DiabetesNCT01542424
An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in North Macedonia.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus. 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 and insulin detemir
- How many people
- 1,889 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- Mar 2006to Dec 2006
- 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: Macedonian people with diabetes mellitus (Type 1 or Type 2)
Who may be able to join
- Macedonian people with diabetes mellitus (Type 1 or Type 2)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
North Macedonia1 site
Novo Nordisk Investigational Site
Skopje, MK-1000
About this study
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia
This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.
- Being tested
- biphasic insulin aspart 30, insulin detemir
- 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
Prescribed at the discretion of the physician
insulin detemirDrug
Prescribed at the discretion of the physician
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 users | Not described Receives: Drug: biphasic insulin aspart 30 | |
| IDet users | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin)
Secondary outcomes (5)
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)
Fasting plasma glucose (FPG)
Change in body weight
Incidence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,889 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
- NCT01542424
- Sponsor's protocol ID
- NN304-1763
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2012
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia
- ClinicalTrials.gov ID
- NCT01542424
- Acronym / sponsor ID
- NN304-1763
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,889 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 2 Mar 2012 (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 trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 users | – | Drug: biphasic insulin aspart 30 |
| IDet users | – | Drug: insulin detemir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Macedonian people with diabetes mellitus (Type 1 or Type 2)
Key inclusion criteria (1 listed)
- Macedonian people with diabetes mellitus (Type 1 or Type 2)
Key exclusion criteria (0 listed)
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 30Prescribed at the discretion of the physician | Drug | BIAsp 30 users |
| insulin detemirPrescribed at the discretion of the physician | Drug | IDet users |
Primary outcome
HbA1c (glycosylated haemoglobin)
5 secondary outcomes
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)
Fasting plasma glucose (FPG)
Change in body weight
Incidence of adverse events
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 Jan 2017.
- Results publicationDimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA.
- 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 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 0 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 Jan 2017. 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?
HbA1c (glycosylated haemoglobin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542424, which also lists 1 linked publication.
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 Jan 2017.