Diabetes Mellitus, Type 2B SimpleNCT03862690
A Research Study, Looking at How NovoMix® Works in People With Type 2 Diabetes in Local Clinical Practice in Algeria
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Algeria.
Trial summary
The purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BIAsp 30
- How many people
- 0 participants
- Where
- 2 sitesAlgeria
- Study dates
- 28 May 2020to 28 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with type 2 diabetes mellitus, previously treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to the study,
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 NovoMix® 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- Male or female, greater than or equal to 19 years at the time of signing informed consent
- Diagnosed with type 2 diabetes and treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to informed consent
- Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of NovoMix® 30 treatment
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any clinical trial of an approved or non- approved investigational medicinal product within 24 weeks prior to initiation of NovoMix® 30 treatment. Clinical trials do not include non-interventional studies
- Hypersensitivity to NovoMix® 30 or to any of the excipients
- Pregnancy or intention of becoming pregnant
Trial locations and contacts
2 sites in 1 country.
Algeria2 sites
Novo Nordisk Investigational Site
Algiers, P.C. 16000, Hydra
Novo Nordisk Investigational Site
Constantine, 25000
About this study
Official title: A Prospective Non-interventional Study Investigating the Treatment Effect of NovoMix® 30 (Biphasic Insulin Aspart 30) in a Real World Adult Population With Type 2 Diabetes in Algeria
The purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their study doctor's appointment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BIAsp 30
- 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.
BIAsp 30Drug
Also called NovoMix®
Participants will receive commercially available BIAsp 30 once daily (QD), twice daily (BID) or thrice daily (TID) for 24 weeks according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose. The decision to switch the patient to NovoMix® 30 is at the treating physician's discretion and independent from the decision to include the patient in the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Type 2 Diabetes Mellitus | A broad adult population of patients with type 2 diabetes (T2D) requiring insulin therapy in different basal-bolus treatment regimens. Receives: Drug: BIAsp 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated haemoglobin A1c (HbA1c)
Measured in % point.
Measured: From baseline (week 0) to end of study (week 24)
Secondary outcomes (7)
Participants achieving HbA1c below 7.0%
Number of participants achieving HbA1c less than 7.0% at end of study (week 24) (yes/no).
Measured: At end of study (week 24)
Particpants achieving HbA1c below 7.5%
Number of participants achieving HbA1c less than 7.5% at end of study (week 24) (yes/no).
Measured: At end of study (week 24)
Partcipants achieving HbA1c below 8.0%
Number of participants achieving HbA1c less than 8.0% at end of study (week 24) (yes/no).
Measured: At end of study (week 24)
Change in rate of severe hypoglycaemia
Measured in episodes/person-year.
Measured: From baseline (week 0) to end of study visit (as recalled at week 24)
Change in total insulin dose
Measured in units/day.
Measured: From baseline (week 0) to end of study (week 24)
Change in Diabetes Treatment Satisfaction (DTSQ) score
The DTSQs is a self-completion questionnaire used to assess subject's treatment satisfaction. The DTSQ total score will be based on item 1 and 4-8, which are scored on a scale from 0 to 36, a higher score related to a better perception of treatment satisfaction. Items 2 and 3 will be reported separately on a scale from 0 to 6 as per instruction in the DTSQs manual.
Measured: From baseline (week 0) to end of study (week 24)
Change in health-related quality of life (EQ-5D)
The EQ-5D questionnaire will be used to assess subject's health-related quality of life. This instrument contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and measures 5 levels of severity (no problems, slight problems, moderate problems, severe problems and extreme problems). The EQ visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical VAS with scores 0-100.
Measured: From baseline (week 0) to end of study (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start28 May 2020 (estimated)
- Primary completion28 Jun 2021 (estimated)
- Study completion28 Jun 2021 (estimated)
Why it stopped: Sponsor decision
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862690
- Sponsor's protocol ID
- BIASP-4439
- Other IDs
- U1111-1208-5168
- Acronym
- B Simple
- Status last verified
- Jul 2020
- First submitted
- 25 Feb 2019
- Last updated
- 20 Jul 2020
- 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 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Study Investigating the Treatment Effect of NovoMix® 30 (Biphasic Insulin Aspart 30) in a Real World Adult Population With Type 2 Diabetes in Algeria
- ClinicalTrials.gov ID
- NCT03862690
- Acronym / sponsor ID
- B Simple / BIASP-4439
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (estimated)
- Primary completion
- 28 Jun 2021 (estimated)
- Study completion
- 28 Jun 2021 (estimated)
- First posted
- 5 Mar 2019 (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 purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their study doctor's appointment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Type 2 Diabetes Mellitus | – | Drug: BIAsp 30A broad adult population of patients with type 2 diabetes (T2D) requiring insulin therapy in different basal-bolus treatment regimens. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with type 2 diabetes mellitus, previously treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to the study,
Key inclusion criteria (5 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 NovoMix® 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- Male or female, greater than or equal to 19 years at the time of signing informed consent
- Diagnosed with type 2 diabetes and treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to informed consent
- Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of NovoMix® 30 treatment
Key exclusion criteria (5 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any clinical trial of an approved or non- approved investigational medicinal product within 24 weeks prior to initiation of NovoMix® 30 treatment. Clinical trials do not include non-interventional studies
- Hypersensitivity to NovoMix® 30 or to any of the excipients
- Pregnancy or intention of becoming pregnant
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 |
|---|---|---|
| BIAsp 30Also: NovoMix®Participants will receive commercially available BIAsp 30 once daily (QD), twice daily (BID) or thrice daily (TID) for 24 weeks according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose. The decision to switch the patient to NovoMix® 30 is at the treating physician's discretion and independent from the decision to include the patient in the study. | Drug | Participants with Type 2 Diabetes Mellitus |
Primary outcome
Change in glycosylated haemoglobin A1c (HbA1c)
Time frame: From baseline (week 0) to end of study (week 24)
Measured in % point.
7 secondary outcomes
Participants achieving HbA1c below 7.0%
Time frame: At end of study (week 24)
Particpants achieving HbA1c below 7.5%
Time frame: At end of study (week 24)
Partcipants achieving HbA1c below 8.0%
Time frame: At end of study (week 24)
Change in rate of severe hypoglycaemia
Time frame: From baseline (week 0) to end of study visit (as recalled at week 24)
Change in total insulin dose
Time frame: From baseline (week 0) to end of study (week 24)
Change in Diabetes Treatment Satisfaction (DTSQ) score
Time frame: From baseline (week 0) to end of study (week 24)
Change in health-related quality of life (EQ-5D)
Time frame: From baseline (week 0) to end of study (week 24)
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 20 Jul 2020.
- 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 Reporting Anchor and Disclosure 1452 study director
Novo Nordisk A/S
2 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 Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Algeria.
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 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: withdrawn, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Algeria. 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 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?
Change in glycosylated haemoglobin A1c (HbA1c) (time frame: From baseline (week 0) to end of study (week 24)). 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 20 Jul 2020.