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20 Week Bridging Study in Type II DM

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.
ClinicalTrials.gov Identifier: NCT00563225
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 26, 2007
Sponsor:
Information provided by:
Sanofi

November 21, 2007
November 26, 2007
November 26, 2007
October 2002
Not Provided
To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
Same as current
No Changes Posted
To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.
Same as current
Not Provided
Not Provided
 
20 Week Bridging Study in Type II DM
A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus
A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus Type II
Drug: Insulin Glargine
Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
Other Name: Lantus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2004
Not Provided

Inclusion Criteria:

  • Type 2 Diabetes Mellitus diagnosed at least 3 years ago
  • Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
  • Treated with OHA monotherapy over at least 1 year
  • HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
  • BMI < 40 kg/m2
  • No history of ketonemia
  • Women of childbearing potential using the medically approved contraceptive method
  • Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00563225
HOE901_3506
No
Not Provided
Not Provided
Not Provided
Sanofi
Not Provided
Study Director: Choe Seong Choon Sanofi
Sanofi
November 2007

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