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Completed

NCT Number: NCT04666987

A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the 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

Ospedale Santa Maria Goretti - UOD Diabetologia, Latina, LT, Italy

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Who can participate

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

Inclusion criteria

  • Informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol).
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent.
  • Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.
  • The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
  • Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.
  • For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.
  • The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.
  • Available and documented HbA1c measurement no more than 3 months prior to Xultophy® initiation.

Exclusion criteria

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.
  • Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.
  • Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.

Treatment and study plan

Insulin degludec and liraglutide (IDegLira)

Drug

Paricipants will be treated with commercially available Xultophy® according to routine clinical practice at the discretion of the treating physician, following approved label in Italy. The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

Primary outcomes

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame: From baseline (V0, month 0) to 6 months after initiation.

    Percent (%) point

    Baseline is defined as the time of Xultophy® initiation (V0); if the endpoint variable is unavailable at (V0), the most recent value within 3 months prior to Xultophy® initiation will be used.

    (This definition of baseline applies to all outcome measures.)

Secondary outcomes

  1. Change in HbA1c

    Time frame: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

  2. HbA1c levels less than 7% (yes/no)

    Time frame: At end of study (V3, 18 ±3 months)

    Percentage of patients - yes

  3. HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)

    Time frame: At end of study (V3, 18 ±3 months)

    Percentage of patients - yes

  4. Reason for switching to Xultophy® (precoded question list)

    Time frame: At baseline (V0, month 0)

    Percentage of patients

  5. Change in Xultophy® daily dose

    Time frame: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

    Dose steps/day

  6. Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection

    Time frame: Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

    Number of episodes

  7. Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection

    Time frame: Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

    Number of episodes

  8. Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection

    Time frame: Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

    Number of episodes

  9. Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)

    Time frame: At end of study (V3, 18 ±3 months)

    Percentage of patients with treatment intensification

  10. Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)

    Time frame: At end of study (V3, 18 ±3 months)

    Percentage of patients with treatment simplification

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2020
Registry last updated
Apr 3, 2024

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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