Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 6:00 AM
Study NCT ID:
NCT05607160
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'targetDuration': '24 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants achieving the HbA1c target value', 'timeFrame': '6 months', 'description': 'Proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml'}], 'secondaryOutcomes': [{'measure': 'Absolute change in treatment satisfaction total score, from baseline to month 6', 'timeFrame': 'Baseline to month 6', 'description': 'Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score'}, {'measure': 'Absolute change in Diabetes-related quality of life total score, from baseline to month 6', 'timeFrame': 'Baseline to month 6', 'description': 'The diabetes-related quality of life was measured using the ELDERLY questionnaire'}, {'measure': 'Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6', 'timeFrame': 'Baseline to month 6', 'description': 'The GDS was measured using the GDS-4 item questionnaire'}, {'measure': 'Absolute proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml', 'timeFrame': '3 months'}, {'measure': 'Relative proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml', 'timeFrame': '3 months'}, {'measure': 'Absolute proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml', 'timeFrame': '3 months'}, {'measure': 'Relative proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml', 'timeFrame': '3 months'}, {'measure': 'Absolute proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml', 'timeFrame': '6 months'}, {'measure': 'Relative proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml', 'timeFrame': '6 months'}, {'measure': 'Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6', 'timeFrame': 'Baseline to month 3 and 6'}, {'measure': 'Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6', 'timeFrame': 'Baseline to month 3 and 6'}, {'measure': 'Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6', 'timeFrame': 'Baseline to month 3 and 6'}, {'measure': 'Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6', 'timeFrame': 'Baseline to month 3 and 6'}, {'measure': 'Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6', 'timeFrame': 'Baseline to month 3 and 6'}, {'measure': 'Absolute change in HbA1c (%), from baseline to month 3 and 6', 'timeFrame': 'Baseline to month 3 and 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n\\- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice\n\nSecondary objective:\n\n\\- Treatment satisfaction', 'detailedDescription': 'Study duration per participant is expected to be approximately 24 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetes patients 75 years or older, for whom the treating physician has decided to initiate or switch to a therapy with insulin glargin 300 U/ml as part of the routine clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (T2DM) with oral antidiabetic drug (OAD) ± Glucagon-like-peptide-1 receptor agonist (GLP-1-RA) ± basal insulin (other than insulin glargine 300 U/ml)\n* Age ≥75 years incl. patients from outpatient and inpatient care forms\n* Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%\n* Inadequate glycaemic control (HbA1c), defined by the treating physician\n* Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties\n* Signed consent form\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Age \\<75 years\n* Contraindications to insulin glargine 300 U/ml\n* Short-acting insulin in medication\n* Current participation in clinical research\n* Life expectancy \\<1 year\n* Known alcohol or drug abuse\n* Mini Mental State Examination Score ≤19\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT05607160', 'acronym': 'ELDERLY-T', 'briefTitle': 'A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'ELDERLY-T: A Non-interventional, Multicentre, Prospective Observational Study on the Effectiveness and Safety of Insulin Glargine 300 U/ml in Elderly Patients ≥75 Years of Age With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'OBS16989'}, 'secondaryIdInfos': [{'id': 'U1111-1280-6373', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Type 2 diabetes patients \\>= 75 years'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Germany', 'country': 'Germany', 'facility': 'Investigational site'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}