DiabetesNCT00670722
Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Czechia.
Trial summary
This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart, insulin detemir and biphasic insulin aspart 30
- How many people
- 6,500 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2008to Dec 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: Patients with Type 2 diabetes
Who may be able to join
- Type 2 diabetes
- Current treatment with human soluble insulin, insulin NPH or premixed human insulin
- The selection of the subjects will be at the discretion of the individual physician
Who cannot join
- Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
- Previous enrolment in this study
- Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus
This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin aspart, 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 aspartDrug
Also called NovoRapid®
Intervention at the discretion of the physician
insulin detemirDrug
Intervention at the discretion of the physician
biphasic insulin aspart 30Drug
Intervention at the discretion of the physician
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin aspart | |
| B | Not described Receives: Drug: insulin detemir | |
| C | Not described Receives: Drug: biphasic insulin aspart 30 | |
| D | Not described Receives: Drug: insulin aspart; Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c after switch from human insulin to modern insulin treatment
Measured: After 24 weeks
Secondary outcomes (7)
Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment
Measured: After 12 and 24 weeks
Postprandial glycaemic control as measured by PPG
Measured: After 12 and 24 weeks
Glucose variability as measured by FPG
Measured: After 12 and 24 weeks
Insulin dose and number of injections
Measured: After 12 and 24 weeks
Body weight
Measured: After 12 and 24 weeks
Number of hypoglycaemic events
Measured: During treatment
Number of adverse drug reactions (ADR)
Measured: After 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 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
- 6,500 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
- NCT00670722
- Sponsor's protocol ID
- NN304-3517
- Status last verified
- Oct 2016
- First submitted
- 30 Apr 2008
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00670722
- Acronym / sponsor ID
- NN304-3517
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,500 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 May 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. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin aspart |
| B | – | Drug: insulin detemir |
| C | – | Drug: biphasic insulin aspart 30 |
| D | – | Drug: insulin aspart, Drug: insulin detemir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 diabetes
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Current treatment with human soluble insulin, insulin NPH or premixed human insulin
- The selection of the subjects will be at the discretion of the individual physician
Key exclusion criteria (4 listed)
- Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
- Previous enrolment in this study
- Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
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 aspartAlso: NovoRapid®Intervention at the discretion of the physician | Drug | A, D |
| insulin detemirIntervention at the discretion of the physician | Drug | B, D |
| biphasic insulin aspart 30Intervention at the discretion of the physician | Drug | C |
Primary outcome
HbA1c after switch from human insulin to modern insulin treatment
Time frame: After 24 weeks
7 secondary outcomes
Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment
Time frame: After 12 and 24 weeks
Postprandial glycaemic control as measured by PPG
Time frame: After 12 and 24 weeks
Glucose variability as measured by FPG
Time frame: After 12 and 24 weeks
Insulin dose and number of injections
Time frame: After 12 and 24 weeks
Body weight
Time frame: After 12 and 24 weeks
Number of hypoglycaemic events
Time frame: During treatment
Number of adverse drug reactions (ADR)
Time frame: After 12 and 24 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 28 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 Czechia.
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 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 28 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 Czechia. 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 after switch from human insulin to modern insulin treatment (time frame: After 24 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 28 Oct 2016.