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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IDegLira

Adult patients with T2D who have initiated treatment with IDegLira a minimum of 26 weeks

IDegLira

Intervention Type 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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female, age above or equal to 18 years at the time of data collection.
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

1. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Novo Nordisk Investigational Site

Barranquilla, Atlántico, Colombia

Site Status

Novo Nordisk Investigational Site

Bogotá, Bogota DC, Colombia

Site Status

Novo Nordisk Investigational Site

Montería, Departamento de Córdoba, Colombia

Site Status

Novo Nordisk Investigational Site

Cúcuta, Norte de Santander Department, Colombia

Site Status

Novo Nordisk Investigational Site

Bucaramanga, Santander Department, Colombia

Site Status

Countries

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Colombia

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.

Reference Type DERIVED
PMID: 38717577 (View on PubMed)

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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