Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment (Transition II)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine (U300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02967237

GLARGL07667

U1111-1176-6203 (Other Identifier)

2015-002416-33 (EudraCT Number)

Details and patient eligibility

About

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

Full description

The total study duration per patient is approximately 28 weeks.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

Insulin glargine (U300)

Experimental group

Description:

Type 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen

Treatment:

Drug: insulin glargine (U300)