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OpenTrials
Completed

NCT Number: 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

Primary objective:

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

Secondary objective:

- Treatment satisfaction

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site

Germany

About this study

Study duration per participant is expected to be approximately 24 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of participants achieving the HbA1c target value

    Time frame: 6 months

    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

Secondary outcomes

  1. Absolute change in treatment satisfaction total score, from baseline to month 6

    Time frame: Baseline to month 6

    Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score

  2. Absolute change in Diabetes-related quality of life total score, from baseline to month 6

    Time frame: Baseline to month 6

    The diabetes-related quality of life was measured using the ELDERLY questionnaire

  3. Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6

    Time frame: Baseline to month 6

    The GDS was measured using the GDS-4 item questionnaire

  4. 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

    Time frame: 3 months

  5. 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

    Time frame: 3 months

  6. 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

    Time frame: 3 months

  7. 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

    Time frame: 3 months

  8. 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

    Time frame: 6 months

  9. 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

    Time frame: 6 months

  10. Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6

    Time frame: Baseline to month 3 and 6

  11. Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6

    Time frame: Baseline to month 3 and 6

  12. Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6

    Time frame: Baseline to month 3 and 6

  13. Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6

    Time frame: Baseline to month 3 and 6

  14. Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6

    Time frame: Baseline to month 3 and 6

  15. Absolute change in HbA1c (%), from baseline to month 3 and 6

    Time frame: Baseline to month 3 and 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: ELDERLY-T

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2022
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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