Type 2 Diabetes Mellitus (T2DM)
Conditions
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
Interventions
None listed
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 | — |
| 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 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 | — |
| 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 | — |
Countries
Germany
Outcome results
None listed