Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus (LevSafeQD)

October 27, 2016 updated by: Novo Nordisk A/S
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

747

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3542
        • Novo Nordisk Investigational Site

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

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type 2 diabetic patients

Description

Inclusion Criteria:

  • After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes 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 or studies related to NovoMix 30;
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

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®, NN304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events
Time Frame: For the duration of the study (32 weeks)
For the duration of the study (32 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events
Time Frame: For the duration of the study
For the duration of the study
Number of all adverse events
Time Frame: For the duration of the study
For the duration of the study
Number of all - daytime and nocturnal - hypoglycaemic events
Time Frame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits
In the 4 weeks before baseline compared to 4 weeks before interim and final visits
Weight changes compared to baseline
Time Frame: At the end of the study
At the end of the study
HbA1c compared to baseline
Time Frame: At the end of the study
At the end of the study
Fasting glucose level control compared to baseline as measured by FBG
Time Frame: After 16 and 32 weeks of treatment
After 16 and 32 weeks of treatment

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

May 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3551

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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