Observational Study to Evaluate the Safety of Levemir® in Diabetes (PREDICTIVE™)
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ClinicalTrials.gov Identifier: NCT00659295 |
Recruitment Status
:
Completed
First Posted
: April 16, 2008
Results First Posted
: August 16, 2011
Last Update Posted
: March 10, 2017
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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.
Condition or disease | Intervention/treatment |
---|---|
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 | Drug: insulin detemir |
Study Type : | Observational |
Actual Enrollment : | 51170 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |
Group/Cohort | Intervention/treatment |
---|---|
Type 1 diabetes
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
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Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
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Type 2 diabetes
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
|
- Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events [ Time Frame: Months 0-12 ]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.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659295
Belgium | |
Novo Nordisk Investigational Site | |
Brussels, Belgium, 1070 | |
Czech Republic | |
Novo Nordisk Investigational Site | |
Prague, Czech Republic, 16000 | |
Denmark | |
Novo Nordisk Investigational Site | |
Copenhagen S, Denmark, 2300 | |
Finland | |
Novo Nordisk Investigational Site | |
Espoo, Finland, FI-02600 | |
France | |
Novo Nordisk Investigational Site | |
Paris La défense cedex, France, 92932 | |
Greece | |
Novo Nordisk Investigational Site | |
Vouliagment, Greece, 16671 | |
Ireland | |
Novo Nordisk Investigational Site | |
Dublin 2, Ireland | |
Israel | |
Novo Nordisk Investigational Site | |
Kfar Saba, Israel, 44425 | |
Italy | |
Novo Nordisk Investigational Site | |
Rome, Italy, 00144 | |
Korea, Republic of | |
Novo Nordisk Investigational Site | |
Seoul, Korea, Republic of, 137-920 | |
Sweden | |
Novo Nordisk Investigational Site | |
Malmö, Sweden, 202 15 | |
Turkey | |
Novo Nordisk Investigational Site | |
Istanbul, Turkey, 34335 | |
United Kingdom | |
Novo Nordisk Investigational Site | |
Crawley, United Kingdom, RH11 9RT |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00659295 History of Changes |
Other Study ID Numbers: |
NN304-1677 |
First Posted: | April 16, 2008 Key Record Dates |
Results First Posted: | August 16, 2011 |
Last Update Posted: | March 10, 2017 |
Last Verified: | January 2017 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin, Globin Zinc Insulin Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |