DiabetesIMPROVE LifeNCT00696163
Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in India.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India. 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
- 24,975 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2008to Mar 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 diabetes
Who may be able to join
- Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.
Who cannot join
- Currently treated with NovoMix® 30
- Subjects who are unlikely to comply with protocol requirements
- Previously enrolled in this study
- Hypersensitivity to biphasic insulin aspart or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.
- 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, BIAsp30
Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion
| 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.
Change in Quality of Life from baseline (using QoLD questionnaire)
Measured: From baseline to 26 weeks of treatment
Secondary outcomes (2)
Safety
Measured: After 26 weeks
Efficacy
Measured: After 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24,975 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
- NCT00696163
- Sponsor's protocol ID
- BIASP-3555
- Acronym
- IMPROVE Life
- Status last verified
- Oct 2016
- First submitted
- 10 Jun 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 Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00696163
- Acronym / sponsor ID
- IMPROVE Life / BIASP-3555
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,975 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Jun 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 Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.
Study design
- Observational model
- Case only
- 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 diabetes
Key inclusion criteria (1 listed)
- Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.
Key exclusion criteria (5 listed)
- Currently treated with NovoMix® 30
- Subjects who are unlikely to comply with protocol requirements
- Previously enrolled in this study
- Hypersensitivity to biphasic insulin aspart or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming 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 30Also: NovoMix® 30, BIAsp30Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion | Drug | A |
Primary outcome
Change in Quality of Life from baseline (using QoLD questionnaire)
Time frame: From baseline to 26 weeks of treatment
2 secondary outcomes
Safety
Time frame: After 26 weeks
Efficacy
Time frame: After 26 weeks
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 India.
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 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 India. 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 Quality of Life from baseline (using QoLD questionnaire) (time frame: From baseline to 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 31 Oct 2016.