- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00687284
Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus (START)
October 27, 2016 updated by: Novo Nordisk A/S
Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.
This study is conducted in Europe.
An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2188
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
-
-
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Kosice, Slovakia, 040 01
- Novo Nordisk INvestigational Site
-
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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
Diabetes mellitus type 2
Description
Inclusion Criteria:
- Patients with type 2 diabetes
- Patients inadequately controlled by OAD
- Patients willing to sign informed consent
- Selection of study participants at the discretion of the physician
- Particular attention should be paid to the drug interactions that are listed within the product label
Exclusion Criteria:
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
- Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
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
|
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in glycaemic control as measured by HbA1c.
Time Frame: For the duration of the study
|
For the duration of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%
Time Frame: After 12 weeks and 24 weeks
|
After 12 weeks and 24 weeks
|
The effect on glycaemic control as measured by FPG
Time Frame: After 12 weeks and 24 weeks
|
After 12 weeks and 24 weeks
|
Change in body weight
Time Frame: After 12 weeks and 24 weeks
|
After 12 weeks and 24 weeks
|
Change in waist and hip perimeter
Time Frame: After 12 weeks and 24 weeks
|
After 12 weeks and 24 weeks
|
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
February 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 27, 2008
First Submitted That Met QC Criteria
May 27, 2008
First Posted (Estimate)
May 30, 2008
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-3515
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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