DiabetesPhase 4NCT01467401
Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes
A Phase 4 study testing biphasic insulin aspart and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 57 sites in 3 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with 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 and biphasic human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 57 sitesin 3 countries
- Study dates
- 19 Aug 2002to 15 May 2003
- 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
- Insulin treatment for the pase 3 months
- HbA1c (glycosylated haemoglobin) below 13%
- BMI (Body Mass Index) below 40 kg/m^2
- Ability and willingness to perform self-blood glucose monitoring
Who cannot join
- Receipt of any investigational drug within 4 weeks prior to this trial
- Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
- Total daily insulin dosage less than or equal to 1.8 IU/kg
Trial locations and contacts
57 sites in 3 countries.
57 sites in 3 countries
Sweden39 sites
Novo Nordisk Investigational Site
Arvika, 671 80
Novo Nordisk Investigational Site
Avesta, 774 82
Novo Nordisk Investigational Site
Bjuv, 267 38
Novo Nordisk Investigational Site
Broby, 280 60
Novo Nordisk Investigational Site
Färgelanda, 458 32
Novo Nordisk Investigational Site
Gothenburg, 416 65
Novo Nordisk Investigational Site
Gothenburg, 416 85
Novo Nordisk Investigational Site
Gothenburg, 417 02
Novo Nordisk Investigational Site
Gothenburg, 417 17
Novo Nordisk Investigational Site
Grästorp, 467 22
Novo Nordisk Investigational Site
Habo, 566 32
Novo Nordisk Investigational Site
Härnösand, 871 82
Novo Nordisk Investigational Site
Hässleholm, 281 25
Novo Nordisk Investigational Site
Helsingborg, 254 57
Novo Nordisk Investigational Site
Jönköping, 551 11
Novo Nordisk Investigational Site
Karlstad, 651 85
Novo Nordisk Investigational Site
Karlstad, 652 24
Novo Nordisk Investigational Site
Kristianstad, 291 38
Novo Nordisk Investigational Site
Kristinehamn, 681 80
Novo Nordisk Investigational Site
Kungsbacka, 434 80
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Mellerud, 464 30
Novo Nordisk Investigational Site
Mölndal, 431 80
Novo Nordisk Investigational Site
Norrköping, 602 36
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Örebro, 702 15
Novo Nordisk Investigational Site
Örebro, 703 51
Novo Nordisk Investigational Site
Östersund, 831 62
Novo Nordisk Investigational Site
Östersund, 831 83
Novo Nordisk Investigational Site
Säffle, 661 81
Novo Nordisk Investigational Site
Skövde, 541 85
Novo Nordisk Investigational Site
Stockholm, 116 91
Novo Nordisk Investigational Site
Tomelilla, 273 34
Novo Nordisk Investigational Site
Torsby, 685 29
Novo Nordisk Investigational Site
Trollhättan, 461 40
Novo Nordisk Investigational Site
Trollhättan, 461 85
Novo Nordisk Investigational Site
Tyresö, 135 21
Novo Nordisk Investigational Site
Uddevalla, 451 80
Novo Nordisk Investigational Site
Värnamo, 331 85
Denmark9 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Esbjerg, 6700
Novo Nordisk Investigational Site
Herning, 7400
Novo Nordisk Investigational Site
Holbæk, 4300
Novo Nordisk Investigational Site
Næstved, 4700
Novo Nordisk Investigational Site
Randers
Novo Nordisk Investigational Site
Silkeborg, 8600
Novo Nordisk Investigational Site
Skive, 7800
Novo Nordisk Investigational Site
Viborg
Norway9 sites
Novo Nordisk Investigational Site
Åsgårdstrand
Novo Nordisk Investigational Site
Bekkestua, 1357
Novo Nordisk Investigational Site
Bergen, NO-5012
Novo Nordisk Investigational Site
Haugesund
Novo Nordisk Investigational Site
Hønefoss
Novo Nordisk Investigational Site
Moelv
Novo Nordisk Investigational Site
Oslo, 0370
Novo Nordisk Investigational Site
Tromsø, 9038
Novo Nordisk Investigational Site
Vennesla
About this study
Official title: A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart, biphasic human insulin
- 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
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
biphasic human insulinDrug
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: biphasic insulin aspart |
| B | Active comparator | Not described Receives: Drug: biphasic human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycolated haemoglobin)
Secondary outcomes (5)
Prandial increment in blood glucose
7-point blood glucose profile
Number and severity of adverse events
Number and severity of local tolerability issues at the injection site
Number and severity of hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study start19 Aug 2002
- Primary completion15 May 2003
- Study completion15 May 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 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
- NCT01467401
- Sponsor's protocol ID
- BIASP-1394
- Status last verified
- Feb 2017
- First submitted
- 4 Nov 2011
- 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-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01467401
- Acronym / sponsor ID
- BIASP-1394
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2002 (actual)
- Primary completion
- 15 May 2003 (actual)
- Study completion
- 15 May 2003 (actual)
- First posted
- 8 Nov 2011 (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 and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: biphasic insulin aspart |
| B | Active comparator | Drug: biphasic human insulin |
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
- Insulin treatment for the pase 3 months
- HbA1c (glycosylated haemoglobin) below 13%
- BMI (Body Mass Index) below 40 kg/m^2
- Ability and willingness to perform self-blood glucose monitoring
Key exclusion criteria (3 listed)
- Receipt of any investigational drug within 4 weeks prior to this trial
- Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
- Total daily insulin dosage less than or equal to 1.8 IU/kg
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 aspartIndividually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily | Drug | A |
| biphasic human insulinIndividually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily | Drug | B |
Primary outcome
HbA1c (glycolated haemoglobin)
5 secondary outcomes
Prandial increment in blood glucose
7-point blood glucose profile
Number and severity of adverse events
Number and severity of local tolerability issues at the injection site
Number and severity of hypoglycaemic episodes
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
57 sites in 3 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 and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 57 sites in 3 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 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 57 sites in Sweden, Denmark, Norway. 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 (glycolated haemoglobin). 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.