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Insulin Glargine in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268645
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : January 11, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. For efficacy: FBG (Fasting Blood Glucose), HbA1c

Secondary Outcome Measures :
  1. For safety: ICA (Insulin Cell Antibody)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268645

Istanbul, Turkey
Sponsors and Collaborators
Study Director: Edibe Taylan Sanofi Identifier: NCT00268645     History of Changes
Other Study ID Numbers: HOE901_5036
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs