DiabetesIDEALSNCT00700830
Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Algeria.
Trial summary
This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria. 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
- 1,976 participants
- Where
- 1 siteAlgeria
- Study dates
- Jan 2008to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes insulin naive patients
Who may be able to join
- Informed consent obtained before any trial-related activities
- Type 2 diabetes
- HbA1c between 7-9%
- Insulin naive
- Inadequate control with oral antidiabetics therapy as judged by investigator
Who cannot join
- Patients with type 1 diabetes
- Hypersensitivity to Levemir® or to any of the excipients
- Pregnancy, or desire of pregnancy within next 6 months
- HbA1c greater than or equal to 9%
- Known or suspected allergy to the trial product or to any of the excipients
- Subjects who are unlikely to comply with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus
This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.
- 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®
Initial dosage and the following dosages will be prescribed by the physician as a result of a 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.
Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.
Measured: During study
Secondary outcomes (3)
HbA1c
Measured: after 12 weeks (3 months) AND after 24 weeks (6 months)
FBG (Fasting Blood Glucose)
Measured: Monthly average for each month, and average of the past quarter
Weight
Measured: after 12 weeks (3 months) AND after 24 weeks (6 months)
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 completionSep 2009
- Study completionSep 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,976 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
- NCT00700830
- Sponsor's protocol ID
- NN304-3571
- Acronym
- IDEALS
- Status last verified
- Dec 2013
- First submitted
- 18 Jun 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
- Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00700830
- Acronym / sponsor ID
- IDEALS / NN304-3571
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,976 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (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 Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.
Study design
- Observational model
- Case only
- 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
- Type 2 diabetes insulin naive patients
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities
- Type 2 diabetes
- HbA1c between 7-9%
- Insulin naive
- Inadequate control with oral antidiabetics therapy as judged by investigator
Key exclusion criteria (6 listed)
- Patients with type 1 diabetes
- Hypersensitivity to Levemir® or to any of the excipients
- Pregnancy, or desire of pregnancy within next 6 months
- HbA1c greater than or equal to 9%
- Known or suspected allergy to the trial product or to any of the 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®Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation | Drug | A |
Primary outcome
Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.
Time frame: During study
3 secondary outcomes
HbA1c
Time frame: after 12 weeks (3 months) AND after 24 weeks (6 months)
FBG (Fasting Blood Glucose)
Time frame: Monthly average for each month, and average of the past quarter
Weight
Time frame: after 12 weeks (3 months) AND after 24 weeks (6 months)
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 Algeria.
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 5 inclusion and 6 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 Algeria. 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?
Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia. (time frame: During study). 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.