20 Week Bridging Study in Type II DM

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

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.