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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1280-6373 | Registry Identifier | ICTRP |
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Primary objective:
- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice
Secondary objective:
- Treatment satisfaction
Study duration per participant is expected to be approximately 24 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Type 2 diabetes patients >= 75 years |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Germany | Germany |
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
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| D004700 | Endocrine System Diseases |