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
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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.
1 other identifier
observational
2,188
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 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
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedOctober 28, 2016
October 1, 2016
2.3 years
May 27, 2008
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in glycaemic control as measured by HbA1c.
For the duration of the study
Secondary Outcomes (4)
Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%
After 12 weeks and 24 weeks
The effect on glycaemic control as measured by FPG
After 12 weeks and 24 weeks
Change in body weight
After 12 weeks and 24 weeks
Change in waist and hip perimeter
After 12 weeks and 24 weeks
Study Arms (1)
A
Interventions
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Eligibility Criteria
Diabetes mellitus type 2
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Košice, 040 01, Slovakia
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
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 30, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 28, 2016
Record last verified: 2016-10