DiabetesNCT00842894
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in North Macedonia.
Trial summary
This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia. 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?
- insulin detemir and biphasic insulin aspart 30
- How many people
- 3,421 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- May 2009to Oct 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: Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label
Who cannot join
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia
This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, 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.
insulin detemirDrug
Also called NN304, Levemir®
Safety and effectiveness data collection in connection with the use of the drug.
biphasic insulin aspart 30Drug
Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir | Not described Receives: Drug: insulin detemir | |
| Biphasic insulin aspart 30 | 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 serious adverse drug reactions (SADRs)
Measured: after 26 weeks
Secondary outcomes (7)
Number of all minor hypoglycaemic events
Measured: during 4 weeks preceding each visit
Number of all major hypoglycaemic events
Measured: during 13 weeks preceding each visit
HbA1c
Measured: after 26 weeks
Percentage of subjects to reach HbA1c below 7.0%
Measured: after 13 weeks and 26 weeks
The effect on glycaemic control as measured by FPG (fasting plasma glucose)
Measured: after 13 weeks and 26 weeks
The effect on glycamic control as measured by PG profile
Measured: after 13 weeks and 26 weeks
Change in body weight
Measured: after 13 weeks and 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 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionOct 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
- 3,421 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
- NCT00842894
- Sponsor's protocol ID
- NN304-3716
- Status last verified
- Nov 2012
- First submitted
- 11 Feb 2009
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia
- ClinicalTrials.gov ID
- NCT00842894
- Acronym / sponsor ID
- NN304-3716
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,421 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 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 Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir | – | Drug: insulin detemir |
| Biphasic insulin aspart 30 | – | Drug: biphasic insulin aspart 30 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (1 listed)
- After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label
Key exclusion criteria (5 listed)
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 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 |
|---|---|---|
| insulin detemirAlso: NN304, Levemir®Safety and effectiveness data collection in connection with the use of the drug. | Drug | Insulin detemir |
| biphasic insulin aspart 30Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice. | Drug | Biphasic insulin aspart 30 |
Primary outcome
Incidence of serious adverse drug reactions (SADRs)
Time frame: after 26 weeks
7 secondary outcomes
Number of all minor hypoglycaemic events
Time frame: during 4 weeks preceding each visit
Number of all major hypoglycaemic events
Time frame: during 13 weeks preceding each visit
HbA1c
Time frame: after 26 weeks
Percentage of subjects to reach HbA1c below 7.0%
Time frame: after 13 weeks and 26 weeks
The effect on glycaemic control as measured by FPG (fasting plasma glucose)
Time frame: after 13 weeks and 26 weeks
The effect on glycamic control as measured by PG profile
Time frame: after 13 weeks and 26 weeks
Change in body weight
Time frame: after 13 weeks and 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 15 Aug 2014.
- 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 North Macedonia.
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 15 Aug 2014. 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 North Macedonia. 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 serious adverse drug reactions (SADRs) (time frame: 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 15 Aug 2014.