ELDERLY-T: 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
Study Details
Study Description
Brief Summary
Primary objective:
- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice
Secondary objective:
- Treatment satisfaction
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
Study duration per participant is expected to be approximately 24 weeks
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Type 2 diabetes patients >= 75 years |
Outcome Measures
Primary Outcome Measures
- Proportion of participants achieving the HbA1c target value [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 Outcome Measures
- Absolute change in treatment satisfaction total score, from baseline to month 6 [Baseline to month 6]
Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
- Absolute change in Diabetes-related quality of life total score, from baseline to month 6 [Baseline to month 6]
The diabetes-related quality of life was measured using the ELDERLY questionnaire
- Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6 [Baseline to month 6]
The GDS was measured using the GDS-4 item questionnaire
- 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]
Eligibility Criteria
Criteria
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
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Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%
-
Inadequate glycaemic control (HbA1c), defined by the treating physician
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational site | Germany | Germany |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OBS16989
- U1111-1280-6373