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

Diabetes Mellitus, Type 2 Clinical Trial

— INTENSIFY  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823339
• Other study ID #: NN9068-4458
• Secondary ID: U1111-1213-4338
• Status: Completed
• Start date: January 29, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: September 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United Arab Emirates	Novo Nordisk Investigational Site	AbuDhabi
United Arab Emirates	Novo Nordisk Investigational Site	Ajman
United Arab Emirates	Novo Nordisk Investigational Site	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

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