DiabetesNCT02230618
Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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 35 sites in India.
Trial summary
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy 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/insulin aspart
- How many people
- 1,029 participants
- Where
- 35 sitesIndia
- Study dates
- 24 Nov 2015to 1 Jun 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 where the treating physician has decided to start Ryzodeg™ according to routine clinical practice will qualify for starting treatment with Ryzodeg™.
Who may be able to join
- Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
- Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician
Who cannot join
- Known or suspected allergy to Ryzodeg™ any of the active substances 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 Ryzodeg™ 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
35 sites in 1 country.
35 sites in 1 country
India35 sites
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380007
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380052
Novo Nordisk Investigational Site
Ahmedabad, Gujarat
Novo Nordisk Investigational Site
Amritsar, Punjab
Novo Nordisk Investigational Site
Angamaly, Kerala
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560092
Novo Nordisk Investigational Site
Bangalore, Karnataka
Novo Nordisk Investigational Site
Bilāspur, 495001
Novo Nordisk Investigational Site
Chandigarh, Punjab
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600037
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600100
Novo Nordisk Investigational Site
Chennai, Tamil Nadu
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641009
Novo Nordisk Investigational Site
Gandhinagar, Gujarat, 382428
Novo Nordisk Investigational Site
Ghuma, Gujarat
Novo Nordisk Investigational Site
Guntur, Andhra Pradesh, 522001
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, 452008
Novo Nordisk Investigational Site
Indore, Madhya Pradesh
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302017
Novo Nordisk Investigational Site
Jaipur, Rajasthan
Novo Nordisk Investigational Site
Kochi, Kerala, 682041
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700054
Novo Nordisk Investigational Site
Lucknow, Uttar Pradesh, 226005
Novo Nordisk Investigational Site
Lucknow, Uttar Pradesh
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, 625 020
Novo Nordisk Investigational Site
Mangalore, Karnataka, 575001
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400053
Novo Nordisk Investigational Site
Noida, Uttar Pradesh, 201301
Novo Nordisk Investigational Site
Pune, Maharashtra, 411001
Novo Nordisk Investigational Site
Surat, Gujarat, 395002
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032
Novo Nordisk Investigational Site
Thrissur, Kerala
Novo Nordisk Investigational Site
Trivandrum, Kerala
Novo Nordisk Investigational Site
Vijayawada, Andhra Pradesh, 520002
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, 530002
About this study
Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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 this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.
- Being tested
- insulin degludec/insulin aspart
- 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 degludec/insulin aspartDrug
Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.
| Study group | Role | What they receive |
|---|---|---|
| Ryzodeg™ | Not described Receives: Drug: insulin degludec/insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Weeks 0-52
Secondary outcomes (8)
Serious Adverse Events (SAEs)
Measured: Weeks 0-52
Serious Adverse Drug Reactions (SADRs)
Measured: Weeks 0-52
Adverse Drug Reactions (ADRs)
Measured: Weeks 0-52
Severe or Blood glucose (BG) Confirmed hypoglycaemia
Measured: Weeks 0-52
Change in HbA1c (glycosylated haemoglobin)
Measured: Week 0, week 52
Change in Fasting Plasma Glucose (FPG)
Measured: Week 0, week 52
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
Measured: Week 0, week 52
The reason for initiating or intensifying treatment with Ryzodeg™
Measured: Week 0 - week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start24 Nov 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 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
- 1,029 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
- NCT02230618
- Sponsor's protocol ID
- NN5401-4149
- Other IDs
- U1111-1157-0615, ENCEPP/SDPP/6587
- Status last verified
- Mar 2018
- First submitted
- 29 Aug 2014
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. 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 Ryzodeg™ (Insulin Degludec/Insulin Aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
- ClinicalTrials.gov ID
- NCT02230618
- Acronym / sponsor ID
- NN5401-4149
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 3 Sep 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 this study is to evaluate long term safety and efficacy 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 |
|---|---|---|
| Ryzodeg™ | – | Drug: insulin degludec/insulin aspart |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes where the treating physician has decided to start Ryzodeg™ according to routine clinical practice will qualify for starting treatment with Ryzodeg™.
Key inclusion criteria (2 listed)
- Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
- Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician
Key exclusion criteria (6 listed)
- Known or suspected allergy to Ryzodeg™ any of the active substances 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 Ryzodeg™ 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 degludec/insulin aspartRyzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given. | Drug | Ryzodeg™ |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Weeks 0-52
8 secondary outcomes
Serious Adverse Events (SAEs)
Time frame: Weeks 0-52
Serious Adverse Drug Reactions (SADRs)
Time frame: Weeks 0-52
Adverse Drug Reactions (ADRs)
Time frame: Weeks 0-52
Severe or Blood glucose (BG) Confirmed hypoglycaemia
Time frame: Weeks 0-52
Change in HbA1c (glycosylated haemoglobin)
Time frame: Week 0, week 52
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 52
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
Time frame: Week 0, week 52
The reason for initiating or intensifying treatment with Ryzodeg™
Time frame: Week 0 - week 52
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 13 Mar 2018.
- 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
35 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 35 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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) (time frame: Weeks 0-52). 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 13 Mar 2018.