DiabetesNCT00834262
Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Israel.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients. 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 30, biphasic insulin aspart 50 and biphasic insulin aspart 70
- How many people
- 339 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30, NovoMix® 50 or NovoMix® 70 or combinations, will be eligible A nonrandomized sample of approximately 325 subjects with Type 2 diabetes mellitus will be enrolled.
Who may be able to join
- Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible
Who cannot join
- Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients
This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70
- 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
Also called NovoMix® 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
biphasic insulin aspart 50Drug
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
biphasic insulin aspart 70Drug
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all hypoglycaemic episodes
Measured: during 13 weeks of treatment
Secondary outcomes (11)
Number of adverse drug reactions
Measured: during 13 weeks of treatment
Number of adverse events
Measured: during 13 weeks of treatment
Number of all major hypoglycaemic (daytime and nocturnal) episodes
Measured: during 13 weeks of treatment
Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes
Measured: during 13 weeks of treatment
Number of major hypoglycaemic episodes related to omission of a meal after injection
Measured: during 13 weeks of treatment
Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration
Measured: during 13 weeks of treatment
Weight (BMI) change
Measured: at the end of the study after 13 weeks of treatment
HbA1c change
Measured: at the end of the study after 13 weeks of treatment
Percentage of patients reaching the target of HbA1c of 7.0% or less
Measured: at the end of the study after 13 weeks of treatment
Variability in fasting blood glucose values and average (mean) fasting blood glucose level
Measured: at the end of the study after 13 weeks of treatment
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level
Measured: at the end of the study after 13 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionFeb 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 339 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
- NCT00834262
- Sponsor's protocol ID
- BIASP-3669
- Status last verified
- Oct 2016
- First submitted
- 2 Feb 2009
- 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 Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00834262
- Acronym / sponsor ID
- BIASP-3669
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Feb 2009 (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 Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 50, Drug: biphasic insulin aspart 70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30, NovoMix® 50 or NovoMix® 70 or combinations, will be eligible A nonrandomized sample of approximately 325 subjects with Type 2 diabetes mellitus will be enrolled.
Key inclusion criteria (1 listed)
- Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible
Key exclusion criteria (2 listed)
- Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within the 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 30Also: NovoMix® 30Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| biphasic insulin aspart 50Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| biphasic insulin aspart 70Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
Primary outcome
Number of all hypoglycaemic episodes
Time frame: during 13 weeks of treatment
11 secondary outcomes
Number of adverse drug reactions
Time frame: during 13 weeks of treatment
Number of adverse events
Time frame: during 13 weeks of treatment
Number of all major hypoglycaemic (daytime and nocturnal) episodes
Time frame: during 13 weeks of treatment
Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes
Time frame: during 13 weeks of treatment
Number of major hypoglycaemic episodes related to omission of a meal after injection
Time frame: during 13 weeks of treatment
Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration
Time frame: during 13 weeks of treatment
Weight (BMI) change
Time frame: at the end of the study after 13 weeks of treatment
HbA1c change
Time frame: at the end of the study after 13 weeks of treatment
Percentage of patients reaching the target of HbA1c of 7.0% or less
Time frame: at the end of the study after 13 weeks of treatment
Variability in fasting blood glucose values and average (mean) fasting blood glucose level
Time frame: at the end of the study after 13 weeks of treatment
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level
Time frame: at the end of the study after 13 weeks of treatment
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 Israel.
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 2 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 Israel. 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?
Number of all hypoglycaemic episodes (time frame: during 13 weeks of treatment). 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.