DiabetesNCT02117622
A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 38 sites in India.
Trial summary
This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin degludec
- How many people
- 1,056 participants
- Where
- 38 sitesIndia
- Study dates
- 24 Jul 2015to 5 Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes mellitus requiring insulin therapy who qualify for starting treatment with Tresiba® based on the clinical judgment by their treating physician during enrolment period.
Who may be able to join
- Informed consent obtained before any study-related activities (Study related activities are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data
- Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician
Who cannot join
- Known or suspected allergy to Tresiba®, the active substance or any of the excipients
- Previous participation in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who are or have previously been on Tresiba® therapy
- Patients who are participating in other studies or clinical trials
- Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
India38 sites
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380007
Novo Nordisk Investigational Site
Ahmedabad, Gujarat
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560092
Novo Nordisk Investigational Site
Bhopal, Madhya Pradesh, 462037
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600037
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600040
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600086
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600100
Novo Nordisk Investigational Site
Chennai, 600008
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641009
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641018
Novo Nordisk Investigational Site
Delhi, New Delhi, 110076
Novo Nordisk Investigational Site
Delhi, New Delhi
Novo Nordisk Investigational Site
Ghuma, Gujarat
Novo Nordisk Investigational Site
Guntur, Andhra Pradesh, 522001
Novo Nordisk Investigational Site
Gurgaon, Haryana
Novo Nordisk Investigational Site
Guwahati, Assam, 781006
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500001
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500004
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500072
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, 452010
Novo Nordisk Investigational Site
Indore, Madhya Pradesh
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700054
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700094
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, 625 020
Novo Nordisk Investigational Site
Mohali, Punjab, 160062
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400053
Novo Nordisk Investigational Site
Nagpur, Maharashtra, 440010
Novo Nordisk Investigational Site
New Delhi, 110088
Novo Nordisk Investigational Site
Noida, Uttar Pradesh, 201301
Novo Nordisk Investigational Site
Noida, Uttar Pradesh
Novo Nordisk Investigational Site
Pune, Maharashtra, 411001
Novo Nordisk Investigational Site
Pune, Maharashtra, 411040
Novo Nordisk Investigational Site
Pune, Maharashtra
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032
Novo Nordisk Investigational Site
Thrissur, Kerala
Novo Nordisk Investigational Site
Vijayawada, Andhra Pradesh, 520002
About this study
Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
- Being tested
- insulin degludec
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludecDrug
Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes mellitus requiring insulin therapy | Not described Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) by preferred term
Measured: During 1 year of treatment
Secondary outcomes (7)
Incidence of serious adverse events (SAEs) by preferred term
Measured: During 1 year of treatment
Incidence of serious adverse drug reactions (SADRs) by preferred term
Measured: During 1 year of treatment
Incidence of adverse drug reactions (ADRs) by preferred term
Measured: During 1 year of treatment
Incidence of severe hypoglycaemia
Measured: During 1 year of treatment
Change from baseline in glycosylated haemoglobin (HbA1c)
Measured: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Change from baseline in fasting plasma glucose (FPG)
Measured: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Incidence of confirmed hypoglycaemia
Measured: During 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start24 Jul 2015
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
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
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117622
- Sponsor's protocol ID
- NN1250-4129
- Other IDs
- U1111-1145-9828, ENCEPP/SDPP/6318
- Status last verified
- Jul 2017
- First submitted
- 16 Apr 2014
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 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 (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
- ClinicalTrials.gov ID
- NCT02117622
- Acronym / sponsor ID
- NN1250-4129
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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 the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes mellitus requiring insulin therapy | – | Drug: insulin degludec |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes mellitus requiring insulin therapy who qualify for starting treatment with Tresiba® based on the clinical judgment by their treating physician during enrolment period.
Key inclusion criteria (2 listed)
- Informed consent obtained before any study-related activities (Study related activities are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data
- Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician
Key exclusion criteria (6 listed)
- Known or suspected allergy to Tresiba®, the active substance or any of the excipients
- Previous participation in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who are or have previously been on Tresiba® therapy
- 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 degludecTreatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study | Drug | Patients with diabetes mellitus requiring insulin therapy |
Primary outcome
Incidence of adverse events (AEs) by preferred term
Time frame: During 1 year of treatment
7 secondary outcomes
Incidence of serious adverse events (SAEs) by preferred term
Time frame: During 1 year of treatment
Incidence of serious adverse drug reactions (SADRs) by preferred term
Time frame: During 1 year of treatment
Incidence of adverse drug reactions (ADRs) by preferred term
Time frame: During 1 year of treatment
Incidence of severe hypoglycaemia
Time frame: During 1 year of treatment
Change from baseline in glycosylated haemoglobin (HbA1c)
Time frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Incidence of confirmed hypoglycaemia
Time frame: During 1 year of treatment
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 2 Aug 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
38 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 and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 38 sites in India.
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 2 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: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in India. 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?
Incidence of adverse events (AEs) by preferred term (time frame: During 1 year of treatment). 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 2 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.