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Insulin Glargine in Type 2 Diabetes

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: December 21, 2005
Last updated: January 10, 2011
Last verified: January 2011
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 Intervention Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

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

Estimated Enrollment: 534
Study Start Date: September 2004

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00268645

Istanbul, Turkey
Sponsors and Collaborators
Study Director: Edibe Taylan Sanofi
  More Information Identifier: NCT00268645     History of Changes
Other Study ID Numbers: HOE901_5036
Study First Received: December 21, 2005
Last Updated: January 10, 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 processed this record on September 20, 2017