20 Week Bridging Study in Type II DM

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type II

Treatments: Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563225

HOE901_3506

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)