DiabetesNCT00709683
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Tunisia.
Trial summary
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions. 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 30
- How many people
- 216 participants
- Where
- 1 siteTunisia
- Study dates
- May 2008to May 2009
- 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 diabetic patients
Who may be able to join
- Type 2 diabetes having failed on basal insulin with or without OAD
- HbA1c greater than 7.0%
Who cannot join
- Subjects being unlikely to comply with protocol requirements
- Subjects who previously enrolled in this study
- Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
- Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.
- 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
Also called NovoMix® 30
Start 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
Measured: during 26 weeks of treatment
Secondary outcomes (9)
Number of serious adverse drug reactions
Measured: during 26 weeks of treatment
Number of serious adverse events
Measured: during 26 weeks of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Measured: during 26 weeks of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Measured: during 26 weeks of treatment
Weight (BMI) change from baseline
Measured: At the end of the study
HbA1c change from baseline
Measured: At the end of the study
Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%
Measured: At the end of the study
Average (mean) fasting plasma glucose level
Measured: At the end of the study
Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
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
- 216 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
- NCT00709683
- Sponsor's protocol ID
- BIASP-3572
- Status last verified
- Mar 2016
- First submitted
- 1 Jul 2008
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy
- ClinicalTrials.gov ID
- NCT00709683
- Acronym / sponsor ID
- BIASP-3572
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Jul 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 Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: biphasic insulin aspart 30 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetic patients
Key inclusion criteria (2 listed)
- Type 2 diabetes having failed on basal insulin with or without OAD
- HbA1c greater than 7.0%
Key exclusion criteria (4 listed)
- Subjects being unlikely to comply with protocol requirements
- Subjects who previously enrolled in this study
- Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
- Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
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® 30Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
Primary outcome
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
Time frame: during 26 weeks of treatment
9 secondary outcomes
Number of serious adverse drug reactions
Time frame: during 26 weeks of treatment
Number of serious adverse events
Time frame: during 26 weeks of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Time frame: during 26 weeks of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time frame: during 26 weeks of treatment
Weight (BMI) change from baseline
Time frame: At the end of the study
HbA1c change from baseline
Time frame: At the end of the study
Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%
Time frame: At the end of the study
Average (mean) fasting plasma glucose level
Time frame: At the end of the study
Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level
Time frame: At the end of the study
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 7 Mar 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 Tunisia.
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 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 7 Mar 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 Tunisia. 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 major hypoglycaemic events reported as serious adverse drug reactions (time frame: during 26 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 7 Mar 2016.