Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565162

HOE901_4041

Details and patient eligibility

About

To introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Insulin-naive Type 2 Diabetes Mellitus subjects, aged ≥18 years and on stable oral anti-diabetic treatment for >6 months requiring basal long-acting insulin (HbA1c >7.5 % and <12.0 %).

Exclusion criteria

• 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)