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
Completed
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Registration Number
- NCT05607160
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice
Secondary objective:
- Treatment satisfaction
- Detailed Description
Study duration per participant is expected to be approximately 24 weeks
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants achieving the HbA1c target value 6 months 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
- Secondary Outcome Measures
Name Time Method 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 change in treatment satisfaction total score, from baseline to month 6 Baseline to month 6 Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
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 Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6 Baseline to month 6 The GDS was measured using the GDS-4 item questionnaire
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 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 Absolute change in Diabetes-related quality of life total score, from baseline to month 6 Baseline to month 6 The diabetes-related quality of life was measured using the ELDERLY questionnaire
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 participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6 Baseline to month 3 and 6
Trial Locations
- Locations (1)
Investigational site
🇩🇪Germany, Germany