A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates (INTENSIFY)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin degludec/liraglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT03823339

NN9068-4458

U1111-1213-4338 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to collect information on how Xultophy® works in patients with type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26-34 weeks. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study.
• Male or female, age greater than or equal to 18 years at the time of signing informed consent.
• Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1).
• Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of Xultophy® treatment.

Exclusion criteria

• Hypersensitivity to the active substance or to any of the excipients as specified in the Xultophy® local label.
• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Female who is known pregnant, breast-feeding or intends to become pregnant.
• Treated with Xultophy® previously.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial design

300 participants in 1 patient group

Patients with type 2 diabetes (T2DM)

Description:

Patients with T2DM treated with any basal insulin or glucagon-Like peptide-1 receptor agonist (GLP-1 RA) (including once weekly GLP-1 RA) with/without oral antidiabetic drug (OAD) treatment, and with inadequate glycaemic control, for whom the physician had decided to intensify their treatment with Xultophy®

Treatment:

Drug: Insulin degludec/liraglutide