Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Glyburide; Drug: Lantus (insulin glargine [rDNA origin] injection); Drug: Metformin; Drug: Thiazolidinedione

Study type: Interventional

Funder types: Industry

Identifiers

NCT00046462

HOE901_4022

Details and patient eligibility

About

The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18 - 79 years of age
• With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months

Exclusion criteria

• Major cardiovascular events

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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)