DiabetesPhase 4EUROMIXNCT00619697
Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
A Phase 4 study testing biphasic insulin aspart, insulin glargine and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 54 sites in 7 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy 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 glargine and metformin
- How many people
- 260 participants
- Where
- 54 sitesin 7 countries
- Study dates
- Dec 2003to Mar 2005
- 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 6 months
- Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
- Previous treatment with oral antidiabetic drugs for at least 4 months
- Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
- BMI below 40 kg/m2
- HbA1c between 7-12%
- Able and willing to perform self-plasma glucose monitoring
Who cannot join
- The receipt of any other investigational drug within 4 weeks before screening
- A history of drug or alcohol abuse within the last 12 months
- Severe, uncontrolled hypertension
- Known or suspected allergy to trial products or related products
Trial locations and contacts
54 sites in 7 countries.
54 sites in 7 countries
Germany31 sites
Novo Nordisk Investigational Site
Augsburg, 86150
Novo Nordisk Investigational Site
Castrop-Rauxel, 44577
Novo Nordisk Investigational Site
Deggingen, 73326
Novo Nordisk Investigational Site
Duisburg, 47053
Novo Nordisk Investigational Site
Erlangen, 91054
Novo Nordisk Investigational Site
Eschweiler, 52249
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Fulda, 36037
Novo Nordisk Investigational Site
Hamburg, 22119
Novo Nordisk Investigational Site
Hamburg, 22177
Novo Nordisk Investigational Site
Herne, 44623
Novo Nordisk Investigational Site
Kippenheim, 77971
Novo Nordisk Investigational Site
Lauffen am Neckar, 74348
Novo Nordisk Investigational Site
Leverkusen, 51377
Novo Nordisk Investigational Site
Ludwigsburg, 71634
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Ludwigshafen, 67063
Novo Nordisk Investigational Site
Mannheim, 68161
Novo Nordisk Investigational Site
Mannheim, 68199
Novo Nordisk Investigational Site
Marburg, 35037
Novo Nordisk Investigational Site
Marburg, 35043
Novo Nordisk Investigational Site
Mülheim, 45468
Novo Nordisk Investigational Site
Neunkirchen, 66539
Novo Nordisk Investigational Site
Ostercappeln, 49179
Novo Nordisk Investigational Site
Pritzwalk, 16928
Novo Nordisk Investigational Site
Rosenheim, 83022
Novo Nordisk Investigational Site
Viernheim, 68519
Novo Nordisk Investigational Site
Weil der Stadt, 71263
Novo Nordisk Investigational Site
Weiskirchen, 66709
Novo Nordisk Investigational Site
Witten, 58452
Novo Nordisk Investigational Site
Witten, 58456
Austria8 sites
Novo Nordisk Investigational Site
Ebreichsdorf, 2483
Novo Nordisk Investigational Site
Feldkirch, 6807
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Horn, A 3580
Novo Nordisk Investigational Site
Oberpullendorf, 7350
Novo Nordisk Investigational Site
Salzburg, 5010
Novo Nordisk Investigational Site
Villach, A 9500
Novo Nordisk Investigational Site
Waidhofen A.d. Thaya, A 3830
Poland5 sites
Novo Nordisk Investigational Site
Częstochowa, 42-200
Novo Nordisk Investigational Site
Gdynia, 81-366
Novo Nordisk Investigational Site
Lublin, 20 011
Novo Nordisk Investigational Site
Otwock, 05-400
Novo Nordisk Investigational Site
Poznan, 61-696
Hungary3 sites
Novo Nordisk Investigational Site
Budapest, 1041
Novo Nordisk Investigational Site
Eger, 3300
Novo Nordisk Investigational Site
Szekszárd, 7100
Slovenia3 sites
Novo Nordisk Investigational Site
Celje, 3000
Novo Nordisk Investigational Site
Ljubljana, 1000
Novo Nordisk Investigational Site
Maribor, 2000
Czechia2 sites
Novo Nordisk Investigational Site
Brno, 65691
Novo Nordisk Investigational Site
Liberec, 46001
Slovakia2 sites
Novo Nordisk Investigational Site
L'ubochna, 03491
Novo Nordisk Investigational Site
Martin, 036 59
About this study
Official title: Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart, insulin glargine, metformin, glimepiride
- 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
Also called BIASP, NovoMix 30, NovoLog 70/30 Mix
insulin glargineDrug
metforminDrug
glimepirideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 26 weeks of treatment
Secondary outcomes (5)
HbA1c
Measured: after 16 weeks of treatment
Plasma glucose profiles
Change in body mass index
Incidence of hypoglycaemic episodes
Safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startDec 2003
- Primary completionMar 2005
- Study completionMar 2005
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
- 260 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
- NCT00619697
- Sponsor's protocol ID
- BIASP-1564
- Acronym
- EUROMIX
- Status last verified
- Jan 2017
- First submitted
- 11 Feb 2008
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kann PH, Wascher T, Zackova V, Moeller J, Medding J, Szocs A, Mokan M, Mrevlje F, Regulski M. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):527-32. doi: 10.1055/s-2006-949655.
PubMed 17115351
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 Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00619697
- Acronym / sponsor ID
- EUROMIX / BIASP-1564
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 21 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 Europe. The aim of this trial is to investigate the efficacy 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 (7 listed)
- Type 2 diabetes for at least 6 months
- Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
- Previous treatment with oral antidiabetic drugs for at least 4 months
- Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
- BMI below 40 kg/m2
Key exclusion criteria (4 listed)
- The receipt of any other investigational drug within 4 weeks before screening
- A history of drug or alcohol abuse within the last 12 months
- Severe, uncontrolled hypertension
- Known or suspected allergy to trial products or related products
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, NovoMix 30, NovoLog 70/30 Mix | Drug | – |
| insulin glargine | Drug | – |
| metformin | Drug | – |
| glimepiride | Drug | – |
Primary outcome
HbA1c
Time frame: after 26 weeks of treatment
5 secondary outcomes
HbA1c
Time frame: after 16 weeks of treatment
Plasma glucose profiles
Change in body mass index
Incidence of hypoglycaemic episodes
Safety profile
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 17115351Kann PH, Wascher T, Zackova V, Moeller J, Medding J, Szocs A, Mokan M, Mrevlje F, Regulski M. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):527-32. doi: 10.1055/s-2006-949655.
- 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
PAW-Hydrogel for Chronic Wound Healing
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
54 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, insulin glargine and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 54 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 7 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 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 54 sites in Germany, Austria, Poland, Hungary, Slovenia 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 26 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 NCT00619697, 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.