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Diabetes Mellitus, Type 2NCT04666987

A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 28 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. 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?
Insulin degludec and liraglutide (IDegLira)
How many people
359 participants
Where
28 sitesItaly
Study dates
21 Oct 2020to 10 Feb 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
  • Adult, Older adult

Study population: Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy.

Who may be able to join

  • Informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol).
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent.
  • Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.
  • The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
  • Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.
  • For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.
  • The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.
  • Available and documented HbA1c measurement no more than 3 months prior to Xultophy® 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, or women planning to become pregnant during the conduct of the study.
  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.
  • Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Italy28 sites

  • A.O. SS Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • INRCA

    Ancona, 60127

  • Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato

    Arezzo, 52100

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • ASST OSpedali Civili ad indirizzo Metabolico Diabetologico

    Brescia, 25123

  • Centro Polispecialistico Asl Toscana Nord Ovest

    Carrara, 54033

  • D.S. 43 Casoria Asl Napoli 2 Nord

    Casoria, 80026

  • H Cannizzaro Malattie endocrine e del ricambio e nutrizione

    Catania, 95126

  • Ospedale S. Maria del Prato

    Feltre, 32032

  • A.O.U. Ospedali Riuniti

    Foggia, 71122

  • Ospedale Camberlingo

    Francavilla Fontana, 72021

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Ospedale Santa Maria Goretti - UOD Diabetologia

    Latina, LT, 04100

  • A.O.U. Policlinico Martino

    Messina, 98124

  • ASL Napoli 3 sud

    Naples, 80059

  • PSP Loreto Crispi

    Naples, 80122

  • Ospedale San Francesco d'Assisi

    Oliveto Citra, 84020

  • Azienda Ospedaliera Padova

    Padova, 35128

  • ICS Maugeri

    Pavia, Pv, 27100

  • AUSL Pescara

    Pescara, 65023

  • Ospedale San Jacopo

    Pistoia, 51100

  • P.O. Praia a Mare ASP Cosenza

    Praia a Mare, 87028

  • Policlinico Umberto I Clinica Medica DH Diabetologia

    Roma, 00161

  • Casa della Salute Antistio

    Roma, 00174

  • Policlinico Universitario AGemelli DH Patologie dell'Obesità

    Rome, 00168

  • A.O.U. San Giovanni di Dio e Ruggi d'Aragona

    Salerno, 84131

  • Ospedale San Donà di Piave

    San Donà di Piave, 30027

  • ASUFC Udine

    Udine, 33100

Other trials in Italy

About this study

Official title: A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.

Being tested
Insulin degludec and liraglutide (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.

  • Insulin degludec and liraglutide (IDegLira)Drug

    Paricipants will be treated with commercially available Xultophy® according to routine clinical practice at the discretion of the treating physician, following approved label in Italy. The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

Study groups in NCT04666987
Study groupRoleWhat they receive
Xultophy®Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy
Receives: Drug: Insulin degludec and liraglutide (IDegLira)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Haemoglobin (HbA1c)

    Percent (%) point

    Baseline is defined as the time of Xultophy® initiation (V0); if the endpoint variable is unavailable at (V0), the most recent value within 3 months prior to Xultophy® initiation will be used.

    (This definition of baseline applies to all outcome measures.)

    Measured: From baseline (V0, month 0) to 6 months after initiation.

Secondary outcomes (10)

  1. Change in HbA1c

    Measured: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

  2. HbA1c levels less than 7% (yes/no)

    Percentage of patients - yes

    Measured: At end of study (V3, 18 ±3 months)

  3. HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)

    Percentage of patients - yes

    Measured: At end of study (V3, 18 ±3 months)

  4. Reason for switching to Xultophy® (precoded question list)

    Percentage of patients

    Measured: At baseline (V0, month 0)

  5. Change in Xultophy® daily dose

    Dose steps/day

    Measured: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

  6. Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection

    Number of episodes

    Measured: Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

  7. Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection

    Number of episodes

    Measured: Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

  8. Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection

    Number of episodes

    Measured: Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

  9. Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)

    Percentage of patients with treatment intensification

    Measured: At end of study (V3, 18 ±3 months)

  10. Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)

    Percentage of patients with treatment simplification

    Measured: At end of study (V3, 18 ±3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start21 Oct 2020
  3. Primary completion30 Dec 2022
  4. Study completion10 Feb 2023

Resources

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
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666987
Sponsor's protocol ID
NN9068-4740
Other IDs
U1111-1253-1809
Status last verified
Apr 2024
First submitted
20 Nov 2020
Last updated
3 Apr 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

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 28 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 8 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: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 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 Glycated Haemoglobin (HbA1c) (time frame: From baseline (V0, month 0) to 6 months after 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 NCT04666987.

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 3 Apr 2024.

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Clinical Trial NCT04666987 | AzTrials