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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04666987
• Collaborator: (none)
• Enrollment: 338
• Locations: 28
• Anticipated Duration (Months): 25.3
• Patients Per Site: 12.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin degludec and liraglutide (IDegLira)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 338 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 21, 2020
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm

Intervention/Treatment

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

Drug: Insulin degludec and liraglutide (IDegLira); 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in HbA1c [From baseline (V0, month 0) to end of study (V3, 18 ±3 months)]

2. HbA1c levels less than 7% (yes/no) [At end of study (V3, 18 ±3 months)]

   Percentage of patients - yes

3. HbA1c levels less than 7% without hypoglycaemic episodes (yes/no) [At end of study (V3, 18 ±3 months)]

   Percentage of patients - yes

4. Reason for switching to Xultophy® (precoded question list) [At baseline (V0, month 0)]

   Percentage of patients

5. Change in Xultophy® daily dose [From baseline (V0, month 0) to end of study (V3, 18 ±3 months)]

   Dose steps/day

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 [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

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 [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

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 [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

9. 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

10. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Alessandria		Italy	15121
2	Novo Nordisk Investigational Site	Ancona		Italy
3	Novo Nordisk Investigational Site	Arezzo		Italy	52100
4	Novo Nordisk Investigational Site	Bergamo		Italy	24127
5	Novo Nordisk Investigational Site	Brescia		Italy	25123
6	Novo Nordisk Investigational Site	Carrara		Italy	54033
7	Novo Nordisk Investigational Site	Casoria		Italy	80026
8	Novo Nordisk Investigational Site	Catania		Italy	95126
9	Novo Nordisk Investigational Site	Feltre		Italy	32032
10	Novo Nordisk Investigational Site	Foggia		Italy	71122
11	Novo Nordisk Investigational Site	Francavilla Fontana		Italy	72021
12	Novo Nordisk Investigational Site	Genova		Italy
13	Novo Nordisk Investigational Site	Latina		Italy	04100
14	Novo Nordisk Investigational Site	Messina		Italy	98124
15	Novo Nordisk Investigational Site	Napoli		Italy	80059
16	Novo Nordisk Investigational Site	Napoli		Italy	80138
17	Novo Nordisk Investigational Site	Oliveto Citra		Italy	84020
18	Novo Nordisk Investigational Site	Padova		Italy	35128
19	Novo Nordisk Investigational Site	Pavia		Italy	27100
20	Novo Nordisk Investigational Site	Pescara		Italy	65023
21	Novo Nordisk Investigational Site	Pistoia		Italy
22	Novo Nordisk Investigational Site	Praia a Mare		Italy	87028
23	Novo Nordisk Investigational Site	Roma		Italy	00161
24	Novo Nordisk Investigational Site	Roma		Italy
25	Novo Nordisk Investigational Site	Rome		Italy	00168
26	Novo Nordisk Investigational Site	Salerno		Italy	84131
27	Novo Nordisk Investigational Site	San Donà di Piave		Italy
28	Novo Nordisk Investigational Site	Udine		Italy	33100

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04666987
• Other Study ID Numbers: NN9068-4740; U1111-1253-1809
• First Posted: Dec 14, 2020
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Liraglutide; Xultophy

Study Results

No Results Posted as of Aug 17, 2021