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

Study Overview
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: IDegLira


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female, age above or equal to 18 years at the time of data collection. Patient diagnosed with T2D greater than or equal to 12 months prior to data collection. 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. Treated with basal insulin plus/minus OADs prior to initiating IDegLira. Available and documented HbA1c measurement below or equal to 12 weeks prior to IDegLira initiation. Exclusion criteria: Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 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. Women known to be pregnant or breastfeeding during the conduct of the study. Patients with basal-bolus insulin prior to IDegLira initiation. Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to initiating IDegLira.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IDegLira<br>Adult patients with T2D who have initiated treatment with IDegLira a minimum of 26 weeks | Drug: IDegLira<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Units/day | From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation |