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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 19, 2008

Last Updated Date

April 29, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

The incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Number of serious adverse events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]
Number of all adverse events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]
Number of all hypoglycaemic events [ Time Frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks. ] [ Designated as safety issue: No ]
Weight changes [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
Sub -group analysis of hypo risk [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus

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

Study Phase

Study Type ^†

Observational

Study Design ^†

Other, Prospective

Condition ^†

Diabetes Mellitus

Intervention ^†

Drug: insulin detemir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

980

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Morocco

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738153

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Secondary IDs ^††

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

Study Director:

Zakia By, MBA

Novo Nordisk Pharma S.A.S

Information Provided By

Novo Nordisk

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.