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
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Insulin degludec and liraglutide (IDegLira)
- Registration Number
- NCT04666987
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 359
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Xultophy® Insulin degludec and liraglutide (IDegLira) Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) From baseline (V0, month 0) to 6 months after initiation. 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.)
- Secondary Outcome Measures
Name Time Method Reason for switching to Xultophy® (precoded question list) At baseline (V0, month 0) Percentage of patients
HbA1c levels less than 7% (yes/no) At end of study (V3, 18 ±3 months) Percentage of patients - yes
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 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 Number of episodes
Change in Xultophy® daily dose From baseline (V0, month 0) to end of study (V3, 18 ±3 months) Dose steps/day
Change in HbA1c From baseline (V0, month 0) to end of study (V3, 18 ±3 months) HbA1c levels less than 7% without hypoglycaemic episodes (yes/no) At end of study (V3, 18 ±3 months) Percentage of patients - yes
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 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 Number of episodes
Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no) At end of study (V3, 18 ±3 months) Percentage of patients with treatment simplification
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 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 Number of episodes
Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no) At end of study (V3, 18 ±3 months) Percentage of patients with treatment intensification
Trial Locations
- Locations (28)
A.O. SS Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Ospedale Camberlingo
🇮🇹Francavilla Fontana, Italy
Ospedale Santa Maria Goretti - UOD Diabetologia
🇮🇹Latina, LT, Italy
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
ASST OSpedali Civili ad indirizzo Metabolico Diabetologico
🇮🇹Brescia, Italy
D.S. 43 Casoria Asl Napoli 2 Nord
🇮🇹Casoria, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
INRCA
🇮🇹Ancona, Italy
Policlinico Umberto I Clinica Medica DH Diabetologia
🇮🇹Roma, Italy
Casa della Salute Antistio
🇮🇹Roma, Italy
Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
🇮🇹Arezzo, Italy
Centro Polispecialistico Asl Toscana Nord Ovest
🇮🇹Carrara, Italy
H Cannizzaro Malattie endocrine e del ricambio e nutrizione
🇮🇹Catania, Italy
P.O. Praia a Mare ASP Cosenza
🇮🇹Praia a Mare, Italy
Ospedale San Donà di Piave
🇮🇹San Donà di Piave, Italy
ICS Maugeri
🇮🇹Pavia, Pv, Italy
ASL Napoli 3 sud
🇮🇹Napoli, Italy
Ospedale San Francesco d'Assisi
🇮🇹Oliveto Citra, Italy
Azienda Ospedaliera Padova
🇮🇹Padova, Italy
Ospedale S. Maria del Prato
🇮🇹Feltre, Italy
A.O.U. Policlinico Martino
🇮🇹Messina, Italy
PSP Loreto Crispi
🇮🇹Napoli, Italy
Ospedale San Jacopo
🇮🇹Pistoia, Italy
Policlinico Universitario AGemelli DH Patologie dell'Obesità
🇮🇹Rome, Italy
A.O.U. San Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
A.O.U. Ospedali Riuniti
🇮🇹Foggia, Italy
AUSL Pescara
🇮🇹Pescara, Italy
ASUFC Udine
🇮🇹Udine, Italy