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

December 21, 2005
January 10, 2011
September 2004
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For efficacy: FBG (Fasting Blood Glucose), HbA1c
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Complete list of historical versions of study NCT00268645 on ClinicalTrials.gov Archive Site
For safety: ICA (Insulin Cell Antibody)
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Insulin Glargine in Type 2 Diabetes
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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
534
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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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00268645
HOE901_5036
Not Provided
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Sanofi
Not Provided
Study Director: Edibe Taylan Sanofi
Sanofi
January 2011

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