DiabetesNCT02821052
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®
An observational study of Diabetes, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- insulin degludec/insulin aspart
- How many people
- 1,355 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jul 2016to 24 Nov 2018
- 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: Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
Who may be able to join
- Signed 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 Ryzodeg® 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
- Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg®
- Male or female, no age limitation
Who cannot join
- Patients who are or have previously been treated with Ryzodeg®
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Patients with a history of hypersensitivity to study product components
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.
This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
- Conditions
- Diabetes
- Being tested
- insulin degludec/insulin aspart
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludec/insulin aspartDrug
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| insulin degludec/insulin aspart | 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 AEs (adverse event)
Measured: Year 0-1
Secondary outcomes (4)
Incidence of SADRs (Serious Adverse Drug Reactions)
Measured: Year 0-1
Severe hypoglycaemic episodes
Measured: Year 0-1
Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)
Measured: Year 0-1
Change in Glycosylated haemoglobin A1c (HbA1c)
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 posted1 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion24 Nov 2018
- Study completion24 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,355 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
- NCT02821052
- Sponsor's protocol ID
- NN5401-4152
- Other IDs
- U1111-1149-9518
- Status last verified
- Oct 2019
- First submitted
- 29 Jun 2016
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Katabami T, Eriksen KT, Yamamoto Y, Ishigaki Y. Long-Term Safety and Clinical Outcomes with Insulin Degludec/Insulin Aspart Treatment in Japanese Patients with Diabetes: A Real-World, Prospective, Observational Study. Adv Ther. 2022 Jan;39(1):544-561. doi: 10.1007/s12325-021-01978-2. Epub 2021 Nov 20.
PubMed 34800283
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.
- ClinicalTrials.gov ID
- NCT02821052
- Acronym / sponsor ID
- NN5401-4152
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 24 Nov 2018 (actual)
- Study completion
- 24 Nov 2018 (actual)
- First posted
- 1 Jul 2016 (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 trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin degludec/insulin aspart | – | Drug: insulin degludec/insulin aspart |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
Key inclusion criteria (4 listed)
- Signed 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 Ryzodeg® 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
- Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg®
- Male or female, no age limitation
Key exclusion criteria (4 listed)
- Patients who are or have previously been treated with Ryzodeg®
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Patients with a history of hypersensitivity to study product components
- 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/insulin aspartEnrolled patients will be treated with Ryzodeg® under routine clinical practice. | Drug | insulin degludec/insulin aspart |
Primary outcome
Incidence of AEs (adverse event)
Time frame: Year 0-1
4 secondary outcomes
Incidence of SADRs (Serious Adverse Drug Reactions)
Time frame: Year 0-1
Severe hypoglycaemic episodes
Time frame: Year 0-1
Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)
Time frame: Year 0-1
Change in Glycosylated haemoglobin A1c (HbA1c)
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 15 Oct 2019.
- Derived from this study: PubMed 34800283Katabami T, Eriksen KT, Yamamoto Y, Ishigaki Y. Long-Term Safety and Clinical Outcomes with Insulin Degludec/Insulin Aspart Treatment in Japanese Patients with Diabetes: A Real-World, Prospective, Observational Study. Adv Ther. 2022 Jan;39(1):544-561. doi: 10.1007/s12325-021-01978-2. Epub 2021 Nov 20.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Novo Nordisk A/S at 1 site in Japan.
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 4 inclusion and 4 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 AEs (adverse event) (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?
On the ClinicalTrials.gov record for NCT02821052, which also lists 1 linked publication.
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 15 Oct 2019.