Diabetes Mellitus, Type 2INTENSIFYNCT03823339
A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin degludec/liraglutide
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- 29 Jan 2019to 14 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Type 2 Diabetes
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Arab Emirates3 sites
Novo Nordisk Investigational Site
Abu Dhabi
Novo Nordisk Investigational Site
Ajman, 4184
Novo Nordisk Investigational Site
Dubai
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin degludec/liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin degludec/liraglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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® Receives: Drug: Insulin degludec/liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)
Measured in % point
Measured: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
Secondary outcomes (8)
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%
Measured: At the end of study visit (26-34 weeks)
Change in laboratory measured fasting plasma glucose (FPG)
Measured in mg/dL
Measured: 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
Measured in dose steps/day
Measured: At the end of study (26-34 weeks)
Change of body weight
Measured in kg
Measured: 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
Number of episodes
Measured: 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
Number of episodes
Measured: 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)
Number of episodes
Measured: 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
Pre-specified response option(s)
Measured: At the end of study (26-34 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start29 Jan 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823339
- Sponsor's protocol ID
- NN9068-4458
- Other IDs
- U1111-1213-4338
- Acronym
- INTENSIFY
- Status last verified
- Sep 2021
- First submitted
- 24 Jan 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03823339
- Acronym / sponsor ID
- INTENSIFY / NN9068-4458
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes (T2DM) | – | Drug: Insulin degludec/liraglutidePatients 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® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Type 2 Diabetes
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin degludec/liraglutidePatients 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. | Drug | Patients with type 2 diabetes (T2DM) |
Primary outcome
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
8 secondary outcomes
Patients reached HbA1c less than 7% at end of study (Yes/No )
Time frame: 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)
Average dose step of Xultophy® at end of the study
Time frame: 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)
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)
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)
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)
Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable
Time frame: At the end of study (26-34 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.