NCT05607160Completed
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: 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
Source: ClinicalTrials.gov · Last updated 12 Apr 2024
Brief summary (registry, in English)
Primary objective: \- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice Secondary objective: \- Treatment satisfaction
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 82 (actual)
- First submitted
- 31 Oct 2022
- Start date
- 5 Oct 2022
- Primary completion date
- 11 Dec 2023
- Lead sponsor
- Sanofi
- Diseases
- Type 2 diabetes
- NCT number
- NCT05607160
What you commit to
- Study type: Observational
- Participants enrolled: 82
- From 5 Oct 2022 to the primary completion date, 11 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Short-acting insulin in medication
- Known alcohol or drug abuse
Other illness
- Type 1 diabetes mellitus
Age
- Age \<75 years
Other
- Contraindications to insulin glargine 300 U/ml
- Current participation in clinical research
- Life expectancy \<1 year
- 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.
Who the study is looking for
- 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
Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Germany | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.