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

Study Overview
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Brief Summary
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Primary objective: - Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice Secondary objective: - Treatment satisfaction

Detailed Description
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Study duration per participant is expected to be approximately 24 weeks

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Age ≥75 years incl. patients from outpatient and inpatient care forms Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0% Inadequate glycaemic control (HbA1c), defined by the treating physician Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties Signed consent form Exclusion Criteria: Type 1 diabetes mellitus Age <75 years Contraindications to insulin glargine 300 U/ml Short-acting insulin in medication Current participation in clinical research Life expectancy <1 year Known alcohol or drug abuse Mini Mental State Examination Score ≤19 The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Type 2 diabetes patients >= 75 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving the HbA1c target value | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in treatment satisfaction total score, from baseline to month 6 | Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score | Baseline to month 6 | 
| Absolute change in Diabetes-related quality of life total score, from baseline to month 6 | The diabetes-related quality of life was measured using the ELDERLY questionnaire | Baseline to month 6 | 
| Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6 | The GDS was measured using the GDS-4 item questionnaire | Baseline to month 6 | 
| 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 |  | 3 months | 
| 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 |  | 3 months | 
| 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 |  | 3 months | 
| 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 |  | 3 months | 
| 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 |  | 6 months | 
| 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 |  | 6 months | 
| Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6 |  | Baseline to month 3 and 6 | 
| Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6 |  | Baseline to month 3 and 6 | 
| Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6 |  | Baseline to month 3 and 6 | 
| Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6 |  | Baseline to month 3 and 6 | 
| Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6 |  | Baseline to month 3 and 6 | 
| Absolute change in HbA1c (%), from baseline to month 3 and 6 |  | Baseline to month 3 and 6 |