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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: IDegLira

• Registration Number: NCT05324462
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-22
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	Percentage point

Secondary Outcome Measures

Name	Time	Method
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	Units/day
Change in absolute body weight	From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation	Kilogram (kg)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇴 Bucaramanga, Santander, Colombia