Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard® (EVIDENCE)

January 30, 2017 updated by: Novo Nordisk A/S

Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus

This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

699

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

  • Romania
      • Bucharest, Romania, 010031
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes patiens failing on oral anti-diabetic agents

Description

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c greater than 7.0% and/or hypoglycaemia
  • variable FBG and/or weight increase
  • the selection of the subjects will be at the discretion of the participating physician

Exclusion Criteria:

  • non-type 2 diabetes
  • current treatment with Levemir® or Insulatard®
  • hypersensitivity to Levemir® or Insulatard® or to any of the excipients
  • women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 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 prescribed by the physician as a result of a normal clinical evaluation
B
Drug: insulin NPH
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight
Time Frame: after 6 months of treatment
after 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values
Time Frame: after 6 months of treatment
after 6 months of treatment
The incidence of hypoglycaemic events
Time Frame: after 6 months of treatment
after 6 months of treatment
Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.
Time Frame: after 6 months of treatment
after 6 months of treatment
The general well-being by using the WHO-5 well-being questionnaire.
Time Frame: after 6 months of treatment
after 6 months of treatment
The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire
Time Frame: after 6 months of treatment
after 6 months of treatment
The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit.
Time Frame: after 6 months of treatment
after 6 months 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.

General Publications

  • Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association

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

November 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1976

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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