DiabetesPREDICTIVE™NCT01545791
Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages Up to 110 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 1,037 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to Feb 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 Up to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient with type 1 or type 2 diabetes mellitus was eligible for the study, including newly diagnosed patients who had never received insulin or an insulin analogue before
Who may be able to join
- Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before
Who cannot join
- Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar
- Patients previously enrolled in this study
- Patients with a hypersensitivity to insulin detemir
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Through Intensification and Control to Target: An International Variability Evaluation
This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.
- 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
Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir users | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events
Measured: Weeks 0-26
Secondary outcomes (8)
Number of serious adverse events (SAEs)
Measured: Weeks 0-26
Number of all adverse events (AEs)
Measured: Weeks 0-26
Number of all hypoglycaemic events
Measured: In the 4 weeks preceeding week 26
Weight change
Measured: Week 0, week 26
Glycosylated haemoglobin (HbA1c)
Measured: Week 26
Variability in fasting plasma glucose (FPG)
Measured: Week 26
Average plasma glucose level
Measured: Week 26
Quality of Life as assessed by a treatment satisfaction questionnaire
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2006
- Primary completionFeb 2008
- Study completionFeb 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
- 1,037 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
- NCT01545791
- Sponsor's protocol ID
- NN304-1952
- Acronym
- PREDICTIVE™
- Status last verified
- Oct 2016
- First submitted
- 1 Mar 2012
- 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
- A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Through Intensification and Control to Target: An International Variability Evaluation
- ClinicalTrials.gov ID
- NCT01545791
- Acronym / sponsor ID
- PREDICTIVE™ / NN304-1952
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 7 Mar 2012 (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 the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir users | – | Drug: insulin detemir |
Who may qualify
- Ages
- Up to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with type 1 or type 2 diabetes mellitus was eligible for the study, including newly diagnosed patients who had never received insulin or an insulin analogue before
Key inclusion criteria (1 listed)
- Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before
Key exclusion criteria (3 listed)
- Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar
- Patients previously enrolled in this study
- Patients with a hypersensitivity to insulin detemir
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 detemirAdministered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician | Drug | Insulin detemir users |
Primary outcome
Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events
Time frame: Weeks 0-26
8 secondary outcomes
Number of serious adverse events (SAEs)
Time frame: Weeks 0-26
Number of all adverse events (AEs)
Time frame: Weeks 0-26
Number of all hypoglycaemic events
Time frame: In the 4 weeks preceeding week 26
Weight change
Time frame: Week 0, week 26
Glycosylated haemoglobin (HbA1c)
Time frame: Week 26
Variability in fasting plasma glucose (FPG)
Time frame: Week 26
Average plasma glucose level
Time frame: Week 26
Quality of Life as assessed by a treatment satisfaction questionnaire
Time frame: Week 26
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
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 1, 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 1 inclusion and 3 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 2 sites in Ireland, United Kingdom. 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?
Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events (time frame: Weeks 0-26). 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.