Diabetes Mellitus, Type 2NCT06113341
A Research Study in Italy to Understand How the Dose Check App Used With Xultophy® Works in the Treatment of People Living With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 19 sites in Italy.
Trial summary
This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- IDegLira
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 19 sitesItaly
- Study dates
- 7 Nov 2024to 2 Mar 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of participants diagnosed with T2DM greater than or equal to (>=) 12 weeks and aged >=21 years at the time of signing informed consent.
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, age above or equal to 21 years at the time of signing informed consent.
- Diagnosed with T2DM >=12 weeks prior to signing consent.
- The decision to initiate treatment with commercially available Dose Check app as a part of treatment along with Xultophy® as per the local label has been made by the patient and the treating physician before and independently from the decision to include the participant in this study.
- Participants who are insulin naive (including the following situations: i. already on treatment with Xultophy® at V1 for less than or equal to (<=) 12 months and for <= 15 dose steps and ii. short-term insulin use for acute illness for a total of <14 days)
- Available HbA1c value <=12 weeks prior to the 'Informed consent and initiation of Dose Check app visit' (V1) or HbA1c measurement taken in relation with the 'Informed consent and initiation of Dose Check app visit' (V1), if in line with local clinical practice.
- Willingness to continue using the Dose Check app on a compatible smartphone according to the intended use for the entire duration of the study.
Who cannot join
- Previous participation in this study. Participation is defined as having signed informed consent in this study.
- Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
- Treatment with any investigational drug or software as a medical device (SaMD) within 30 days prior to enrolment into the study.
- Diagnosed with type 1 diabetes mellitus.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Hypersensitivity to the active substance or any of the excipients as specified in the Xultophy® local label.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Azienda Ospedaliera Ospedale Policlinico Consorziale
Bari, 70120
Azienda Ospedaliera Cannizzaro
Catania, Sicily, 95126
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, 88100
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, 88100
Ospedale di Chivasso
Chivasso, 10034
Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea
Cittadella, 35013
Ospedale Santa Croce
Fano, 61032
Azienda Ospedaliero Universitario Policlinico "G. Martino"
Gazi, ME, 98124
Presidio Ospedaliero Santa Barbara
Iglesias, 09016
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, 37024
Ospedale San Francesco d'Assisi
Oliveto Citra, 84020
ARNAS Ospedali Civico Di Cristina Benfratelli
Palermo, 90127
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
Pisa, 56124
Nuovo Ospedale degli Infermi
Ponderano, 13875
DIABETOLOGIA Ravenna AUSL della Romagna
Ravenna, 48121
AUSL Reggio Emilia
Reggio Emilia, 42123
A.O.U. Policlinico Umberto I
Roma, 00161
Fondazione Univ. Policlinico A.Gemelli
Roma, 00168
About this study
Official title: A Multi-centre, Prospective, Single-arm, Non-interventional Study Describing the Use of the Dose Check App in People Living With Type 2 Diabetes Mellitus and Treated With IDegLira in a Real-world Setting in Italy
This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Participants will also be prescribed to use Dose Check app by study doctor. Participants will be asked to install the Dose Check app in their mobile phone, which will be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.
- 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
Pre-filled pen injection.
| Study group | Role | What they receive |
|---|---|---|
| IDegLira + Dose Check | Participants will be treated with commercially available Xultophy® (IDegLira) used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician. Receives: Drug: IDegLira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant downloaded and actively used the app (Yes/No)
Measured as count of participants.
Measured: From baseline (week 0) to end of the study (EOS) visit (week 26)
Secondary outcomes (6)
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) points.
Measured: From baseline (week 0) to EOS visit (week 26)
Participants reaching individual HbA1c target set by physician
Measured as count of participants (yes/no).
Measured: At EOS visit (week 26)
Participants reaching physician set individual fasting blood glucose (FBG) target
Measured as count of participants (yes/no).
Measured: From baseline (week 0) to EOS visit (week 26)
Time to physician set individual FBG target from first reported FBG
Measured in number of weeks.
Measured: From baseline (week 0) to EOS visit (week 26)
Participants achieving target level FBG according to clinical guidance
Measured as count of participants (yes/no).
Measured: From baseline (week 0) to EOS visit (week 26)
Change in laboratory measured FPG
Measured in milligrams per deciliter (mg/dL).
Measured: From baseline (week 0) to EOS visit (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start7 Nov 2024 (estimated)
- Primary completion23 Feb 2025 (estimated)
- Study completion2 Mar 2026 (estimated)
Why it stopped: The study has been cancelled due to the study's rejection from the local Italian ethics Committee
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
- NCT06113341
- Sponsor's protocol ID
- NN9068-7589
- Other IDs
- U1111-1288-8131
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2023
- Last updated
- 1 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Single-arm, Non-interventional Study Describing the Use of the Dose Check App in People Living With Type 2 Diabetes Mellitus and Treated With IDegLira in a Real-world Setting in Italy
- ClinicalTrials.gov ID
- NCT06113341
- Acronym / sponsor ID
- NN9068-7589
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study has been cancelled due to the study's rejection from the local Italian ethics Committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2024 (estimated)
- Primary completion
- 23 Feb 2025 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 2 Nov 2023 (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.
This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Participants will also be prescribed to use Dose Check app by study doctor. Participants will be asked to install the Dose Check app in their mobile phone, which will be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDegLira + Dose Check | – | Drug: IDegLiraParticipants will be treated with commercially available Xultophy® (IDegLira) used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of participants diagnosed with T2DM greater than or equal to (>=) 12 weeks and aged >=21 years at the time of signing informed consent.
Key inclusion criteria (7 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, age above or equal to 21 years at the time of signing informed consent.
- Diagnosed with T2DM >=12 weeks prior to signing consent.
- The decision to initiate treatment with commercially available Dose Check app as a part of treatment along with Xultophy® as per the local label has been made by the patient and the treating physician before and independently from the decision to include the participant in this study.
- Participants who are insulin naive (including the following situations: i. already on treatment with Xultophy® at V1 for less than or equal to (<=) 12 months and for <= 15 dose steps and ii. short-term insulin use for acute illness for a total of <14 days)
Key exclusion criteria (6 listed)
- Previous participation in this study. Participation is defined as having signed informed consent in this study.
- Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
- Treatment with any investigational drug or software as a medical device (SaMD) within 30 days prior to enrolment into the study.
- Diagnosed with type 1 diabetes mellitus.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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: XultophyPre-filled pen injection. | Drug | IDegLira + Dose Check |
Primary outcome
Participant downloaded and actively used the app (Yes/No)
Time frame: From baseline (week 0) to end of the study (EOS) visit (week 26)
Measured as count of participants.
6 secondary outcomes
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to EOS visit (week 26)
Participants reaching individual HbA1c target set by physician
Time frame: At EOS visit (week 26)
Participants reaching physician set individual fasting blood glucose (FBG) target
Time frame: From baseline (week 0) to EOS visit (week 26)
Time to physician set individual FBG target from first reported FBG
Time frame: From baseline (week 0) to EOS visit (week 26)
Participants achieving target level FBG according to clinical guidance
Time frame: From baseline (week 0) to EOS visit (week 26)
Change in laboratory measured FPG
Time frame: From baseline (week 0) to EOS visit (week 26)
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 Oct 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes Mellitus, Type 2
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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
19 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 19 sites in Italy.
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 7 inclusion and 6 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. 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 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?
Participant downloaded and actively used the app (Yes/No) (time frame: From baseline (week 0) to end of the study (EOS) visit (week 26)). 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 Oct 2024.