Observational Study to Evaluate the Safety of Levemir® in Diabetes

Completed

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

• Registration Number: NCT00706017
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2282

Inclusion Criteria

• Type 1 or 2 diabetes
• Including newly diagnosed not on insulin or insulin analogue treatment
• Selection at the discretion of the physician
• Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion Criteria

• Current treatment with Levemir®
• Previously enrolled in the study
• Hypersensitivity to Levemir®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)	during treatment

Secondary Outcome Measures

Name	Time	Method
Weight	during treatment
Glucose control measures	during treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇲🇽 Mexico City, Mexico