DiabetesPhase 3NCT00184574

Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

A Phase 3 study testing biphasic insulin aspart and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 108 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug. 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 and metformin
How many people: 603 participants
Where: 108 sitesin 18 countries
Study dates: Apr 2005to Mar 2006
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 insulin
Currently treated with Metformin
HbA1c: 7.5-12.0%

Who cannot join

Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
Metformin contraindications according to local practice
TZDs within 6 months prior to randomisation

Trial locations and contacts

108 sites in 18 countries.

Country

City, postcode or hospital

108 sites in 18 countries

Germany15 sites

Novo Nordisk Investigational Site
Bad Heilbrunn, 83670
Novo Nordisk Investigational Site
Beckum, 59269
Novo Nordisk Investigational Site
Berlin, 10318
Novo Nordisk Investigational Site
Dormagen, 41539
Novo Nordisk Investigational Site
Dresden, 01219
Novo Nordisk Investigational Site
Duisburg, 47259
Novo Nordisk Investigational Site
Genthin, 39307
Novo Nordisk Investigational Site
Kippenheim, 77971
Novo Nordisk Investigational Site
München, 81479
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Saarbrücken, 66121
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Schönebeck, 39218
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Würzburg, 97072

Other trials in Germany

Italy12 sites

Novo Nordisk Investigational Site
Catania, 95126
Novo Nordisk Investigational Site
Florence, 50141
Novo Nordisk Investigational Site
Gazi, 98124
Novo Nordisk Investigational Site
Lucca, 55100
Novo Nordisk Investigational Site
Milan, 20157
Novo Nordisk Investigational Site
Padova, 35143
Novo Nordisk Investigational Site
Roma, 00133
Novo Nordisk Investigational Site
Roma, 00195
Novo Nordisk Investigational Site
Salerno, 84125
Novo Nordisk Investigational Site
Savigliano (CN), 12038
Novo Nordisk Investigational Site
Terni, 05100
Novo Nordisk Investigational Site
Udine, 33100

Other trials in Italy

France11 sites

Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Boulogne-Billancourt, 92100
Novo Nordisk Investigational Site
Brest, 29609
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Chesnay, 78150
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Metz, 57000
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Perpignan, 66046

Other trials in France

Spain10 sites

Novo Nordisk Investigational Site
Albacete, 02006
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
L'Hospitalet de Llobregat, 08907
Novo Nordisk Investigational Site
Madrid, 28040
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Mostoles - Madrid -, 28935
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
San Juan, 03550
Novo Nordisk Investigational Site
Valencia, 46014
Novo Nordisk Investigational Site
Zaragoza, 50009

Other trials in Spain

United Kingdom9 sites

Novo Nordisk Investigational Site
Bradford, BD9 6RJ
Novo Nordisk Investigational Site
Brighton, BN2 5BE
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Cosham, PO6 3LY
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Salford, M6 8HD
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Watford, WD18 0HB

Other trials in United Kingdom

Netherlands6 sites

Novo Nordisk Investigational Site
's-Hertogenbosch, 5223 GV
Novo Nordisk Investigational Site
Amersfoort, 3816 CP
Novo Nordisk Investigational Site
Brunssum, 6442 BE
Novo Nordisk Investigational Site
Hoogeveen, 7909 AA
Novo Nordisk Investigational Site
Roosendaal, 4708 AE
Novo Nordisk Investigational Site
Rotterdam, 3011 TD

Other trials in Netherlands

Poland6 sites

Novo Nordisk Investigational Site
Lublin, 20-538
Novo Nordisk Investigational Site
Mazowieckie, 09-400
Novo Nordisk Investigational Site
Poznan, 61-696
Novo Nordisk Investigational Site
Szczecin, 71-455
Novo Nordisk Investigational Site
Warsaw, 01-911
Novo Nordisk Investigational Site
Zabrze, 41-800

Other trials in Poland

Austria5 sites

Novo Nordisk Investigational Site
Bregenz, A - 6900
Novo Nordisk Investigational Site
Feldkirch, 6807
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Salzburg, 5010
Novo Nordisk Investigational Site
Vienna, A-1130

Other trials in Austria

Belgium5 sites

Novo Nordisk Investigational Site
Bonheiden, 2820
Novo Nordisk Investigational Site
Brussels, 1070
Novo Nordisk Investigational Site
Genk, 3600
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Russia5 sites

Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 123448
Novo Nordisk Investigational Site
Moscow, 127644
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 198013

Other trials in Russia

Switzerland5 sites

Novo Nordisk Investigational Site
Biel, 2502
Novo Nordisk Investigational Site
Interlaken-Unterseen, 3800
Novo Nordisk Investigational Site
Sankt Gallen, 9000
Novo Nordisk Investigational Site
Winterthur, 8400
Novo Nordisk Investigational Site
Zurich, 8002

Other trials in Switzerland

Romania4 sites

Novo Nordisk Investigational Site
Galati, 800578
Novo Nordisk Investigational Site
Ploieşti, Prahova, 100097
Novo Nordisk Investigational Site
Suceava, 720062
Novo Nordisk Investigational Site
Târgu Mureş, 540061

Other trials in Romania

Czechia3 sites

Novo Nordisk Investigational Site
Brno, 65691
Novo Nordisk Investigational Site
Hradec Králové, 500 36
Novo Nordisk Investigational Site
Prague, 15018

Other trials in Czechia

Denmark3 sites

Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Odense, 5000

Other trials in Denmark

Hungary3 sites

Novo Nordisk Investigational Site
Budapest, 1125
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Veszprém, 8200

Other trials in Hungary

Turkey (Türkiye)3 sites

Novo Nordisk Investigational Site
Ankara, 06630
Novo Nordisk Investigational Site
Bursa, 16059
Novo Nordisk Investigational Site
Istanbul, 34098

Other trials in Turkey (Türkiye)

Bulgaria2 sites

Novo Nordisk Investigational Site
Pleven, 5800
Novo Nordisk Investigational Site
Sofia, 1431

Other trials in Bulgaria

Slovenia1 site

Novo Nordisk Investigational Site
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart, metformin
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
metforminDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c
Measured: after 36 weeks

Secondary outcomes (3)

8-point plasma glucose profiles
Safety variables
Other glycemic variables

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Mar 2006

First posted16 Sep 2005 (estimated)
Study startApr 2005
Primary completionMar 2006
Study completionMar 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Single group
Masking: None (open label)
Enrolment: 603 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00184574
Sponsor's protocol ID: BIASP-1440
Status last verified: Jan 2017
First submitted: 12 Sep 2005
Last updated: 5 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. doi: 10.1111/j.1463-1326.2006.00654.x.
PubMed 17697056
Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, Lopez de la Torre M, Liebl A. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):700-8. doi: 10.1111/j.1463-1326.2009.01035.x. Epub 2009 May 19.
PubMed 19476479

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).
ClinicalTrials.gov ID: NCT00184574
Acronym / sponsor ID: BIASP-1440
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 603 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Mar 2006 (actual)
Study completion: Mar 2006 (actual)
First posted: 16 Sep 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
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 (4 listed)

Type 2 diabetes
Currently treated with insulin
Currently treated with Metformin
HbA1c: 7.5-12.0%

Key exclusion criteria (3 listed)

Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
Metformin contraindications according to local practice
TZDs within 6 months prior to randomisation

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	–
metformin	Drug	–

Primary outcome

HbA1c
Time frame: after 36 weeks

3 secondary outcomes

8-point plasma glucose profiles
Safety variables
Other glycemic variables

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 5 Jan 2017.
Results publication: PubMed 17697056Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. doi: 10.1111/j.1463-1326.2006.00654.x.
Results publication: PubMed 19476479Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, Lopez de la Torre M, Liebl A. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):700-8. doi: 10.1111/j.1463-1326.2009.01035.x. Epub 2009 May 19.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
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Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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

108 sites in 18 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 and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 108 sites in 18 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 4 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 5 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 108 sites in Germany, Italy, France, Spain, United Kingdom and 13 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 36 weeks). 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 NCT00184574, which also lists 2 linked publications.

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 5 Jan 2017.