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

September 27, 2024 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • A.O. SS Antonio e Biagio e Cesare Arrigo
      • Bari, Italy, 70120
        • Azienda Ospedaliera Ospedale Policlinico Consorziale
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
      • Chivasso, Italy, 10034
        • Ospedale di Chivasso
      • Cittadella, Italy, 35013
        • Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea
      • Fano, Italy, 61032
        • Ospedale Santa Croce
      • Iglesias, Italy, 09016
        • Presidio Ospedaliero Santa Barbara
      • Negrar Di Valpolicella, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria
      • Oliveto Citra, Italy, 84020
        • Ospedale San Francesco d'Assisi
      • Palermo, Italy, 90127
        • ARNAS Ospedali Civico Di Cristina Benfratelli
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
      • Ponderano, Italy, 13875
        • Nuovo Ospedale Degli Infermi
      • Ravenna, Italy, 48121
        • DIABETOLOGIA Ravenna AUSL della Romagna
      • Reggio Emilia, Italy, 42123
        • AUSL Reggio Emilia
      • Roma, Italy, 00161
        • A.O.U. Policlinico Umberto I
      • Roma, Italy, 00168
        • Fondazione Univ. Policlinico A.Gemelli
    • Cz
      • Catanzaro, Cz, Italy, 88100
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
    • ME
      • Gazi, ME, Italy, 98124
        • Azienda Ospedaliero Universitario Policlinico "G. Martino"
    • Sicily
      • Catania, Sicily, Italy, 95126
        • Azienda Ospedaliera Cannizzaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Pre-filled pen injection.
Other Names:
  • Xultophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (week 0) to end of the study (EOS) visit (week 26)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants reaching individual HbA1c target set by physician
Time Frame: At EOS visit (week 26)
Measured as count of participants (yes/no).
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)
Measured as count of participants (yes/no).
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)
Measured in number of weeks.
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)
Measured as count of participants (yes/no).
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)
Measured in milligrams per deciliter (mg/dL).
From baseline (week 0) to EOS visit (week 26)
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to EOS visit (week 26)
Measured as percentage (%) points.
From baseline (week 0) to EOS visit (week 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 7, 2024

Primary Completion (Estimated)

February 23, 2025

Study Completion (Estimated)

March 2, 2026

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9068-7589
  • U1111-1288-8131 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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