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Completed

NCT Number: NCT03823339

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Abu Dhabi, United Arab Emirates

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)

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

    Measured in % point

Secondary outcomes

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

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

    Number of patients who achieved/not achieved HbA1c at end of study: <7.0%

  2. Change in laboratory measured fasting plasma glucose (FPG)

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

    Measured in mg/dL

  3. Average dose step of Xultophy® at end of the study

    Time frame: At the end of study (26-34 weeks)

    Measured in dose steps/day

  4. Change of body weight

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

    Measured in kg

  5. Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection

    Time frame: 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

  6. Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection

    Time frame: 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

  7. Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)

    Time frame: 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

  8. Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable

    Time frame: At the end of study (26-34 weeks)

    Pre-specified response option(s)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicenter Prospective Non-interventional Study Investigating the Treatment Effect of Xultophy® Intensification in a Real World Population With Type 2 Diabetes in United Arab Emirates

Acronym: INTENSIFY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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