DiabetesEFFECTIVENCT00699179
Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Serbia and Montenegro.
Trial summary
This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 2,308 participants
- Where
- 1 siteSerbia and Montenegro
- Study dates
- Jun 2008to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 and 2 diabetes
Who may be able to join
- Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
- HbA1c greater than 7%
- Informed Consent
Who cannot join
- Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
Trial locations and contacts
1 site in 1 country.
Serbia and Montenegro1 site
Novo Nordisk Investigational Site
Belgrade, 11 070
About this study
Official title: EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice
This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.
- 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
There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a 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.
Change in HbA1c from baseline
Measured: After 6 months
Secondary outcomes (8)
Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus
Measured: after 12 weeks and 26 weeks compared to baseline
Change in FPG (glucose variability)
Measured: after 12 weeks and 26 weeks compared to baseline
Change in PPG (postprandial control)
Measured: after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections
Measured: at 12 weeks and 26 weeks of treatment
Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study
Measured: after 12 weeks and 26 weeks of treatment compared to baseline
Change in body weight and waist circumference
Measured: at 12 weeks and 26 weeks of treatment compared to baseline
Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits
Measured: at 12 weeks and 26 weeks of treatment compared to baseline
Number of adverse drug reactions (ADR)
Measured: after 12 weeks and 26 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 posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 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
- 2,308 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
- NCT00699179
- Sponsor's protocol ID
- BIASP-3557
- Acronym
- EFFECTIVE
- Status last verified
- Oct 2016
- First submitted
- 13 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
- EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice
- ClinicalTrials.gov ID
- NCT00699179
- Acronym / sponsor ID
- EFFECTIVE / BIASP-3557
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,308 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 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 Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: biphasic insulin aspart 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 and 2 diabetes
Key inclusion criteria (3 listed)
- Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
- HbA1c greater than 7%
- Informed Consent
Key exclusion criteria (3 listed)
- Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of 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® 30There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation. | Drug | A |
Primary outcome
Change in HbA1c from baseline
Time frame: After 6 months
8 secondary outcomes
Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus
Time frame: after 12 weeks and 26 weeks compared to baseline
Change in FPG (glucose variability)
Time frame: after 12 weeks and 26 weeks compared to baseline
Change in PPG (postprandial control)
Time frame: after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections
Time frame: at 12 weeks and 26 weeks of treatment
Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study
Time frame: after 12 weeks and 26 weeks of treatment compared to baseline
Change in body weight and waist circumference
Time frame: at 12 weeks and 26 weeks of treatment compared to baseline
Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits
Time frame: at 12 weeks and 26 weeks of treatment compared to baseline
Number of adverse drug reactions (ADR)
Time frame: after 12 weeks and 26 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 1, run by Novo Nordisk A/S at 1 site in Serbia and Montenegro.
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 3 inclusion and 3 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 Serbia and Montenegro. 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 from baseline (time frame: After 6 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.