- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715351
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes
November 23, 2016 updated by: Novo Nordisk A/S
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
342
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ljubljana, Slovenia, SI-1000
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Insulin naïve patients with type 2 diabetes treated with oral antidiabetics
Description
Inclusion Criteria:
- Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.
Exclusion Criteria:
- Type 1 diabetes
- Previous use of insulin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
|
Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
|
B
|
Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight change
Time Frame: at 3 months and 6 months after baseline
|
at 3 months and 6 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hypoglycemic events
Time Frame: at 3 months and 6 months after baseline
|
at 3 months and 6 months after baseline
|
Changes in glycaemic parameters
Time Frame: at 3 months and 6 months after baseline
|
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
|
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
|
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
|
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
|
at 3 months and 6 months after baseline
|
Changes in doses
Time Frame: at 3 months and 6 months after baseline
|
at 3 months and 6 months after baseline
|
HbA1c
Time Frame: at 3 months and 6 months after baseline
|
at 3 months and 6 months after baseline
|
Changes in daily blood glucose values
Time Frame: at 3 months and 6 months after baseline
|
at 3 months and 6 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
July 11, 2008
First Submitted That Met QC Criteria
July 11, 2008
First Posted (Estimate)
July 15, 2008
Study Record Updates
Last Update Posted (Estimate)
November 25, 2016
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-1896
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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