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

NCT05607160 | Completed

• 2 other identifiers: OBS16989U1111-1280-6373
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: \- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice Secondary objective: \- Treatment satisfaction

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

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

  Baseline to month 6

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

  Baseline to month 6

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

  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

Study Arms (1)

Cohort 1

Type 2 diabetes patients \>= 75 years

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational site

Germany, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: October 5, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)