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 (ELDERLY-T)

Sanofi

Status: Completed

Conditions: Type 2 Diabetes Mellitus (T2DM)

Study type: Observational

Funder types: Industry

Identifiers

NCT05607160

U1111-1280-6373 (Registry Identifier)

OBS16989

Details and patient eligibility

About

Primary objective:

• Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice

Secondary objective:

• Treatment satisfaction

Full description

Study duration per participant is expected to be approximately 24 weeks

Enrollment: 82 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 1 patient group

Cohort 1

Description:

Type 2 diabetes patients \>= 75 years