DiabetesStartNCT01486875
Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Sweden.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 30
- Type of treatment
- Injection or infusion
- How many people
- 1,155 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to Jan 2008
- Phase
- Observational
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate
Who may be able to join
- Subjects with type 2 diabetes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment
This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30
- 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 aspart 30Drug
Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 | Not described Receives: Drug: biphasic insulin aspart 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse drug reactions (SADRs)
Measured: Week 26
Incidence of major hypoglycaemic events
Measured: Week 26
Secondary outcomes (3)
Number of all hypoglycaemic events
Measured: In the 4 weeks prior to week 12 and week 26, respectively
HbA1c (glycosylated haemoglobin A1c)
Measured: Week 26
Fasting Plasma Glucose (FPG)
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJan 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,155 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
- NCT01486875
- Sponsor's protocol ID
- BIASP-1721
- Acronym
- Start
- Status last verified
- Jan 2017
- First submitted
- 5 Dec 2011
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M; Swedish BIAsp Study Group. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011 Jul;5(2):89-94. doi: 10.1016/j.pcd.2011.02.003. Epub 2011 Mar 26.
PubMed 21440523
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
- NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment
- ClinicalTrials.gov ID
- NCT01486875
- Acronym / sponsor ID
- Start / BIASP-1721
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,155 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Dec 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 evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 | – | Drug: biphasic insulin aspart 30 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate
Key inclusion criteria (1 listed)
- Subjects with type 2 diabetes
Key exclusion criteria (0 listed)
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 30Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily | Drug | BIAsp 30 |
Primary outcome
Incidence of serious adverse drug reactions (SADRs)
Time frame: Week 26
Incidence of major hypoglycaemic events
Time frame: Week 26
3 secondary outcomes
Number of all hypoglycaemic events
Time frame: In the 4 weeks prior to week 12 and week 26, respectively
HbA1c (glycosylated haemoglobin A1c)
Time frame: Week 26
Fasting Plasma Glucose (FPG)
Time frame: Week 26
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 21440523Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M; Swedish BIAsp Study Group. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011 Jul;5(2):89-94. doi: 10.1016/j.pcd.2011.02.003. Epub 2011 Mar 26.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Sweden.
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 1 inclusion and 0 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 1 site in Sweden. 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.
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?
Incidence of serious adverse drug reactions (SADRs) (time frame: Week 26). The study lists 2 primary outcomes in all. 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 NCT01486875, 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.