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

Sanofi82 enrolled

Overview

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

Study duration per participant is expected to be approximately 24 weeks

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Investigational site

Germany, Germany

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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