Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

• To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

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

Details

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

Criteria

Inclusion criteria :

• Participants with type 2 diabetes mellitus

• Substudy inclusion criteria:

• Completion of the 6-month study period in main study (Visit 10)

• Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

• Age less than (<) 18 years

• HbA1c <7.0% or greater than (>) 10% at screening

• Diabetes other than type 2 diabetes mellitus

• Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose

• Any contraindication to use of insulin glargine as defined in the national product label

• Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit

• Use of an insulin pump in the last 6 months before screening visit

• Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit

• History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period

• Pregnant or breast-feeding women or women who intend to become pregnant during the study period

• Substudy exclusion criteria:

• Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.