DiabetesNCT00738153
An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Morocco.
Trial summary
This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 798 participants
- Where
- 1 siteMorocco
- Study dates
- Jun 2008to May 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before
Who may be able to join
- Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician
Who cannot join
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Currently being treated with insulin detemir
- Previously enrolled in this study
- Hypersensitivity to insulin detemir or to any of the excipients
- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus
This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin 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®
Start dose and frequency to be prescribed by the physician as a result of the 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.
The incidence of serious adverse drug reactions, including major hypoglycaemic events
Measured: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Secondary outcomes (6)
Number of serious adverse events
Measured: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Number of all adverse events
Measured: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Number of all hypoglycaemic events
Measured: in the 4 weeks preceding the visits at 12 weeks and 24 weeks.
Weight changes
Measured: at the end of study
HbA1c
Measured: at the end of study
Sub -group analysis of hypo risk
Measured: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionMay 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
- Time perspective
- Prospective
- Enrolment
- 798 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
- NCT00738153
- Sponsor's protocol ID
- NN304-3536
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 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
- Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00738153
- Acronym / sponsor ID
- NN304-3536
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 798 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 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 Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before
Key inclusion criteria (1 listed)
- Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician
Key exclusion criteria (5 listed)
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Currently being treated with insulin detemir
- Previously enrolled in this study
- Hypersensitivity to insulin detemir or to any of the excipients
- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.
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 to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
Primary outcome
The incidence of serious adverse drug reactions, including major hypoglycaemic events
Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
6 secondary outcomes
Number of serious adverse events
Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Number of all adverse events
Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Number of all hypoglycaemic events
Time frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks.
Weight changes
Time frame: at the end of study
HbA1c
Time frame: at the end of study
Sub -group analysis of hypo risk
Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
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 1, run by Novo Nordisk A/S at 1 site in Morocco.
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 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 Morocco. 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?
The incidence of serious adverse drug reactions, including major hypoglycaemic events (time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively). 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.