Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT00941369
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2009-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
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': 'D000069036', 'term': 'Insulin Glargine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-21', 'studyFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Assessment, Patient treatment satisfaction and Quality-of-Life', 'timeFrame': 'At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)'}], 'secondaryOutcomes': [{'measure': 'Glycaemic parameters assessment', 'timeFrame': 'At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)'}, {'measure': 'Anteropometric data (Weight, waist circumference) assessment', 'timeFrame': 'At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)'}, {'measure': 'Lipid assessment', 'timeFrame': 'At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)'}, {'measure': 'Hypoglycemia assessment', 'timeFrame': 'Throughout the study from starting until the week 48'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, '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.'}, {'pmid': '26055391', 'type': 'DERIVED', 'citation': 'Hermanns N, Kulzer B, Kohlmann T, Jacob S, Landgraf W, Theobald K, Haak T. Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial. Health Qual Life Outcomes. 2015 Jun 9;13:77. doi: 10.1186/s12955-015-0279-4.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).\n\nSecondary Objective:\n\nA comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:\n\n* Glycaemic parameters: 7 blood glucose profiles\n* Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia\n* Change in lipid status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.\n* Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.\n* No pre-treatment with any insulin in the last 3 months before the study.\n* Glycated Haemoglobin A1c (HbA1c) value between \\> or = 7.0 and \\> or = 9.5%\n* Fasting Blood Glucose (FBG) \\> or = 120 mg/dl (6.7 mmol/l).\n* Body mass index \\< 40 kg/m.\n* Ability to read and understand German language.\n* Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.\n* Women of childbearing potential who will take adequate contraceptive protection.\n\nExclusion criteria:\n\n* Patients with type 1 diabetes mellitus.\n* Any history of ketoacidosis.\n* Pregnancy.\n* Prior treatment with insulin.\n* Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.\n* History of drug or alcohol abuse.\n* Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.\n* Following pancreatectomy.\n* Impaired hepatic function.\n* Impaired renal function.\n* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.\n* Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.\n* Inability to attend follow-up visits.\n* Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).\n* Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.\n* Systemic corticoids \\> 7,5 mg prednisolon equivalent or \\<or=7,5 mg prednisolon equivalent for less than 2 months.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00941369', 'briefTitle': 'Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin', 'orgStudyIdInfo': {'id': 'LANTU_L_04079'}, 'secondaryIdInfos': [{'id': '2009-019013-59(EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen', 'interventionNames': ['Drug: Insulin Glargine (HOE901)/NPH Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen', 'interventionNames': ['Drug: Insulin Glargine (HOE901)/NPH Insulin']}], 'interventions': [{'name': 'Insulin Glargine (HOE901)/NPH Insulin', 'type': 'DRUG', 'description': 'Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time\n\nArm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician\n\nThe starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day.\n\nThe dose adjustments will be based on the results of self-monitoring.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Heinz Riederer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}