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

NCT06113341 | Withdrawn

• 2 other identifiers: NN9068-7589U1111-1288-8131
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 19

Brief 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®. 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

Outcome Measures

Primary Outcomes (1)

• Participant downloaded and actively used the app (Yes/No)

  Measured as count of participants.

  From baseline (week 0) to end of the study (EOS) visit (week 26)

Secondary Outcomes (6)

• Change in glycated haemoglobin (HbA1c)

  From baseline (week 0) to EOS visit (week 26)

• Participants reaching individual HbA1c target set by physician

  At EOS visit (week 26)

• Participants reaching physician set individual fasting blood glucose (FBG) target

  From baseline (week 0) to EOS visit (week 26)

• Time to physician set individual FBG target from first reported FBG

  From baseline (week 0) to EOS visit (week 26)

• Participants achieving target level FBG according to clinical guidance

  From baseline (week 0) to EOS visit (week 26)

Study Arms (1)

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.

Drug: IDegLira

Interventions

IDegLira DRUG

Pre-filled pen injection.

Also known as: Xultophy

IDegLira + Dose Check

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (19)

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, Cz, 88100, Italy

Location

Azienda Ospedaliero Universitario Policlinico "G. Martino"

Gazi, ME, 98124, Italy

Location

Azienda Ospedaliera Cannizzaro

Catania, Sicily, 95126, Italy

Location

A.O. SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Azienda Ospedaliera Ospedale Policlinico Consorziale

Bari, 70120, Italy

Location

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, 88100, Italy

Location

Ospedale di Chivasso

Chivasso, 10034, Italy

Location

Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea

Cittadella, 35013, Italy

Location

Ospedale Santa Croce

Fano, 61032, Italy

Location

Presidio Ospedaliero Santa Barbara

Iglesias, 09016, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, 37024, Italy

Location

Ospedale San Francesco d'Assisi

Oliveto Citra, 84020, Italy

Location

ARNAS Ospedali Civico Di Cristina Benfratelli

Palermo, 90127, Italy

Location

Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello

Pisa, 56124, Italy

Location

Nuovo Ospedale degli Infermi

Ponderano, 13875, Italy

Location

DIABETOLOGIA Ravenna AUSL della Romagna

Ravenna, 48121, Italy

Location

AUSL Reggio Emilia

Reggio Emilia, 42123, Italy

Location

A.O.U. Policlinico Umberto I

Roma, 00161, Italy

Location

Fondazione Univ. Policlinico A.Gemelli

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

IDegLira; Xultophy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 7, 2024
• Primary Completion: February 23, 2025
• Study Completion: March 2, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (19)