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

September 21, 2021 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • AbuDhabi, United Arab Emirates
        • Novo Nordisk Investigational Site
      • Ajman, United Arab Emirates, 4184
        • Novo Nordisk Investigational Site
      • Dubai, United Arab Emirates
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with Type 2 Diabetes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
At the end of study visit (26-34 weeks)
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
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
Time Frame: At the end of study (26-34 weeks)
Measured in dose steps/day
At the end of study (26-34 weeks)
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
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
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
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)
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
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)
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
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)
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)
At the end of study (26-34 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2019

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

December 14, 2020

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9068-4458
  • U1111-1213-4338 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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