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SPIRIT: 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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05324462
Collaborator
(none)
231
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
231 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Apr 8, 2022
Anticipated Primary Completion Date :
Apr 8, 2022
Anticipated Study Completion Date :
Apr 8, 2022

Arms and Interventions

Arm Intervention/Treatment
IDegLira

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

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

    Units/day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT05324462
Other Study ID Numbers:
  • NN9068-4884
  • U1111-1266-5484
First Posted:
Apr 12, 2022
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Xultophy

Study Results

No Results Posted as of Apr 12, 2022