContacts': [{'name': 'Andreas Pfützner, Professor', 'role': 'CONTACT', 'email': 'andreasp@ikfe.de', 'phone': '00496131-57636-0', 'phoneExt': '20'}, {'name': 'Thomas Forst, Professor', 'role': 'CONTACT', 'email': 'thomasf@ikfe.de', 'phone': '00496131-57636-0', 'phoneExt': '16'}], 'overallOfficials': [{'name': 'Andreas Pfützner, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ikfe GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ikfe-CRO GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IKFE Institute for Clinical Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}