DiabetesNCT03070704
Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
Trial summary
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin degludec/liraglutide
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2017to 16 Aug 2019
- 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: Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
- The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
- Male or female, age at least 18 years at the time of signing the informed consent
- Patients diagnosed with type 2 diabetes mellitus
- Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician
Who cannot join
- Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
- Previous participation in this study. Participation is defined as signed informed consent
- Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
- Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
- Patients who are participating in other studies or clinical trials.
- Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol
About this study
Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin degludec/liraglutide
- Medical subject headings
- Diabetes Mellitus, 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 commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec /liraglutide | Not described Receives: Drug: insulin degludec/liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent Adverse Events (AEs)
Count and % of events
Measured: Year 0-1
Secondary outcomes (9)
Number of Serious Adverse Events (SAEs)
Count and % of events
Measured: Year 0-1
Number of Serious Adverse Drug Reactions (SADRs)
Count and % of events
Measured: Year 0-1
Number of Adverse Drug Reactions (ADRs)
Count and % of events
Measured: Year 0-1
Number of confirmed hypoglycaemic episodes
Count of episodes
Measured: Year 0-1
Change from baseline in the level of glycosylated haemoglobin (HbA1c)
Measured in %
Measured: Year 0, Year 1
Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline
Measured in mg/dl or other equivalent SI units
Measured: Year 0, Year 1
Percentage of patients achieving the target level of HbA1c below 7%
Measured in %
Measured: Year 1
Change in body weight
Measured in kg and/or %
Measured: Year 0, Year 1
Number of patients withdrawn due to ineffective therapy
Count of withdrawals
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start16 Aug 2017 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion16 Aug 2019 (estimated)
Why it stopped: Request for the study waived by Indian Health Authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070704
- Sponsor's protocol ID
- NN9068-4331
- Other IDs
- U1111-1185-0871
- Status last verified
- Aug 2017
- First submitted
- 24 Feb 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India
- ClinicalTrials.gov ID
- NCT03070704
- Acronym / sponsor ID
- NN9068-4331
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Request for the study waived by Indian Health Authorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 16 Aug 2019 (estimated)
- First posted
- 3 Mar 2017 (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.
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec /liraglutide | – | Drug: insulin degludec/liraglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
- The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
- Male or female, age at least 18 years at the time of signing the informed consent
- Patients diagnosed with type 2 diabetes mellitus
- Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
- Previous participation in this study. Participation is defined as signed informed consent
- Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
- Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
- Patients who are participating in other studies or clinical trials.
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 commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician | Drug | Insulin degludec /liraglutide |
Primary outcome
Incidence of treatment emergent Adverse Events (AEs)
Time frame: Year 0-1
Count and % of events
9 secondary outcomes
Number of Serious Adverse Events (SAEs)
Time frame: Year 0-1
Number of Serious Adverse Drug Reactions (SADRs)
Time frame: Year 0-1
Number of Adverse Drug Reactions (ADRs)
Time frame: Year 0-1
Number of confirmed hypoglycaemic episodes
Time frame: Year 0-1
Change from baseline in the level of glycosylated haemoglobin (HbA1c)
Time frame: Year 0, Year 1
Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline
Time frame: Year 0, Year 1
Percentage of patients achieving the target level of HbA1c below 7%
Time frame: Year 1
Change in body weight
Time frame: Year 0, Year 1
Number of patients withdrawn due to ineffective therapy
Time frame: Year 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
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 6 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: withdrawn, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment emergent Adverse Events (AEs) (time frame: Year 0-1). 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 5 Sep 2017.