DiabetesPhase 3NCT00600626
Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes
A Phase 3 study testing biphasic insulin aspart, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 55 sites in 13 countries.
Trial summary
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in 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, insulin NPH and insulin aspart
- How many people
- 394 participants
- Where
- 55 sitesin 13 countries
- Study dates
- Jan 2004to Jul 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
- HbA1c between 8.0-10.5%
- Body mass index (BMI) below 35.0 kg/m2
- Able and willing to perform self-monitoring of blood glucose
Who cannot join
- Total daily insulin dose of 1.80 IU/kg or more
- Known or suspected allergy to trial product or related products
- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
Trial locations and contacts
55 sites in 13 countries.
55 sites in 13 countries
Germany8 sites
Novo Nordisk Investigational Site
Bad Heilbrunn, 83670
Novo Nordisk Investigational Site
Neuss, 41460
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Schaafheim, 64850
Novo Nordisk Investigational Site
Schwedt, 16303
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Wiesbaden, 65183
Novo Nordisk Investigational Site
Würzburg, 97072
United Kingdom8 sites
Novo Nordisk Investigational Site
Bradford, BD9 6RJ
Novo Nordisk Investigational Site
Brighton, BN2 5BE
Novo Nordisk Investigational Site
Coventry, CV6 2FL
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Glasgow, G42 9TY
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
York, YO3 7HE
Spain7 sites
Novo Nordisk Investigational Site
Córdoba, 14004
Novo Nordisk Investigational Site
Madrid, 28040
Novo Nordisk Investigational Site
Orihuela, 03300
Novo Nordisk Investigational Site
Sabadell, 08208
Novo Nordisk Investigational Site
Seville, 41009
Novo Nordisk Investigational Site
Seville, 41013
Novo Nordisk Investigational Site
Valladolid, 47011
Sweden6 sites
Novo Nordisk Investigational Site
Falun, 791 82
Novo Nordisk Investigational Site
Gothenburg, 416 85
Novo Nordisk Investigational Site
Linköping, 581 85
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Mölndal, 431 80
Novo Nordisk Investigational Site
Uppsala, 751 85
Poland5 sites
Novo Nordisk Investigational Site
Lodz, 90-030
Novo Nordisk Investigational Site
Lublin, 20-718
Novo Nordisk Investigational Site
Szczecin, 71-455
Novo Nordisk Investigational Site
Warsaw, 03-242
Novo Nordisk Investigational Site
Zabrze, 41-800
France4 sites
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Vénissieux, 69200
Netherlands4 sites
Novo Nordisk Investigational Site
Beverwijk, 1942 LE
Novo Nordisk Investigational Site
Delft, 2625 AD
Novo Nordisk Investigational Site
Eindhoven, 5631 BM
Novo Nordisk Investigational Site
Rotterdam, 3011 TD
Romania4 sites
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, 400006
Novo Nordisk Investigational Site
Constanța, 900591
Novo Nordisk Investigational Site
Iași, 700111
Novo Nordisk Investigational Site
Timișoara, 300736
Russia4 sites
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Saint Petersburg, 194291
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Malaysia2 sites
Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
About this study
Official title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart, insulin NPH, 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
insulin NPHDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 4 months of treatment
Secondary outcomes (4)
8-point blood glucose profile
incidence of hypoglycaemic episodes
safety profiles
changes in body weight and vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionJul 2004
- Study completionJul 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 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
- NCT00600626
- Sponsor's protocol ID
- BIASP-1486
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2008
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.
PubMed 17115349
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00600626
- Acronym / sponsor ID
- BIASP-1486
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 25 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 Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.
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
- Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
- HbA1c between 8.0-10.5%
- Body mass index (BMI) below 35.0 kg/m2
- Able and willing to perform self-monitoring of blood glucose
Key exclusion criteria (3 listed)
- Total daily insulin dose of 1.80 IU/kg or more
- Known or suspected allergy to trial product or related products
- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
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 | – |
| insulin NPH | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after 4 months of treatment
4 secondary outcomes
8-point blood glucose profile
incidence of hypoglycaemic episodes
safety profiles
changes in body weight and vital signs
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 6 Jan 2017.
- Results publication: PubMed 17115349Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.
- 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
55 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biphasic insulin aspart, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 55 sites in 13 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 3 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 6 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 55 sites in Germany, United Kingdom, Spain, Sweden, Poland and 8 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 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?
HbA1c (time frame: after 4 months 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 NCT00600626, 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 6 Jan 2017.