INTENSIFY: A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Change in laboratory measured glycosylated haemoglobin A1c (HbA1c) [From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)]
Measured in % point
Secondary Outcome Measures
- Patients reached HbA1c less than 7% at end of study (Yes/No ) [At the end of study visit (26-34 weeks)]
Number of patients who achieved/not achieved HbA1c at end of study: <7.0%
- Change in laboratory measured fasting plasma glucose (FPG) [From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)]
Measured in mg/dL
- Average dose step of Xultophy® at end of the study [At the end of study (26-34 weeks)]
Measured in dose steps/day
- Change of body weight [From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)]
Measured in kg
- Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection [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
- Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection [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
- Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall) [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
- Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable [At the end of study (26-34 weeks)]
Pre-specified response option(s)
Eligibility Criteria
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.
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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.
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Previous participation in this study. Participation is defined as having given informed consent in this study.
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Female who is known pregnant, breast-feeding or intends to become pregnant.
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Treated with Xultophy® previously.
-
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | AbuDhabi | United Arab Emirates | ||
| 2 | Novo Nordisk Investigational Site | Ajman | United Arab Emirates | 4184 | |
| 3 | Novo Nordisk Investigational Site | Dubai | United Arab Emirates |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9068-4458
- U1111-1213-4338