Status:
COMPLETED
A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03823339
Start Date
January 29 2019
End Date
December 14 2020
Last Update
September 22 2021
Active Locations (3)
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1
Novo Nordisk Investigational Site
Abu Dhabi, United Arab Emirates
2
Novo Nordisk Investigational Site
Ajman, United Arab Emirates, 4184
3
Novo Nordisk Investigational Site
Dubai, United Arab Emirates