DiabetesNCT00771680
Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice… 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, biphasic insulin aspart 30 and insulin aspart
- How many people
- 10,408 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2008to Jul 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 of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator
Who cannot join
- In accordance with approved label
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.
This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, biphasic insulin aspart 30, insulin aspart
- 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
Start dose and frequency at the discretion of the physician following clinical practice
biphasic insulin aspart 30Drug
Start dose and frequency at the discretion of the physician following clinical practice
insulin aspartDrug
Start dose and frequency at the discretion of the physician following clinical practice
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir; Drug: biphasic insulin aspart 30; Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: at baseline visit and during 3, 6, 9 and 12 months
Serious adverse drug reactions including major hypoglycaemic events
Measured: during 12 months of treatment
Secondary outcomes (7)
Number of serious adverse drug reactions
Measured: during 12 months of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Measured: during 12 months of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Measured: During 4 weeks prior to each study visit
Weight (BMI) change
Measured: At 6 and 12 months
Variability in fasting blood glucose values and average (mean) fasting blood glucose level
Measured: At baseline visit and after 6 and 12 months treatment
Average post-prandial blood glucose level (2h after dinner)
Measured: At baseline visit and after 6 and 12 months treatment
Quality of Life (QoL) as assessed by patient questionnaire
Measured: At baseline and the end of 6 and 12 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionJul 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
- 10,408 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
- NCT00771680
- Sponsor's protocol ID
- INS-3655
- Status last verified
- Oct 2016
- First submitted
- 9 Oct 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
- Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00771680
- Acronym / sponsor ID
- INS-3655
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,408 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Oct 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 and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir, Drug: biphasic insulin aspart 30, Drug: insulin aspart |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (1 listed)
- Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator
Key exclusion criteria (1 listed)
- In accordance with approved label
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 detemirStart dose and frequency at the discretion of the physician following clinical practice | Drug | A |
| biphasic insulin aspart 30Start dose and frequency at the discretion of the physician following clinical practice | Drug | A |
| insulin aspartStart dose and frequency at the discretion of the physician following clinical practice | Drug | A |
Primary outcome
HbA1c
Time frame: at baseline visit and during 3, 6, 9 and 12 months
Serious adverse drug reactions including major hypoglycaemic events
Time frame: during 12 months of treatment
7 secondary outcomes
Number of serious adverse drug reactions
Time frame: during 12 months of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Time frame: during 12 months of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time frame: During 4 weeks prior to each study visit
Weight (BMI) change
Time frame: At 6 and 12 months
Variability in fasting blood glucose values and average (mean) fasting blood glucose level
Time frame: At baseline visit and after 6 and 12 months treatment
Average post-prandial blood glucose level (2h after dinner)
Time frame: At baseline visit and after 6 and 12 months treatment
Quality of Life (QoL) as assessed by patient questionnaire
Time frame: At baseline and the end of 6 and 12 months 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 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
2 sites in 2 countries: 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 2 sites in 2 countries.
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 1 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 2 sites in Russia, Ukraine. 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 (time frame: at baseline visit and during 3, 6, 9 and 12 months). The study lists 2 primary outcomes in all. 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.