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)

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

Primary objective:

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

Secondary objective:

- Treatment satisfaction

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM)

Detailed Description

Study duration per participant is expected to be approximately 24 weeks

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Germany
  • Germany, Germany
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; Type 2 diabetes patients >= 75 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving the HbA1c target value	Proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in treatment satisfaction total score, from baseline to month 6	Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score	Baseline to month 6
Absolute change in Diabetes-related quality of life total score, from baseline to month 6	The diabetes-related quality of life was measured using the ELDERLY questionnaire	Baseline to month 6
Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6	The GDS was measured using the GDS-4 item questionnaire	Baseline to month 6
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		3 months
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		3 months
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		3 months
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		3 months
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		6 months
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		6 months
Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6		Baseline to month 3 and 6
Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6		Baseline to month 3 and 6
Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6		Baseline to month 3 and 6
Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6		Baseline to month 3 and 6
Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6		Baseline to month 3 and 6
Absolute change in HbA1c (%), from baseline to month 3 and 6		Baseline to month 3 and 6

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: OBS16989; U1111-1280-6373 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No