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

August 13, 2014 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

798

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Casablanca, Morocco, 20000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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