Insulin Glargine in Type 2 Diabetes

January 10, 2011 updated by: Sanofi

Open Trial of the Safety and Efficacy of Lantus for Insulin Naive Type 2 Diabetes Mellitus Patients or Patients Who Use Insulin Combined With 1 or More Oral Antidiabetic Drugs and Don't Have Good Glycemic Control.

The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

534

Phase

  • Phase 4

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

  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis

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

Description

Inclusion Criteria:

  • Type 2 Diabetes Mellitus patients,
  • Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents,
  • Patients with HbA1C>8
  • Patients able to self-measure its blood glucose levels.

Exclusion Criteria:

  • According to package insert information (Summary of Product Characteristics)

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
For efficacy: FBG (Fasting Blood Glucose), HbA1c

Secondary Outcome Measures

Outcome Measure
For safety: ICA (Insulin Cell Antibody)

Collaborators and Investigators

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

Sponsor

Sanofi

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

September 1, 2004

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_5036

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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