DiabetesPhase 4NCT01704378
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes
A Phase 4 study testing biphasic insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 17 sites in 4 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 18 Apr 2001to 14 Mar 2003
- Phase
- Phase 4
- 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
Who may be able to join
- Signed informed consent obtained before any trial-related activities
- Completed the trial BIAsp-1236
Who cannot join
- Planned changes in use of any prescription medication that may interfere with glucose regulation
- Known or suspected allergy to trial products or related products
- Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
- Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United Kingdom6 sites
Novo Nordisk Investigational Site
Derby, DE7 1DY
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Hull, HU3 2JZ
Novo Nordisk Investigational Site
Liverpool, L7 8XP
Novo Nordisk Investigational Site
Scarborough, YO12 6QL
Novo Nordisk Investigational Site
Wirral, Merseyside, CH63 4JY
Norway5 sites
Novo Nordisk Investigational Site
Gjøvik, NO-2819
Novo Nordisk Investigational Site
Horten, NO-3188
Novo Nordisk Investigational Site
Kirkenær, 2260
Novo Nordisk Investigational Site
Kongsvinger, 2212
Novo Nordisk Investigational Site
Notodden, NO-3675
Finland3 sites
Novo Nordisk Investigational Site
Kotka, 48210
Novo Nordisk Investigational Site
Kuopio, 70210
Novo Nordisk Investigational Site
Lahti, 15850
Sweden3 sites
Novo Nordisk Investigational Site
Falun, 791 82
Novo Nordisk Investigational Site
Helsingborg, 254 43
Novo Nordisk Investigational Site
Motala, 591 85
About this study
Official title: A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphasic insulin aspartDrug
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal
| Study group | Role | What they receive |
|---|---|---|
| BIAsp | Experimental | Not described Receives: Drug: biphasic insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hypoglycaemic episodes
Occurrence of adverse events
Secondary outcomes (3)
HbA1c (glycosylated haemoglobin)
Prandial increment in blood glucose
7-point blood glucose profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study start18 Apr 2001
- Primary completion14 Mar 2003
- Study completion14 Mar 2003
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 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
- NCT01704378
- Sponsor's protocol ID
- BIASP-1386
- Status last verified
- Feb 2017
- First submitted
- 8 Oct 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
- ClinicalTrials.gov ID
- NCT01704378
- Acronym / sponsor ID
- BIASP-1386
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2001 (actual)
- Primary completion
- 14 Mar 2003 (actual)
- Study completion
- 14 Mar 2003 (actual)
- First posted
- 11 Oct 2012 (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 Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIAsp | Experimental | Drug: biphasic insulin aspart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent obtained before any trial-related activities
- Completed the trial BIAsp-1236
Key exclusion criteria (4 listed)
- Planned changes in use of any prescription medication that may interfere with glucose regulation
- Known or suspected allergy to trial products or related products
- Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
- Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
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 |
|---|---|---|
| biphasic insulin aspartIndividually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal | Drug | BIAsp |
Primary outcome
Number of Hypoglycaemic episodes
Occurrence of adverse events
3 secondary outcomes
HbA1c (glycosylated haemoglobin)
Prandial increment in blood glucose
7-point blood glucose profile
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 24 Feb 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
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biphasic insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 17 sites in 4 countries.
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 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Norway, Finland, Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Hypoglycaemic episodes. The study lists 2 primary outcomes in all. 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 24 Feb 2017.