DiabetesNCT00735501
Observational Study to Observe the Safety of Levemir® Treatment in Patients 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 observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment. 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
- 314 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2008to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 or above, with type 2 diabetes, who together with their physician, have decided to switch to Levemir® from human basal insulin treatment
Who may be able to join
- Any patient with type 2 diabetes
- Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
- Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient
Who cannot join
- Known or suspected allergy to study product(s) or related products.
- Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes
This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.
- 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®
Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation
| 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.
Incidence of serious adverse drug reactions, including major hypoglycaemic events
Measured: After 26 weeks
Secondary outcomes (5)
Number of all hypoglycaemic events
Measured: at 12 weeks and 26 weeks
Number of all adverse drug reactions
Measured: after 12 and 26 weeks
HbA1c
Measured: at 12 and 26 weeks
Variability in fasting plasma glucose (FPG) values and average FPG levels at visits
Measured: at 12 and 26 weeks
Weight changes
Measured: at 12 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 posted15 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionMay 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
- 314 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
- NCT00735501
- Sponsor's protocol ID
- NN304-1938
- Status last verified
- Oct 2014
- First submitted
- 13 Aug 2008
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00735501
- Acronym / sponsor ID
- NN304-1938
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Aug 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 observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.
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 aged 18 or above, with type 2 diabetes, who together with their physician, have decided to switch to Levemir® from human basal insulin treatment
Key inclusion criteria (3 listed)
- Any patient with type 2 diabetes
- Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
- Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient
Key exclusion criteria (2 listed)
- Known or suspected allergy to study product(s) or related products.
- Pregnancy or breastfeeding or intention of becoming pregnant within the 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: Levemir®Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation | Drug | A |
Primary outcome
Incidence of serious adverse drug reactions, including major hypoglycaemic events
Time frame: After 26 weeks
5 secondary outcomes
Number of all hypoglycaemic events
Time frame: at 12 weeks and 26 weeks
Number of all adverse drug reactions
Time frame: after 12 and 26 weeks
HbA1c
Time frame: at 12 and 26 weeks
Variability in fasting plasma glucose (FPG) values and average FPG levels at visits
Time frame: at 12 and 26 weeks
Weight changes
Time frame: at 12 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 29 Oct 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
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 3 inclusion and 2 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 29 Oct 2014. 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 Denmark, Sweden. 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, including major hypoglycaemic events (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 29 Oct 2014.