DiabetesNCT00755833
Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Slovenia.
Trial summary
This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 50
- How many people
- 270 participants
- Where
- 1 siteSlovenia
- Study dates
- Sep 2008to Apr 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- Type 2 diabetes treated with biphasic human insulin with or without metformin
- Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50
Who cannot join
- Subjects with diagnosed type 1 diabetes mellitus
- Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
- Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
- Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
- Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia
This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 50
- 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 50Drug
Also called NovoMix® 50
Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: biphasic insulin aspart 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: At 0, 3, 6, 9, 12 months
Secondary outcomes (7)
Percentage of subjects achieving target HbA1c
Measured: At 0, 3, 6, 9, 12 months
Change in FPG (fasting plasma glucose)
Measured: At 0, 3, 6, 9, 12 months
Change in PPG (postprandial glucose)
Measured: At 0, 3, 6, 9, 12 months
Change in number of hypoglycaemic events
Measured: At 0, 3, 6, 9, 12 months
Change in insulin presentation
Measured: At 0, 3, 6, 9, 12 months
Dose and number of injections
Measured: At 0, 3, 6, 9, 12 months
Number of ADRs (adverse drug reaction)
Measured: At 0, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionApr 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 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
- NCT00755833
- Sponsor's protocol ID
- BIASP-3674
- Status last verified
- Oct 2016
- First submitted
- 18 Sep 2008
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia
- ClinicalTrials.gov ID
- NCT00755833
- Acronym / sponsor ID
- BIASP-3674
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Sep 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 study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: biphasic insulin aspart 50 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (2 listed)
- Type 2 diabetes treated with biphasic human insulin with or without metformin
- Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50
Key exclusion criteria (5 listed)
- Subjects with diagnosed type 1 diabetes mellitus
- Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
- Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
- Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
- Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months
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 50Also: NovoMix® 50Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice. | Drug | A |
Primary outcome
Change in HbA1c
Time frame: At 0, 3, 6, 9, 12 months
7 secondary outcomes
Percentage of subjects achieving target HbA1c
Time frame: At 0, 3, 6, 9, 12 months
Change in FPG (fasting plasma glucose)
Time frame: At 0, 3, 6, 9, 12 months
Change in PPG (postprandial glucose)
Time frame: At 0, 3, 6, 9, 12 months
Change in number of hypoglycaemic events
Time frame: At 0, 3, 6, 9, 12 months
Change in insulin presentation
Time frame: At 0, 3, 6, 9, 12 months
Dose and number of injections
Time frame: At 0, 3, 6, 9, 12 months
Number of ADRs (adverse drug reaction)
Time frame: At 0, 3, 6, 9, 12 months
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 31 Oct 2016.
- 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 Slovenia.
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 2 inclusion and 5 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 31 Oct 2016. 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 Slovenia. 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?
Change in HbA1c (time frame: At 0, 3, 6, 9, 12 months). 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 31 Oct 2016.