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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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268645

Locations
Turkey
Sanofi-Aventis
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268645     History of Changes
Other Study ID Numbers: HOE901_5036
Study First Received: December 21, 2005
Last Updated: January 10, 2011
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013