Diabetes Mellitus, Type 2GLIDENCT05479591
A Research Study Looking at Blood Sugar Control in People With Type 2 Diabetes Previously Treated With Premix Insulin and Initiating Treatment With Insulin Degludec/Liraglutide (IDegLira) in Local Clinical Practice in Croatia
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
Trial summary
The purpose of this study is to look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2022to 30 Apr 2023
- 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: Participants with Type 2 Diabetes.
Who may be able to join
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female patients aged greater than or equal to (>=) 18 years at the time of signing informed consent.
- Patients diagnosed with T2D and receiving treatment with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines.
- Switched to treatment with IDegLira from previous treatment of premix insulins. The decision to initiate treatment with IDegLira must be independently from the decision to enrol in the study.
- Available and documented HbA1c collected within 12 weeks prior to initiation of IDegLira.
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Participation in any other T2D clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to initiation of IDegLira.
- Previous treatment with IDegLira.
- Patients diagnosed with Type 1 diabetes mellitus.
- Female who is known to be pregnant, breastfeeding or intends to become pregnant during the conduct of the study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the IDegLira label in Croatia.
About this study
Official title: Glycaemic Control and Management in Adult Type 2 Diabetes Patients Previously Treated With Premix Insulins and Initiating Treatment With IDegLira in Routine Clinical Practice in Croatia: A 36-week Single Arm, Prospective, Multi-centre, Non-interventional Study
The purpose of this study is to look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. Decision to initiate treatment with IDegLira will be made by study doctor independent from the study. The study will last for about 36 weeks. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
- 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
Also called Xultophy
Participants will be treated with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia and independent from the decision to include the participant in the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with type 2 diabetes (T2D) | Participants with T2D previously treated with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines will initiate treatment with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia. Receives: Drug: IDegLira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin A1c (HbA1c)
Measured in percentage (%) point.
Measured: From baseline to end of study (week 36 ± 6 weeks)
Secondary outcomes (4)
Number of participants with HbA1c less than (<) 7.0%
Number of participants having Yes/No.
Measured: At end of study (week 36 ± 6 weeks)
Starting dose of IDegLira
Measured in dose steps/day.
Measured: At baseline
Dose of IDegLira at end of study
Measured in dose steps/day.
Measured: At end of study (week 36 ± 6 weeks)
Change in body weight
Measured in kilograms (kg).
Measured: From baseline to end of study (week 36 ± 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 0 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
- NCT05479591
- Sponsor's protocol ID
- NN9068-4972
- Other IDs
- U1111-1271-8967
- Acronym
- GLIDE
- Status last verified
- Oct 2022
- First submitted
- 27 Jul 2022
- Last updated
- 1 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Control and Management in Adult Type 2 Diabetes Patients Previously Treated With Premix Insulins and Initiating Treatment With IDegLira in Routine Clinical Practice in Croatia: A 36-week Single Arm, Prospective, Multi-centre, Non-interventional Study
- ClinicalTrials.gov ID
- NCT05479591
- Acronym / sponsor ID
- GLIDE / NN9068-4972
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 29 Jul 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 look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. Decision to initiate treatment with IDegLira will be made by study doctor independent from the study. The study will last for about 36 weeks. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with type 2 diabetes (T2D) | – | Drug: IDegLiraParticipants with T2D previously treated with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines will initiate treatment with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Type 2 Diabetes.
Key inclusion criteria (5 listed)
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female patients aged greater than or equal to (>=) 18 years at the time of signing informed consent.
- Patients diagnosed with T2D and receiving treatment with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines.
- Switched to treatment with IDegLira from previous treatment of premix insulins. The decision to initiate treatment with IDegLira must be independently from the decision to enrol in the study.
- Available and documented HbA1c collected within 12 weeks prior to initiation of IDegLira.
Key exclusion criteria (7 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Participation in any other T2D clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to initiation of IDegLira.
- Previous treatment with IDegLira.
- Patients diagnosed with Type 1 diabetes mellitus.
- Female who is known to be pregnant, breastfeeding or intends to become pregnant during the conduct of the study.
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 |
|---|---|---|
| IDegLiraAlso: XultophyParticipants will be treated with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia and independent from the decision to include the participant in the study. | Drug | Participants with type 2 diabetes (T2D) |
Primary outcome
Change in Glycated Haemoglobin A1c (HbA1c)
Time frame: From baseline to end of study (week 36 ± 6 weeks)
Measured in percentage (%) point.
4 secondary outcomes
Number of participants with HbA1c less than (<) 7.0%
Time frame: At end of study (week 36 ± 6 weeks)
Starting dose of IDegLira
Time frame: At baseline
Dose of IDegLira at end of study
Time frame: At end of study (week 36 ± 6 weeks)
Change in body weight
Time frame: From baseline to end of study (week 36 ± 6 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
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 7 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Glycated Haemoglobin A1c (HbA1c) (time frame: From baseline to end of study (week 36 ± 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.