Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.
Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.
1 other identifier
observational
1,074
1 country
1
Brief Summary
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 18, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedAugust 15, 2014
May 1, 2014
2.2 years
November 18, 2008
August 13, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Change in HbA1c of treatment
after 12 to 16 weeks
Change in FPG (fasting plasma glucose) of treatment
after 12 to 16 weeks
Secondary Outcomes (2)
Occurrence of adverse events
after 12 to 16 weeks
Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation
after 12 to 16 weeks
Study Arms (1)
A
Interventions
Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice
Eligibility Criteria
Patients from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.
You may qualify if:
- Patients with type 2 diabetes mellitus
- Insulin-naive or currently treated with another basal insulin
You may not qualify if:
- Type 1 diabetes mellitus
- Patients treated with short acting or with premix insulin
- Women who are pregnant, breast feeding or have the intention to become pregnant
- Known or suspected allergy to the study product or related product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Zurich, Oerlikon, CH-8050, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2008
First Posted
November 19, 2008
Study Start
November 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 15, 2014
Record last verified: 2014-05