DiabetesNCT00700765
Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Indonesia.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions. 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?
- insulin detemir
- How many people
- 1,531 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2008to Jul 2008
- 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: Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion
Who may be able to join
- Type 1 or type 2 diabetes mellitus
Who cannot join
- Subjects who are unlikely to comply with the protocol
- Subjects who are currently being treated with Levemir®
- Subjects who previously were enrolled into the study
- Subjects with hypersensitivity to Levemir® or any of its excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.
- Being tested
- 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.
insulin detemirDrug
Also called Levemir®
For study drug, start dose and frequency of administration to be prescribed by the physician as a result of 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 (SADRs)
Measured: during treatment
Major hypoglycaemic events
Measured: during treatment
Secondary outcomes (6)
Number of serious adverse events
Measured: during treatment
Number of all adverse events
Measured: during treatment
Number of all hypoglycaemic events
Measured: the last 4 weeks of treatment
Weight changes
Measured: after 12 weeks
HbA1c
Measured: after 12 weeks and 26 weeks of treatment
Variability in fasting blood glucose (FBG) and average plasma glucose level
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2008
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
- 1,531 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
- NCT00700765
- Sponsor's protocol ID
- NN304-3528
- Status last verified
- Oct 2016
- First submitted
- 18 Jun 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, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00700765
- Acronym / sponsor ID
- NN304-3528
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,531 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 19 Jun 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 Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion
Key inclusion criteria (1 listed)
- Type 1 or type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Subjects who are unlikely to comply with the protocol
- Subjects who are currently being treated with Levemir®
- Subjects who previously were enrolled into the study
- Subjects with hypersensitivity to Levemir® or any of its excipients
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®For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation | Drug | A |
Primary outcome
Incidence of serious adverse drug reactions (SADRs)
Time frame: during treatment
Major hypoglycaemic events
Time frame: during treatment
6 secondary outcomes
Number of serious adverse events
Time frame: during treatment
Number of all adverse events
Time frame: during treatment
Number of all hypoglycaemic events
Time frame: the last 4 weeks of treatment
Weight changes
Time frame: after 12 weeks
HbA1c
Time frame: after 12 weeks and 26 weeks of treatment
Variability in fasting blood glucose (FBG) and average plasma glucose level
Time frame: after 12 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 1, run by Novo Nordisk A/S at 1 site in Indonesia.
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 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 Indonesia. 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 (SADRs) (time frame: during treatment). 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.