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.
Study Type
OBSERVATIONAL
Enrollment
359
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.
Ospedale Santa Maria Goretti - UOD Diabetologia
Latina, LT, Italy
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.)
Time frame: From baseline (V0, month 0) to 6 months after initiation.
Change in HbA1c
Time frame: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
HbA1c levels less than 7% (yes/no)
Percentage of patients - yes
Time frame: At end of study (V3, 18 ±3 months)
HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)
Percentage of patients - yes
Time frame: At end of study (V3, 18 ±3 months)
Reason for switching to Xultophy® (precoded question list)
Percentage of patients
Time frame: At baseline (V0, month 0)
Change in Xultophy® daily dose
Dose steps/day
Time frame: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
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
Time frame: 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
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ICS Maugeri
Pavia, Pv, Italy
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
INRCA
Ancona, Italy
Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
Arezzo, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
ASST OSpedali Civili ad indirizzo Metabolico Diabetologico
Brescia, Italy
Centro Polispecialistico Asl Toscana Nord Ovest
Carrara, Italy
D.S. 43 Casoria Asl Napoli 2 Nord
Casoria, Italy
H Cannizzaro Malattie endocrine e del ricambio e nutrizione
Catania, Italy
...and 18 more locations
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
Time frame: 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 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
Time frame: 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
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
Time frame: At end of study (V3, 18 ±3 months)
Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)
Percentage of patients with treatment simplification
Time frame: At end of study (V3, 18 ±3 months)