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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin degludec/liraglutide

• Registration Number: NCT03823339
• Lead Sponsor: Novo Nordisk A/S

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-24
• Study Start: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes (T2DM)	Insulin degludec/liraglutide	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®

Primary Outcome Measures

Name	Time	Method
Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)	From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)	Measured in % point

Secondary Outcome Measures

Name	Time	Method
Patients reached HbA1c less than 7% at end of study (Yes/No )	At the end of study visit (26-34 weeks)	Number of patients who achieved/not achieved HbA1c at end of study: \<7.0%
Change in laboratory measured fasting plasma glucose (FPG)	From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)	Measured in mg/dL
Average dose step of Xultophy® at end of the study	At the end of study (26-34 weeks)	Measured in dose steps/day
Change of body weight	From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)	Measured in kg
Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection	Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)	Number of episodes
Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection	Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)	Number of episodes
Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)	Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks)	Number of episodes
Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable	At the end of study (26-34 weeks)	Pre-specified response option(s)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇪 Dubai, United Arab Emirates