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

Diabetes Mellitus, Type 2 Clinical Trial

— SPIRIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324462
• Other study ID #: NN9068-4884
• Secondary ID: U1111-1266-5484
• Status: Completed
• Start date: March 22, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Colombia	Novo Nordisk Investigational Site	Barranquilla	Atlantico
Colombia	Novo Nordisk Investigational Site	Bogotá	Bogota DC
Colombia	Novo Nordisk Investigational Site	Bucaramanga	Santander
Colombia	Novo Nordisk Investigational Site	Cúcuta	Norte De Santander
Colombia	Novo Nordisk Investigational Site	Medellín	Antioquia
Colombia	Novo Nordisk Investigational Site	Montería	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in absolute body weight	Kilogram (kg)	From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
Secondary	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