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

NCT03823339 | Completed

• 2 other identifiers: NN9068-4458U1111-1213-4338
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)

  Measured in % point

  From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)

Secondary Outcomes (8)

• Patients reached HbA1c less than 7% at end of study (Yes/No )

  At the end of study visit (26-34 weeks)

• 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)

• Average dose step of Xultophy® at end of the study

  At the end of study (26-34 weeks)

• Change of body weight

  From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)

• 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)

Study Arms (1)

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®

Drug: Insulin degludec/liraglutide

Interventions

Insulin degludec/liraglutide 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.

Patients with type 2 diabetes (T2DM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Type 2 Diabetes

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Novo Nordisk Investigational Site

Abu Dhabi, United Arab Emirates

Location

Novo Nordisk Investigational Site

Ajman, 4184, United Arab Emirates

Location

Novo Nordisk Investigational Site

Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

IDegLira

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 30, 2019
• Study Start: January 29, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

AE (3)