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. Identifier: NCT00563225
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 26, 2007
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type II Drug: Insulin Glargine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus
Study Start Date : October 2002
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Insulin Glargine
    Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
    Other Name: Lantus

Primary Outcome Measures :
  1. To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.

Secondary Outcome Measures :
  1. To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00563225

Sponsors and Collaborators
Study Director: Choe Seong Choon Sanofi Identifier: NCT00563225     History of Changes
Other Study ID Numbers: HOE901_3506
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: November 26, 2007
Last Verified: November 2007

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