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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

— ELDERLY-T  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05607160
• Other study ID #: OBS16989
• Secondary ID: U1111-1280-6373
• Status: Completed
• Start date: October 5, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary objective:

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

Secondary objective:

• Treatment satisfaction

Description:

Study duration per participant is expected to be approximately 24 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Locations

Country	Name	City	State
Germany	Investigational site	Germany

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6		Baseline to month 3 and 6
Secondary	Absolute change in HbA1c (%), from baseline to month 3 and 6		Baseline to month 3 and 6