Clinical trial

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

Name

NN9068-4884

Description

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 arms

Trial start

2022-03-22

Estimated PCD

2022-07-15

Trial end

2022-07-15

Status

Completed

Treatment

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

Arms:

IDegLira

Size

175

Primary endpoint

Change in local laboratory measured Glycated Haemoglobin A1c (HbA1c)

From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 175, 'type': 'ACTUAL'}}

Updated at

2022-11-09

1 organization

1 product

2 indications

Organization

Product

Indication

Indication