Diabetes Mellitus, Type 2SPIRITNCT05324462
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
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- IDegLira
- How many people
- 175 participants
- Where
- 6 sitesColombia
- Study dates
- 22 Mar 2022to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of male or female adults (above or equal to 18 years at the time of data collection) who are diagnosed with T2D for at least 12 months prior to data collection and were previously treated with basal insulin plus/minus OADs prior to initiating IDegLira. The HbA1c measurement below or equal to 12 weeks prior to IDegLira initiation should be available and documented for each patient to be eligible in the study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Colombia6 sites
Novo Nordisk Investigational Site
Barranquilla, Atlántico
Novo Nordisk Investigational Site
Bogotá, Bogota DC
Novo Nordisk Investigational Site
Bucaramanga, Santander Department
Novo Nordisk Investigational Site
Cúcuta, Norte de Santander Department
Novo Nordisk Investigational Site
Medellín, Antioquia
Novo Nordisk Investigational Site
Montería, Departamento de Córdoba
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- IDegLira
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDegLiraDrug
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
| Study group | Role | What they receive |
|---|---|---|
| IDegLira | Adult patients with T2D who have initiated treatment with IDegLira a minimum of 26 weeks Receives: Drug: IDegLira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local laboratory measured Glycated Haemoglobin A1c (HbA1c)
Percentage point
Measured: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
Secondary outcomes (2)
Change in absolute body weight
Kilogram (kg)
Measured: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
Comparison between the daily dose of basal insulin and IDegLira
Units/day
Measured: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start22 Mar 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324462
- Sponsor's protocol ID
- NN9068-4884
- Other IDs
- U1111-1266-5484
- Acronym
- SPIRIT
- Status last verified
- Nov 2022
- First submitted
- 4 Apr 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Publications
Ramirez-Rincon A, Henao-Carrillo D, Omeara M, Oliveros J, Assaf J, Ordonez JE, Prasad P, Alzate MA. SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia. Diabetes Ther. 2024 Jul;15(7):1535-1545. doi: 10.1007/s13300-024-01593-8. Epub 2024 May 8.
PubMed 38717577
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05324462
- Acronym / sponsor ID
- SPIRIT / NN9068-4884
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDegLira | – | Drug: IDegLiraAdult patients with T2D who have initiated treatment with IDegLira a minimum of 26 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male or female adults (above or equal to 18 years at the time of data collection) who are diagnosed with T2D for at least 12 months prior to data collection and were previously treated with basal insulin plus/minus OADs prior to initiating IDegLira. The HbA1c measurement below or equal to 12 weeks prior to IDegLira initiation should be available and documented for each patient to be eligible in the study
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDegLiraCollecting 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 | Drug | IDegLira |
Primary outcome
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
2 secondary outcomes
Change in absolute body weight
Time frame: From baseline (week 0) to end of study (week 26 plus/minus 6 weeks) after IDegLira initiation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 38717577Ramirez-Rincon A, Henao-Carrillo D, Omeara M, Oliveros J, Assaf J, Ordonez JE, Prasad P, Alzate MA. SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia. Diabetes Ther. 2024 Jul;15(7):1535-1545. doi: 10.1007/s13300-024-01593-8. Epub 2024 May 8.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.