Observational Study to Evaluate the Safety While Using Levemir®

Completed

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

• Registration Number: NCT00701155
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3593

Inclusion Criteria

• After the physician decision has been made to use insulin detemir, 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;
• Subjects currently being treated with insulin detemir;
• Subjects who previously enrolled in this study
• Subjects with a 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. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

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 ADRs incl. major hypoglycemias	after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Weight changes	after 24 weeks
Number of serious adverse events	after 24 weeks
Number of all adverse events	after 24 weeks
HbA1c	after 24 weeks
Subgroup analysis of hypoglycemias	after 24 weeks
Number of all hypoglycemic events	in the 4 weeks preceding the visits at 12 weeks and 24 weeks.
Variability in fasting Blood Sugar and average plasma glucose levels	after 24 weeks