Diabetes Mellitus, Type 2NCT04892069
Investigating the Effect of Ryzodeg® in Adult Patients With Type 2 Diabetes in Lebanon
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Lebanon.
Trial summary
The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. 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/Insulin Aspart
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 27 May 2021to 18 Nov 2021
- 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: Participants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age above or equal to 18 years at the time of signing the informed consent.
- Patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
- Patients who were not achieving optimal glycaemic control and who required intensification of antidiabetic treatment and Ryzodeg was the treatment of choice.
- Available and documented HbA1c value at less or equal to 12 weeks prior to initiation of Ryzodeg® treatment and end of study within the study windows.
- Available and documented follow up time of at least 52 weeks with 26 weeks follow-up prior to and after initiation of Ryzodeg®.
- 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.
Who cannot join
- Previous participation in this study. Participation is defined as signed informed consent.
- Participation in any clinical study of an approved or non-approved investigational medicinal product within 26 weeks before and after initiation of treatment with Ryzodeg®.
- Having been previously treated with Ryzodeg® prior to study start.
- Female who were pregnant or breast-feeding during the study.
- 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: A Retrospective, Single Centre, Non-interventional Study Investigating the Effect of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in Lebanon
The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Degludec/Insulin Aspart
- 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/Insulin AspartDrug
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. 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.
| Study group | Role | What they receive |
|---|---|---|
| Ryzodeg® | Participants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon Receives: Drug: Insulin Degludec/Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin (HbA1c)
Percent (%) point. For all primary and secondary outcome measures: Baseline values for effect assessment will be collected as close to and prior to Ryzodeg® initiation as possible (week 0) but none of these values may be more than 12 weeks old. For end of study a window of 6 weeks before and after week 26 is used.
Measured: From baseline (defined as the time of Ryzodeg® initiation (week -12 to week 0)) to end-of-study (week 26 +/- 6 weeks)
Secondary outcomes (6)
HbA1c less than 7%
Percentage of patients
Measured: At end-of-study week 26
HbA1c less than 7% without any severe hypoglycaemic episodes during period 2 (26 weeks after initiation of Ryzodeg®)
Percentage of patients
Measured: At end-of-study week 26
Change in fasting plasma glucose (FPG)
mmol/L
Measured: From baseline to end-of-study week 26
Change in insulin dose (total, basal, prandial)
units/day
Measured: From baseline to end-of-study week 26
Change in body weight
Kilogram (Kg)
Measured: From baseline to end-of-study week 26
Change in the occurrence of severe hypoglycaemic events before and after initiation of treatment
Number of patients experiencing severe hypoglycaemic events in period 1 versus period 2.
Period 1 is defined as 26 weeks prior to initiation of Ryzodeg® and period 2 is defined as 26 weeks after initiation of Ryzodeg®.
Measured: From week -26 to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start27 May 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892069
- Sponsor's protocol ID
- NN5401-4597
- Other IDs
- U1111-1235-6983
- Status last verified
- Nov 2022
- First submitted
- 13 May 2021
- Last updated
- 14 Nov 2022
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single Centre, Non-interventional Study Investigating the Effect of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in Lebanon
- ClinicalTrials.gov ID
- NCT04892069
- Acronym / sponsor ID
- NN5401-4597
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 19 May 2021 (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 study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ryzodeg® | – | Drug: Insulin Degludec/Insulin AspartParticipants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon
Key inclusion criteria (7 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age above or equal to 18 years at the time of signing the informed consent.
- Patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
- Patients who were not achieving optimal glycaemic control and who required intensification of antidiabetic treatment and Ryzodeg was the treatment of choice.
- Available and documented HbA1c value at less or equal to 12 weeks prior to initiation of Ryzodeg® treatment and end of study within the study windows.
Key exclusion criteria (5 listed)
- Previous participation in this study. Participation is defined as signed informed consent.
- Participation in any clinical study of an approved or non-approved investigational medicinal product within 26 weeks before and after initiation of treatment with Ryzodeg®.
- Having been previously treated with Ryzodeg® prior to study start.
- Female who were pregnant or breast-feeding during the study.
- 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 AspartAll patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. 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. | Drug | Ryzodeg® |
Primary outcome
Change in Glycated Haemoglobin (HbA1c)
Time frame: From baseline (defined as the time of Ryzodeg® initiation (week -12 to week 0)) to end-of-study (week 26 +/- 6 weeks)
Percent (%) point. For all primary and secondary outcome measures: Baseline values for effect assessment will be collected as close to and prior to Ryzodeg® initiation as possible (week 0) but none of these values may be more than 12 weeks old. For end of study a window of 6 weeks before and after week 26 is used.
6 secondary outcomes
HbA1c less than 7%
Time frame: At end-of-study week 26
HbA1c less than 7% without any severe hypoglycaemic episodes during period 2 (26 weeks after initiation of Ryzodeg®)
Time frame: At end-of-study week 26
Change in fasting plasma glucose (FPG)
Time frame: From baseline to end-of-study week 26
Change in insulin dose (total, basal, prandial)
Time frame: From baseline to end-of-study week 26
Change in body weight
Time frame: From baseline to end-of-study week 26
Change in the occurrence of severe hypoglycaemic events before and after initiation of treatment
Time frame: From week -26 to week 26
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 14 Nov 2022.
- 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 Transparency (dept. 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 Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Lebanon.
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 7 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 14 Nov 2022. 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 Lebanon. 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 Glycated Haemoglobin (HbA1c) (time frame: From baseline (defined as the time of Ryzodeg® initiation (week -12 to week 0)) to end-of-study (week 26 +/- 6 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 14 Nov 2022.