DiabetesUPGRADENCT00737776
Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in South Korea.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 30
- How many people
- 1,068 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Jan 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: Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30
Who may be able to join
- Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
- Patient who signed on informed consent form
Who cannot join
- Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
- Patients who were previously enrolled in this study
- Patients with a hypersensitivity to NovoMix® 30 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: NovoMix® 30 UPGRADE (NovoMix® 30 Use for Progressed Glycemic Control in Realistic Administration to DiabEtes Mellitus): A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Efficacy and Safety Study in Patients 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 efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.
- Being tested
- biphasic insulin aspart 30
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, 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, NovoLog® Mix 70/30
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.
HbA1c change
Measured: at the end of study after 26 weeks
Secondary outcomes (14)
Number of serious adverse drug reactions
Measured: during the study
Number of serious adverse events
Measured: during the study
Number of all major (daytime and nocturnal) hypoglycaemic events
Measured: during the study
Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection
Measured: during the study
Number of major hypoglycaemic events related to physical exercise of at least 30 min
Measured: during the study
Number of all minor (daytime and nocturnal) hypoglycaemic events
Measured: during the study
Weight (BMI) change
Measured: at the end of study after 26 weeks
Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change
Measured: at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 6.5%
Measured: at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 7.0%
Measured: at the end of study after 26 weeks
Percentage of patients reaching the physician's own target recommendation
Measured: at the end of study after 26 weeks
Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level
Measured: at the end of study after 26 weeks
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level
Measured: at the end of study after 26 weeks
Diabetes Fear of Self-Injection Questionnaire (D-FISQ)
Measured: at the end of study 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 posted20 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJan 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
- 1,068 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
- NCT00737776
- Sponsor's protocol ID
- BIASP-3547
- Acronym
- UPGRADE
- Status last verified
- Oct 2016
- First submitted
- 19 Aug 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
- NovoMix® 30 UPGRADE (NovoMix® 30 Use for Progressed Glycemic Control in Realistic Administration to DiabEtes Mellitus): A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Efficacy and Safety Study in Patients Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00737776
- Acronym / sponsor ID
- UPGRADE / BIASP-3547
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,068 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Aug 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 efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.
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
- Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30
Key inclusion criteria (2 listed)
- Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
- Patient who signed on informed consent form
Key exclusion criteria (4 listed)
- Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
- Patients who were previously enrolled in this study
- Patients with a hypersensitivity to NovoMix® 30 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, NovoLog® Mix 70/30Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
Primary outcome
HbA1c change
Time frame: at the end of study after 26 weeks
14 secondary outcomes
Number of serious adverse drug reactions
Time frame: during the study
Number of serious adverse events
Time frame: during the study
Number of all major (daytime and nocturnal) hypoglycaemic events
Time frame: during the study
Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection
Time frame: during the study
Number of major hypoglycaemic events related to physical exercise of at least 30 min
Time frame: during the study
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time frame: during the study
Weight (BMI) change
Time frame: at the end of study after 26 weeks
Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change
Time frame: at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 6.5%
Time frame: at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 7.0%
Time frame: at the end of study after 26 weeks
Percentage of patients reaching the physician's own target recommendation
Time frame: at the end of study after 26 weeks
Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level
Time frame: at the end of study after 26 weeks
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level
Time frame: at the end of study after 26 weeks
Diabetes Fear of Self-Injection Questionnaire (D-FISQ)
Time frame: at the end of study 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 1, run by Novo Nordisk A/S at 1 site in South Korea.
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 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 South Korea. 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?
HbA1c change (time frame: at the end of study after 26 weeks). 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.