Glycaemic Control and Other Clinical Parameters in Adult Type 2 Diabetes Patients on Basal Insulin Initiating Treatment With IDegLira in Routine Clinical Practice in Colombia
NCT ID: NCT05324462
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
175 participants
OBSERVATIONAL
2022-03-22
2022-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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IDegLira
Adult patients with T2D who have initiated treatment with IDegLira a minimum of 26 weeks
IDegLira
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
Interventions
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IDegLira
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
Eligibility Criteria
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Inclusion Criteria
2. Patient diagnosed with T2D greater than or equal to 12 months prior to data collection.
3. The decision to initiate treatment with commercially available IDegLira has been made by the patient and the treating physician before, which is independent from the decision to participate in this study.
4. Treated with basal insulin plus/minus OADs prior to initiating IDegLira.
5. Available and documented HbA1c measurement below or equal to 12 weeks prior to IDegLira initiation.
Exclusion Criteria
2. Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.
3. Women known to be pregnant or breastfeeding during the conduct of the study.
4. Patients with basal-bolus insulin prior to IDegLira initiation.
5. Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to initiating IDegLira.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Medellín, Antioquia, Colombia
Novo Nordisk Investigational Site
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
Countries
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References
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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.
Other Identifiers
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U1111-1266-5484
Identifier Type: OTHER
Identifier Source: secondary_id
NN9068-4884
Identifier Type: -
Identifier Source: org_study_id
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