Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost. (ATOS)

Sanofi

Status: Completed

Conditions: Diabetes

Treatments: Drug: Insulin glargine (U300)

Study type: Observational

Funder types: Industry

Identifiers

NCT03703869

U1111-1215-0174 (Other Identifier)

OBS14708

Details and patient eligibility

About

Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

• Assess effectiveness in achieving glycemic goal measured by HbA1c;
• Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
• Assess requirement for intensification of therapy by additional antidiabetics.
• Assess incidence of hypoglycemia;
• Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
• Assess change in body weight.

Full description

Patients will be observed for one year

Enrollment: 4,589 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Signed patient informed consent;
• Type 2 diabetes mellitus;
• Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
• Hemoglobin A1c (HbA1c) >7.0 % and ≤11% within 3 months of study baseline;
• Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen

Exclusion criteria:

• Diabetes mellitus other than type 2;
• Contraindication to insulin glargine U300 according to local product labelling;

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

Trial design

4,589 participants in 1 patient group

Insulin glargine (U300)

Description:

Insulin glargine (U300) dosage and dosing time as per local product labeling

Treatment:

Drug: Insulin glargine (U300)