Clinical trial

Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Name

NN304-1953

Description

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.

Trial arms

Trial start

2007-07-01

Estimated PCD

2008-03-01

Trial end

2008-03-01

Status

Completed

Treatment

insulin detemir

Start dose and frequency to be prescribed by the physician as a result of the actual clinical evaluation

Arms:

Other names:

Levemir®

Size

3593

Primary endpoint

Incidence of serious ADRs incl. major hypoglycemias

after 24 weeks

Eligibility criteria

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)

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 3593, 'type': 'ACTUAL'}}

Updated at

2023-11-02

1 organization

1 product

4 indications

Product

Indication

Indication

Indication

Indication

Organization