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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
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

NCT05607160

CompletedN/A

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus (T2DM)

Countries: Germany

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

Eligibility overview

Sex: ALL

Age: 75 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (1)
  • Germany, Germany