DiabetesPhase 3NCT00617565
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes
A Phase 3 study testing biphasic insulin aspart and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 6 sites in China.
Trial summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart and biphasic human insulin
- How many people
- 219 participants
- Where
- 6 sitesChina
- Study dates
- 8 Jul 2003to 26 Nov 2003
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or 2 diabetes for at least 3 months
- Stabilised on current treatment with premixed human insulin for at least 4 weeks
- Body mass index (BMI) between 18-40 kg/m2
- HbA1c below 13.0%
- Able and willing to perform self-blood glucose monitoring
Who cannot join
- The receipt of any investigational drug within the last three months prior to this trial
- Has a history of drug abuse or alcohol dependence within the last 5 years
- Active proliferative retinopathy requiring laser or surgical intervention within the last year
- Recurrent major hypoglycaemia as judged by the Investigator
- Known or suspected allergy to trial product or related product
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100034
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100853
Novo Nordisk Investigational Site
Beijing, 100029
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200032
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.
- Being tested
- biphasic insulin aspart, biphasic human insulin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, 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
Also called BIASP
biphasic human insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hr postprandial plasma glucose (PPPG) excursion
Measured: after 12 weeks of treatment
Secondary outcomes (2)
HbA1c
Fasting plasma glucose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study start8 Jul 2003
- Primary completion26 Nov 2003
- Study completion26 Nov 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 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
- NCT00617565
- Sponsor's protocol ID
- BIASP-1536
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2008
- 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-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics
- ClinicalTrials.gov ID
- NCT00617565
- Acronym / sponsor ID
- BIASP-1536
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2003 (actual)
- Primary completion
- 26 Nov 2003 (actual)
- Study completion
- 26 Nov 2003 (actual)
- First posted
- 18 Feb 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 of biphasic insulin aspart 30 on postprandial glycaemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 or 2 diabetes for at least 3 months
- Stabilised on current treatment with premixed human insulin for at least 4 weeks
- Body mass index (BMI) between 18-40 kg/m2
- HbA1c below 13.0%
- Able and willing to perform self-blood glucose monitoring
Key exclusion criteria (5 listed)
- The receipt of any investigational drug within the last three months prior to this trial
- Has a history of drug abuse or alcohol dependence within the last 5 years
- Active proliferative retinopathy requiring laser or surgical intervention within the last year
- Recurrent major hypoglycaemia as judged by the Investigator
- Known or suspected allergy to trial product or related product
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 aspartAlso: BIASP | Drug | – |
| biphasic human insulin | Drug | – |
Primary outcome
2-hr postprandial plasma glucose (PPPG) excursion
Time frame: after 12 weeks of treatment
2 secondary outcomes
HbA1c
Fasting plasma glucose
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biphasic insulin aspart and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 6 sites in China.
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: 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 6 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
2-hr postprandial plasma glucose (PPPG) excursion (time frame: after 12 weeks of treatment). 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.