Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes (IDEALS)

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

Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus

This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1976

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes insulin naive patients

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities
  • Type 2 diabetes
  • HbA1c between 7-9%
  • Insulin naive
  • Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion Criteria:

  • Patients with type 1 diabetes
  • Hypersensitivity to Levemir® or to any of the excipients
  • Pregnancy, or desire of pregnancy within next 6 months
  • HbA1c greater than or equal to 9%
  • Known or suspected allergy to the trial product or to any of the excipients
  • Subjects who are unlikely to comply with protocol

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
Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.
Time Frame: During study
During study

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 12 weeks (3 months) AND after 24 weeks (6 months)
after 12 weeks (3 months) AND after 24 weeks (6 months)
FBG (Fasting Blood Glucose)
Time Frame: Monthly average for each month, and average of the past quarter
Monthly average for each month, and average of the past quarter
Weight
Time Frame: after 12 weeks (3 months) AND after 24 weeks (6 months)
after 12 weeks (3 months) AND after 24 weeks (6 months)

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

January 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3571

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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