An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes

Completed

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

• Registration Number: NCT00738153
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 798

Inclusion Criteria

• Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Currently being treated with insulin detemir
• Previously enrolled in this study
• Hypersensitivity to insulin detemir or to any of the excipients
• Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
The incidence of serious adverse drug reactions, including major hypoglycaemic events	From baseline to 12 and 24 weeks of Levemir® therapy, respectively

Secondary Outcome Measures

Name	Time	Method
Number of all adverse events	From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Number of all hypoglycaemic events	in the 4 weeks preceding the visits at 12 weeks and 24 weeks.
Weight changes	at the end of study
HbA1c	at the end of study
Sub -group analysis of hypo risk	From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Number of serious adverse events	From baseline to 12 and 24 weeks of Levemir® therapy, respectively