DiabetesNCT00715351
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Slovenia.
Trial summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® 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 2
- What is being tested?
- insulin detemir and insulin NPH
- How many people
- 342 participants
- Where
- 1 siteSlovenia
- Study dates
- May 2007to 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: Insulin naïve patients with type 2 diabetes treated with oral antidiabetics
Who may be able to join
- Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.
Who cannot join
- Type 1 diabetes
- Previous use of insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, insulin NPH
- 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
Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
insulin NPHDrug
Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir | |
| B | Not described Receives: Drug: insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Measured: at 3 months and 6 months after baseline
Secondary outcomes (9)
Hypoglycemic events
Measured: at 3 months and 6 months after baseline
Changes in glycaemic parameters
Measured: at 3 months and 6 months after baseline
Safety parameters by collecting (serious) adverse events and the pregnancies.
Measured: at 3 months and 6 months after baseline
Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).
Measured: at 3 months and 6 months after baseline
Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)
Measured: at 3 months and 6 months after baseline
Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).
Measured: at 3 months and 6 months after baseline
Changes in doses
Measured: at 3 months and 6 months after baseline
HbA1c
Measured: at 3 months and 6 months after baseline
Changes in daily blood glucose values
Measured: at 3 months and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startMay 2007
- 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
- Time perspective
- Prospective
- Enrolment
- 342 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
- NCT00715351
- Sponsor's protocol ID
- NN304-1896
- Status last verified
- Nov 2016
- First submitted
- 11 Jul 2008
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00715351
- Acronym / sponsor ID
- NN304-1896
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Jul 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 trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
| B | – | Drug: insulin NPH |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Insulin naïve patients with type 2 diabetes treated with oral antidiabetics
Key inclusion criteria (1 listed)
- Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Previous use of insulin
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 detemirPhysician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician | Drug | A |
| insulin NPHPhysician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician | Drug | B |
Primary outcome
Body weight change
Time frame: at 3 months and 6 months after baseline
9 secondary outcomes
Hypoglycemic events
Time frame: at 3 months and 6 months after baseline
Changes in glycaemic parameters
Time frame: at 3 months and 6 months after baseline
Safety parameters by collecting (serious) adverse events and the pregnancies.
Time frame: at 3 months and 6 months after baseline
Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).
Time frame: at 3 months and 6 months after baseline
Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)
Time frame: at 3 months and 6 months after baseline
Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).
Time frame: at 3 months and 6 months after baseline
Changes in doses
Time frame: at 3 months and 6 months after baseline
HbA1c
Time frame: at 3 months and 6 months after baseline
Changes in daily blood glucose values
Time frame: at 3 months and 6 months after baseline
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 25 Nov 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 2, run by Novo Nordisk A/S at 1 site in Slovenia.
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 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 25 Nov 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 Slovenia. 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?
Body weight change (time frame: at 3 months and 6 months after baseline). 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 25 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.