DiabetesPhase 4NCT00605111
Efficacy and Safety of Biphasic Insulin Aspart 30 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 7 countries.
Trial summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy. 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
- How many people
- 193 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Dec 2003to Oct 2004
- 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 for at least 24 months
- BMI between 18 and 30 kg/m2
- Insulin naive subjects
- OAD treatment with max two OADs alone or combined with other therapy
- HbA1c between 7-12%
Who cannot join
- Type 1 diabetes
- Receipt of any investigational drug within the last three months prior to this trial
- Current or previous treatment with thiazolidiones within the last 6 months
- OAD treatment with three or more OADs within the last 4 months
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Australia5 sites
Novo Nordisk Investigational Site
Blacktown, New South Wales, 2148
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Fitzroy, 3065
Novo Nordisk Investigational Site
Garran, 2605
Novo Nordisk Investigational Site
Stones Corner, 4120
Malaysia3 sites
Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Georgetown, Penang, 10450
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Hong Kong2 sites
Novo Nordisk Investigational Site
Hong Kong Island
Novo Nordisk Investigational Site
Shatin, New Territories
Philippines2 sites
Novo Nordisk Investigational Site
Cebu City, 6000
Novo Nordisk Investigational Site
Quezon City, 1100
Taiwan2 sites
Novo Nordisk Investigational Site
Changhua, 500
Novo Nordisk Investigational Site
Kaoshiung, 807
Thailand2 sites
Novo Nordisk Investigational Site
Bangkok, 10300
Novo Nordisk Investigational Site
Bangkok, 10330
About this study
Official title: Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 11 weeks of treatment
Secondary outcomes (3)
The proportion of subjects achieving treatment target of HbA1c below 7%
Measured: at 11 and 24 weeks
8-point plasma glucose profiles
Measured: performed at 11 and 24 weeks
FPG
Measured: at 11 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startDec 2003
- Primary completionOct 2004
- Study completionOct 2004
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 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
- NCT00605111
- Sponsor's protocol ID
- BIASP-3021
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2008
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bebakar WM, Chow CC, Kadir KA, Suwanwalaikorn S, Vaz JA, Bech OM; BIAsp-3021 study group. Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes. Diabetes Obes Metab. 2007 Sep;9(5):724-32. doi: 10.1111/j.1463-1326.2007.00743.x. Epub 2007 Jun 26.
PubMed 17593237
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy
- ClinicalTrials.gov ID
- NCT00605111
- Acronym / sponsor ID
- BIASP-3021
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 30 Jan 2008 (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 trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 for at least 24 months
- BMI between 18 and 30 kg/m2
- Insulin naive subjects
- OAD treatment with max two OADs alone or combined with other therapy
- HbA1c between 7-12%
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Receipt of any investigational drug within the last three months prior to this trial
- Current or previous treatment with thiazolidiones within the last 6 months
- OAD treatment with three or more OADs within the last 4 months
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 | Drug | – |
Primary outcome
HbA1c
Time frame: after 11 weeks of treatment
3 secondary outcomes
The proportion of subjects achieving treatment target of HbA1c below 7%
Time frame: at 11 and 24 weeks
8-point plasma glucose profiles
Time frame: performed at 11 and 24 weeks
FPG
Time frame: at 11 weeks and 24 weeks
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 11 Jan 2017.
- Results publication: PubMed 17593237Bebakar WM, Chow CC, Kadir KA, Suwanwalaikorn S, Vaz JA, Bech OM; BIAsp-3021 study group. Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes. Diabetes Obes Metab. 2007 Sep;9(5):724-32. doi: 10.1111/j.1463-1326.2007.00743.x. Epub 2007 Jun 26.
- 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 7 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 7 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 5 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 11 Jan 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 Australia, Malaysia, Hong Kong, Philippines, Taiwan and 2 more countries. 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?
HbA1c (time frame: after 11 weeks of treatment). 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 NCT00605111, 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 11 Jan 2017.