Observational Study to Evaluate the Safety of Levemir® in Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin detemir

• Registration Number: NCT00659295
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-16
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-06-16
• Results First Submitted QC: 2011-07-20
• Results First Posted: 2011-08-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51170

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 diabetes	insulin detemir	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.
Type 2 diabetes	insulin detemir	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Crawley, United Kingdom