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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-29

Study Completion Date

2020-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with type 2 diabetes (T2DM)

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®

Insulin degludec/liraglutide

Intervention Type DRUG

Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study.

Interventions

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Insulin degludec/liraglutide

Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No