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OpenTrials
Completed

NCT Number: NCT05324462

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Medellín, Antioquia, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IDegLira

Drug

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

Primary outcomes

  1. Change in local laboratory measured Glycated Haemoglobin A1c (HbA1c)

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

    Percentage point

Secondary outcomes

  1. Change in absolute body weight

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

    Kilogram (kg)

  2. Comparison between the daily dose of basal insulin and IDegLira

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

    Units/day

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: SPIRIT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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