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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

175

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

March 22, 2022

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed

Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

April 4, 2022

Last Update Submit

November 4, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Change in absolute body weight
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
From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation

Study Arms (1)

IDegLira

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

Drug: IDegLira

Interventions

IDegLiraDRUG

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

IDegLira

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.