Clinical trial NCT03823339: A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Type 2 Diabetes

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)
timeFrame: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
Secondary outcomes:
measure: Patients reached HbA1c less than 7% at end of study (Yes/No )
timeFrame: At the end of study visit (26-34 weeks)
measure: Change in laboratory measured fasting plasma glucose (FPG)
timeFrame: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
measure: Average dose step of Xultophy® at end of the study
timeFrame: At the end of study (26-34 weeks)
measure: Change of body weight
timeFrame: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
measure: Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection
timeFrame: 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)
measure: Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection
timeFrame: 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)
measure: Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)
timeFrame: 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)
measure: Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable
timeFrame: At the end of study (26-34 weeks)
Other outcomes:
Locations:
city: AbuDhabi
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Ajman
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: