DiabetesPhase 4NCT01486862
Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs
A Phase 4 study testing biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Mexico.
Trial summary
This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs). 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 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2005to Jul 2006
- 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
- Type 2 diabetes mellitus for at least 12 months
- HbA1c between 7.5-14.5% (inclusive) at screening
- Insulin naïve
- An antidiabetic regimen that has been stable for at least 3 months prior to screening
- An antidiabetic regimen that includes a minimum of 2 OADs
Who cannot join
- Use of any insulin preparations within the past 6 months
- Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NovoMix® 30 (Biphasic Insulin Aspart 70/30) Titrate-to-target: An Observational Study of the Efficacy of NovoMix® 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs
This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30
- 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 aspart 30Drug
Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%
Secondary outcomes (3)
Change in HbA1c
Total number of hypoglycemic events
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionJul 2006
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
- 26 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
- NCT01486862
- Sponsor's protocol ID
- BIASP-1673
- Status last verified
- Oct 2023
- First submitted
- 5 Dec 2011
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NovoMix® 30 (Biphasic Insulin Aspart 70/30) Titrate-to-target: An Observational Study of the Efficacy of NovoMix® 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs
- ClinicalTrials.gov ID
- NCT01486862
- Acronym / sponsor ID
- BIASP-1673
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 7 Dec 2011 (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 North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 | Experimental | Drug: biphasic insulin aspart 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus for at least 12 months
- HbA1c between 7.5-14.5% (inclusive) at screening
- Insulin naïve
- An antidiabetic regimen that has been stable for at least 3 months prior to screening
- An antidiabetic regimen that includes a minimum of 2 OADs
Key exclusion criteria (2 listed)
- Use of any insulin preparations within the past 6 months
- Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
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 aspart 30Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks. | Drug | BIAsp 30 |
Primary outcome
Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%
3 secondary outcomes
Change in HbA1c
Total number of hypoglycemic events
Adverse events
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 2 Nov 2023.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Mexico.
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 2 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 2 Nov 2023. 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 Mexico. 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?
Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%. 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 2 Nov 2023.