- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01548248
Efficacy and Safety of Levemir® Used as Basal Insulin
January 30, 2017 updated by: Novo Nordisk A/S
An Observational 3-months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
This study is conducted in Europe.
The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
631
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
-
-
-
Bratislava, Slovakia, 811 05
- 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
Any subject with type 1 or type 2 diabetes treated with human insulin NPH in whom at the discretion of the participating physicians it was decided to switch insulin treatment to the long-acting insulin analogue insulin detemir in combination with insulin aspart.
The selection of the subjects was at the discretion of the participating physicians.
Description
Inclusion Criteria:
- Type 1 or type 2 diabetes treated with insulin NPH
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Levemir® users
|
Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician.
The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation.
The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician.
The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation.
The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in HbA1c (glycosylated haemoglobin)
|
Secondary Outcome Measures
Outcome Measure |
---|
Number of adverse events
|
Number of hypoglycaemic events
|
Change in weight
|
Change in fasting plasma glucose (FPG)
|
Change in 4-points glucose profiles
|
Change in lipid profile
|
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.
General Publications
- Zuzana N et al; Effect of Basal Insulin Detemir on Weight and Hypoglycemia in T1DM and T2DM; 2025-PO; 69th Scientific Sessions (2009); American Diabetes Association
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
January 1, 2006
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 5, 2012
First Posted (Estimate)
March 8, 2012
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-1928
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.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaRecruiting
Clinical Trials on insulin detemir
-
Montefiore Medical CenterCompleted
-
Rigshospitalet, DenmarkCompletedWeight Gain | Diabetes Type 2Denmark
-
University of AarhusCompletedDiabetes Mellitus, Type 1Denmark
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesTaiwan
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Denmark
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesIndia
-
University of Texas Southwestern Medical CenterNovo Nordisk A/SWithdrawn
-
Institut de Recherches Cliniques de MontrealNovo Nordisk A/S; McMaster UniversityCompleted
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany, South Africa, Russian Federation, Former Serbia and Montenegro, North Macedonia