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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-5484 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to investigate the glycaemic control and other clinical parameters in adult patients previously treated with basal insulin (with or without OADs) and switched to IDegLira in real-world clinical practice in Colombia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegLira | Adult patients with T2D who have initiated treatment with IDegLira a minimum of 26 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDegLira | Drug | Collecting data reported in medical records of patients with T2D, who had initiated treatment with commercially available IDegLira according to the routine clinical practice and local label at the discretion of the treating physician |
| Measure | Description | Time Frame |
|---|---|---|
| Change in local laboratory measured Glycated Haemoglobin A1c (HbA1c) | Percentage point | From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in absolute body weight | Kilogram (kg) | From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation |
| Comparison between the daily dose of basal insulin and IDegLira |
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Inclusion criteria:
Exclusion criteria:
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The study population will consist of male or female adults (above or equal to 18 years at the time of data collection) who are diagnosed with T2D for at least 12 months prior to data collection and were previously treated with basal insulin plus/minus OADs prior to initiating IDegLira. The HbA1c measurement below or equal to 12 weeks prior to IDegLira initiation should be available and documented for each patient to be eligible in the study
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Medellín | Antioquia | Colombia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38717577 | Derived | Ramirez-Rincon A, Henao-Carrillo D, Omeara M, Oliveros J, Assaf J, Ordonez JE, Prasad P, Alzate MA. SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia. Diabetes Ther. 2024 Jul;15(7):1535-1545. doi: 10.1007/s13300-024-01593-8. Epub 2024 May 8. |
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"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Units/day
| From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation |
| Barranquilla |
| Atlántico |
| Colombia |
| Novo Nordisk Investigational Site | Bogotá | Bogota DC | Colombia |
| Novo Nordisk Investigational Site | Montería | Departamento de Córdoba | Colombia |
| Novo Nordisk Investigational Site | Cúcuta | Norte de Santander Department | Colombia |
| Novo Nordisk Investigational Site | Bucaramanga | Santander Department | Colombia |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
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