Clinical trial NCT05607160: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 82
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants achieving the HbA1c target value
timeFrame: 6 months
Secondary outcomes:
measure: Absolute change in treatment satisfaction total score, from baseline to month 6
timeFrame: Baseline to month 6
measure: Absolute change in Diabetes-related quality of life total score, from baseline to month 6
timeFrame: Baseline to month 6
measure: Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6
timeFrame: Baseline to month 6
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
Other outcomes:
Locations:
city: Germany
country: Germany
facility: Investigational site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: