- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00806897
Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir® (LITHULEV1)
November 22, 2016 updated by: Novo Nordisk A/S
Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen
This study is conducted in Europe.
The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g.
Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
74
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
-
-
-
Vilnius, Lithuania, 01112
- 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diabetic subjects from specialists' (diabetologists, internists) care who are treated with intensive insulin treatment by prescription in line with governing prescribing rules.
At baseline subjects are treated with IIT containing NPH as basal insulin.
Description
Inclusion Criteria:
- Type 2 diabetic subjects on intensive insulin treatment (IIT)
- Eligibility for once daily insulin detemir administration
- Informed consent obtained before any observation-related activities
Exclusion Criteria:
- Known or suspected allergy to insulin detemir
- Subjects previously enrolled in the observation
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within 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
|
Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c from baseline
Time Frame: at 24 weeks
|
at 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body weight
Time Frame: at 12 weeks/24weeks
|
at 12 weeks/24weeks
|
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
January 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 10, 2008
First Posted (Estimate)
December 11, 2008
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 22, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-3701
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
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Newsoara Biopharma Co., Ltd.RecruitingT2DM (Type 2 Diabetes Mellitus)China
-
Shanghai Golden Leaf MedTec Co. LtdActive, not recruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on insulin detemir
-
Montefiore Medical CenterCompleted
-
University of AarhusCompletedDiabetes Mellitus, Type 1Denmark
-
Rigshospitalet, DenmarkCompletedWeight Gain | Diabetes Type 2Denmark
-
University of Texas Southwestern Medical CenterNovo Nordisk A/SWithdrawn
-
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
-
Institut de Recherches Cliniques de MontrealNovo Nordisk A/S; McMaster UniversityCompleted
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, Puerto Rico