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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
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sex: All
Ages: 75 Years – N/A
Enrollment: 286
Sponsor: Sanofi
Location: Germany
Summary
Primary objective:- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practiceSecondary objective:- Treatment satisfaction
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 formsGlycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%Inadequate glycaemic control (HbA1c), defined by the treating physicianAbility and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third partiesSigned consent formExclusion Criteria:Type 1 diabetes mellitusAge <75 yearsContraindications to insulin glargine 300 U/mlShort-acting insulin in medicationCurrent participation in clinical researchLife expectancy <1 yearKnown alcohol or drug abuseMini Mental State Examination Score ≤19The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Source: ClinicalTrials.gov (NCT05607160). StuddyBuddy aggregates publicly available trial information.