Observational Study to Observe the Safety of Levemir® Treatment in Patients With Type 2 Diabetes

Completed

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

• Registration Number: NCT00735501
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-15
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

• Any patient with type 2 diabetes
• Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
• Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria

• Known or suspected allergy to study product(s) or related products.
• Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months

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 serious adverse drug reactions, including major hypoglycaemic events	After 26 weeks

Secondary Outcome Measures

Name	Time	Method
Number of all adverse drug reactions	after 12 and 26 weeks
HbA1c	at 12 and 26 weeks
Number of all hypoglycaemic events	at 12 weeks and 26 weeks
Variability in fasting plasma glucose (FPG) values and average FPG levels at visits	at 12 and 26 weeks
Weight changes	at 12 and 26 weeks