Insulin Glargine in Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00268645

First received: December 21, 2005

Last updated: January 10, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2005

Last Updated Date

January 10, 2011

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

For efficacy: FBG (Fasting Blood Glucose), HbA1c

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00268645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

For safety: ICA (Insulin Cell Antibody)

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Insulin Glargine in Type 2 Diabetes

Official Title ^ICMJE

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.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Insulin Glargine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

534

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00268645

Other Study ID Numbers ^ICMJE

HOE901_5036

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Edibe Taylan

Sanofi

Information Provided By

Sanofi

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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