Diabetes Mellitus, Type 2 Clinical Trial
— PREDICTIVE™Official title:
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study: Predictable Results and Experience in Diabetes Through Intensification and Control to Target: an International Variability Evaluation
This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this
observational study is to evaluate the incidence of serious adverse reactions (SARs) while
using Levemir® (insulin detemir) under normal clinical practice conditions.
Study conducted globally in 26 countries. Some countries participated in the study for only
3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey),
while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece,
India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and
United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.
| Status | Completed |
| Enrollment | 51170 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Age according to approved label in each country and physician discretion - Type 1 or 2 diabetes - Recently started treatment with insulin detemir at the discretion of the investigator. Before initiation of insulin detemir they should not have been treated with insulin - Selection at the discretion of the physician Exclusion Criteria: - Current treatment with Levemir® (insulin detemir) - Previously enrolled in the study - Hypersensitivity to Levemir® (insulin detemir) |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Belgium, Brazil, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Luxembourg, Netherlands, Russian Federation, Saudi Arabia, Slovenia, South Africa, Sweden, Tunisia, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. | Months 0-12 | No |
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