N/A
Completed N=51,170
Observational Study to Evaluate the Safety of Levemir® in Diabetes
Diabetes · Diabetes Mellitus, Type 1 · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00659295 ↗
Enrolled (actual)
51,170
Serious AEs
0.4%
Results posted
Aug 2011
Primary outcomePrimary: Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events — 186; 93; 208; 112 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events |
186; 93; 208; 112; 109; 48 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00659295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.