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.

Sanofi4,589 enrolled

Overview

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.

Patients will be observed for one year

Study Type

OBSERVATIONAL

Enrollment

4,589

Conditions

Diabetes

Interventions

Insulin glargine (U300)DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Eligibility

Medical Language ↔ Plain English

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.

Locations (388)

Investigational Site Number 1700001

Barranquilla, Colombia

Investigational Site Number 1700004

Bogotá, Colombia

Investigational Site Number 1700010

Bogotá, Colombia

Investigational Site Number 1700005

Cali, Colombia

Investigational Site Number 1700009

Cali, Colombia

Investigational Site Number 1700003

Outcomes

Primary Outcomes

Change in HbA1c at month 6

Percentage of patients achieving Hemoglobin A1c \<7.0%.

Time frame: Baseline, month 6

Secondary Outcomes

Change in HbA1c

Change from baseline in HbA1c at 3, 6, and 12 months

Time frame: Baseline, months 3, 6, 12

Change in fasting plasma glucose

Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months

Time frame: Baseline, months 3, 6, 12

Change in Self-Monitored Plasma Glucose

Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months

Time frame: Baseline, months 3, 6, 12

Hypoglycemia

Number of participants with symptomatic hypoglycemic events

Time frame: Baseline to month 12

Adverse events

Number of participants with Adverse Events

Time frame: Baseline to month 12

Serious adverse events

Number of participants with Serious Adverse Events

Time frame: Baseline to month 12

Body weight

Change in average body weight

Time frame: Baseline to month 12