Clinical trial NCT05324462: 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
Official title: 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 - A Single-arm, Non-interventional Retrospective Chart Review Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in local laboratory measured Glycated Haemoglobin A1c (HbA1c)
timeFrame: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
Secondary outcomes:
measure: Change in absolute body weight
timeFrame: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
measure: Comparison between the daily dose of basal insulin and IDegLira
timeFrame: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Novo Nordisk Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Novo Nordisk Investigational Site
state: Atlantico
city: Bogotá
country: Colombia
facility: Novo Nordisk Investigational Site
state: Bogota DC
city: Montería
country: Colombia
facility: Novo Nordisk Investigational Site
state: Cordoba
city: Cúcuta
country: Colombia
facility: Novo Nordisk Investigational Site
state: Norte De Santander
city: Bucaramanga
country: Colombia
facility: Novo Nordisk Investigational Site
state: Santander
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: