DiabetesNCT00793273
Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Switzerland.
Trial summary
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated. 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 detemir
- How many people
- 1,074 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2008to Jan 2011
- 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 from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.
Who may be able to join
- Patients with type 2 diabetes mellitus
- Insulin-naive or currently treated with another basal insulin
- Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®
Who cannot join
- Type 1 diabetes mellitus
- Patients treated with short acting or with premix insulin
- Women who are pregnant, breast feeding or have the intention to become pregnant
- Known or suspected allergy to the study product or related product
- Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir
- 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 Levemir®, NN304
Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c of treatment
Measured: after 12 to 16 weeks
Change in FPG (fasting plasma glucose) of treatment
Measured: after 12 to 16 weeks
Secondary outcomes (2)
Occurrence of adverse events
Measured: after 12 to 16 weeks
Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation
Measured: after 12 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionJan 2011
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
- 1,074 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
- NCT00793273
- Sponsor's protocol ID
- NN304-3694
- Status last verified
- May 2014
- First submitted
- 18 Nov 2008
- 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
- Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.
- ClinicalTrials.gov ID
- NCT00793273
- Acronym / sponsor ID
- NN304-3694
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,074 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Nov 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. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | 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 from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus
- Insulin-naive or currently treated with another basal insulin
- Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus
- Patients treated with short acting or with premix insulin
- Women who are pregnant, breast feeding or have the intention to become pregnant
- Known or suspected allergy to the study product or related product
- Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)
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: Levemir®, NN304Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice | Drug | A |
Primary outcome
Change in HbA1c of treatment
Time frame: after 12 to 16 weeks
Change in FPG (fasting plasma glucose) of treatment
Time frame: after 12 to 16 weeks
2 secondary outcomes
Occurrence of adverse events
Time frame: after 12 to 16 weeks
Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation
Time frame: after 12 to 16 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 Switzerland.
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 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 Switzerland. 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 of treatment (time frame: after 12 to 16 weeks). 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 15 Aug 2014.