Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment

• Status: Completed
• Trial end date: 2017-07-24
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

• Evolution of fasting plasma glucose

• Evolution of insulin dose and body weight

• Hypoglycemia incidence

• Safety

• Patients satisfaction when they change their insulin for HOE901-U300

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria :

• Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist

• HbA1c > 7.5%

Exclusion criteria:

• Patients with high dose of insulin (>1.2 U/kg)

• Use of prandial insulin

• Change of dose of antidiabetic drugs within the last 8 weeks

• Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks

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